Nothing Special   »   [go: up one dir, main page]

LGC Pharma Current

Download as pdf or txt
Download as pdf or txt
You are on page 1of 699

Together,

QUALITY ISO 17034 | ISO/IEC 17025


ISO 9001 | GMP

beyond the lgcstandards.com/mikromol

standard.
High quality reference standards
for the pharmaceutical industry.
2023 | Issue 1.0
Welcome to Mikromol.
We work with you to
provide better, safer
medicines.
For more than 29 years Mikromol Over
has produced high quality
reference standards used in
the pharmaceutical industry for:—
7,000
reference standards
Analytical development
— Method validation for impurities, APIs
— Stability and release testing and excipients, for
more than
What to expect in this catalogue:
An introduction to Mikromol
How to read your Certificate of Analysis
2
3
1,000
API families
Contact details 7

Our reference standards:


Primary API and impurity reference
standards (in alphabetical order by API) 9
A to B A-1 to A-95
C to D A-95 to A-209
E to G A-209 to A-294
H to L A-294 to A-363
M to N A-363 to A-449
O to P A-449 to A-533
Q to S A-533 to A-592
T to Z** A-592 to A-675
**includes:
myo-Inositol and alpha-L-Rhamnose Monohydrate

Excipient reference standards 685


Elemental impurity standards
for ICH Q3D/USP <232> 698

Need any help?


Our technical team at mikromol@lgcgroup.com and our customer
service advisers across the globe are ready to answer your questions.
You can find the contact details for your local sales office here.

Phase separation during the liquid-liquid extraction


1 of Enalapril Maleate. (Impurity Imidazole, MM0015.02)
Our quality enables
your accuracy.

At Mikromol, we go beyond the standard.


Each aspect of our offering – knowledge,
competency, quality, scientific intellect and
transparency – is at the core of everything
we do. This is how we consistently and
competently deliver high-quality, globally
relevant pharmaceutical reference standards
that you can trust.

What ‘Mikromol quality’ means to us:


Producing to the highest Understanding your
standard. analytical needs.
M ikromol reference standards are T hrough direct interactions with our
produced to the highest quality, with customers and our expertise in the latest
the majority of analytical measurements scientific and regulatory developments,
performed under our ISO/IEC 17025 we are able to quickly adapt our
scope of accreditation, as well as a portfolio of reference standards to
leading range of products manufactured address your needs. We are committed
according to our ISO 17034 accreditation. to providing you with trusted solutions,
today and tomorrow.
We
 use the most advanced analytical
techniques to characterise our reference
standards, so that you can rely on the Providing expert support.
scientific integrity of the data contained
In LGC we combine experience with
in your Certificate of Analysis. Crystallisation of Metformin
continuous training to ensure that
Hydrochloride after
the latest knowledge and skills are removal of Methanol from
Ensuring confidence being applied to the production of the reaction mixture.

from characterisation Mikromol reference standards. (Impurity Cyanoguanidine,


MM0056.01)
to implementation. We
 are proud to connect with our
We use real-time stability testing and customers across a global network,
expiry date management to give you with dedicated local teams able to
confidence in your Mikromol reference support your reference standard
standards and ensure you receive decisions and the implementation of
your products as certified, ready for our products in your analytical testing.
your analysis.
Our heritage, our vision,
Safeguarding the integrity your guarantee.
of your reference standards. M ikromol is built upon more than 25
years of history in planning, developing,
Our state-of-the-art global logistics and producing, analysing, packaging and
distribution centre has experienced delivering high-quality reference
supply chain and export departments. standards to our customers around
This ensures fast delivery of Mikromol the world with speed and reliability.
products to our customers.

2
How to read your
Certificate of Analysis.
Every product you receive comes with a comprehensive,
multi-page Certificate of Analysis (CoA).

Each CoA provides a full description of the material to which it relates, as well
as a summary of the analyses undertaken during the characterisation process.

CoA Sections
General information | Additional product information | Assay | Purity | Identity |
Stability and homogeneity | Revision table

General information
1 
Q uality level
2 Product information
3 Assay value and
uncertainty
– F or ISO 17025 and
ISO 17034 certificates,
Certificate of Analysis ISO 17034 1 determined by an
accredited absolute
Reference Standard method (qNMR and/or
2 Product Name carbon titration)
Tramadol Hydrochloride
– F or ISO 9001 certificates,
Product Code Lot Number
MM0007.00-0250 G1010777 determined in the
CAS No. Appearance majority of the cases
36282-47-0 white solid
Mol. Weight Melting Point (DSC) by 100%-method (no
299.84 181°C
uncertainty given for
Mol. Formula Long-term Storage
C16H25NO2 HCl 2 to 8°C, dark ISO 9001)
4 Intended use: For ISO 17034
products and products
3 Assay1 “as is” Uncertainty2 U manufactured according
99.4% 0.6%
to ISO 17025
Intended Use: Use for identification and quantification. The assay is verified by a second testing method.
Due to the homogeneity studies, the minimum amount of sample to be used is 10mg.
4 5 Date of shipment (DOS)
and validity of the product
Date of shipment: 02 Sep 2019 5 based on DOS
Producer confirms that this reference material (RM) meets the specification detailed on this Certificate for two years from the date of shipment,
provided the substance is stored under the recommended conditions unopened in the original container.
6 Release information
7 Information about
Release by: Date of Release:
6 accreditations and
Dr. S. Schröder Luckenwalde, 21 Aug 2019 Product Release manufacturer
1
Calibration and verification were carried out using standards traceable to SI-units. The value is expressed on an “as is” basis.

2
The uncertainty “U” is the expanded uncertainty of the testing method for the assigned value estimated in accordance with
the Guide to the Expression of Uncertainty in Measurement (GUM). It corresponds to a level of confidence of about 95%.
Coverage factor k =2.

Organisation certified to ISO 9001 | DQS 102448 and GMP (EXCiPACT) RM Producer: Page 1/8
7 Production accredited to ISO 17034 | DAkkS D-RM-14176-01-00 | Test methods LGC GmbH
for characterization are accredited to ISO/IEC 17025 | DAkkS D-PL-14176-01-00 Louis-Pasteur-Str. 30
D-14943 Luckenwalde
Germany
www.lgcstandards.com

D-RM-14176-01-00

3
How to read your Certificate
of Analysis (continued).

8 Important Product Information

This RM is intended for laboratory use only and is not suitable for human or animal consumption.

This RM conforms to the characteristics of a primary standard as described in the ICH guidelines. The values
quoted in this Certificate of Analysis are the producer’s best estimate of the true values within the stated
uncertainties and based on the techniques described in this Certificate of Analysis. The production of this
RM was undertaken in accordance with the requirements of ISO 17034. The identity is verified by data from
international scientific literature.

9 Storage and Handling

Before usage of the RM, it should be allowed to warm to room temperature. No drying is required, as assigned
values are already corrected for the content of water and other volatile materials.

10 Further content

Assigned value

Identity

Stability and homogeneity

Revision table Additional product


information
8 Confirmation of primary
standard status for
standards manufactured
according to ISO 17025 and
ISO 17034
9 Storage and handling
recommendations
Assigned Value
11 Assay “as is”: 99.43%; U = 0.57% 10 Content of the CoA (varies
The assay “as is” is assessed by quantitative NMR spectroscopy and is equivalent to the assay based on the depending on the product
not-anhydrous and not-dried substance. The assay is verified by 100% method (mass balance). The verifying
result lies inside our acceptance criteria, i.e. less than 1.0 % difference to assay assigning technique. quality level)
For quantitative applications, use the assay as a calculation value on the “as is basis”. The uncertainty of the
assay can be used for estimation/calculation of measurement uncertainty.

Method 1: Value assigning technique - quantitative NMR spectroscopy

Conditions 400 MHz, CDCl3


Assay Section
Internal
GermanyStandard 2,3,5,6-Tetrachloro-1-nitrobenzene (certified reference
LGC GmbH, Louis-Pasteur-Str. 30, D-14943 Luckenwalde,
MM0007.00-0250 Lot number 110258
Page 2/8
material), signal 7.6 – 8.00 ppm, 1H 11 Assay result and details
Results (mass fraction, n=6) 99.43%; U=0.57% about assay assigning
Quantitative NMR spectrum technique. For ISO 17034
products and products
manufactured according
to ISO 17025 this will be
an ISO 17025-accredited
absolute method. For ISO
9001 products the assay
will usually be assigned by
mass balance calculated
from the values given in the
purity section
12 Details about the verifying
Method 2: Value verifying technique - 100% method assay for ISO 17034
100% method (mass balance) with
chromatographic purity by HPLC
products and products
Result 99.86% manufactured according
to ISO 17025. This assay
12 The calculation of the 100% method follows the formula:

Assay (%) = (100% - volatile contents (%)) *


Purity (%) confirms the result of the
100%
Volatile contents are considered as absolute contributions and purity is considered as relative contribution.
absolute method and is
Inorganic residues are excluded by additional tests.
assessed by a second,
independent method,
LGC GmbH, Louis-Pasteur-Str. 30, D-14943 Luckenwalde, Germany
MM0007.00-0250 Lot number G1010777
Page 3/8
usually mass balance
calculated from the values
given in the purity section

4
How to read your Certificate
of Analysis (continued).

13 Purity
Purity by High Performance Liquid Chromatography (HPLC)

HPLC Conditions:

Column Hypersil Gold C18, 5µm, 150 x 4.6mm

Column temperature 40°C

Detector DAD, 210nm

Injector Auto 5µl; 0.1631mg/ml in Water/Acetonitrile 50/50 (v/v)

Flow rate 1.0ml/min,

Phase A Water, 0.1% H3PO4

Phase B Acetonitrile, 0.1% H3PO4

Gradient Program 0-9min A/B 85/15


9-12min A/B to 50/50
12-14min A/B to 85/15
14-24min A/B 85/15 (v/v)

HPLC chromatogram and peak table

Purity section
13 Organic purity is usually
assessed by HPLC or GC.
Conditions, chromatogram
and area report are
displayed
Area Percent Report - Sorted by Signal 14 Volatile content: Water
Pk # Retention time Area Area%
content is determined
1 3.330 0.056 0.04
13 by Karl Fischer titration.
2 5.817 0.050 0.04

3 7.243 127.580 99.92


Residual solvents are
Totals 127.686 100.00 estimated by the use of
1
H-NMR or determined by
The content of the analyte was determined as ratio of the peak area of the analyte and the cumulative areas of
the purities, added up to 100 %. System peaks were ignored in calculation. GC/headspace techniques.
Result
LGC GmbH, Louis-Pasteur-Str. 30, D-14943 Luckenwalde, (n=6)
Germany 99.93%; U=0.19% Page 4/8 Alternatively the combined
MM0007.00-0250 Lot number 110258
volatile content is
14 Volatile content determined by LOD
Loss on drying

Method 105 °C to constant mass, EP 8.7 (2.2.32) 15 Inorganic residues are


Result (n=3) 0.07 %; SD = 0.01 %* excluded by either the
results of elementary
Inorganic residues analysis or by sulphated
Method: Sulphated ash, EP 8.7, chapter 2.4.14* ash for ISO 17034 products
According to the available data, the presence of inorganic impurities in the reference substance other than and products manufactured
those detectable by sulphated ash is highly unlikely. Inorganic residues can be excluded by results of the
15 sulphated ash. Therefore, no assay correction was performed for inorganic impurities. according to ISO 17025
*not accredited testing method

LGC GmbH, Louis-Pasteur-Str. 30, D-14943 Luckenwalde, Germany Page 5/8


MM0007.00-0250 Lot number G1010777

5
How to read your Certificate
of Analysis (continued).

Identity
The identity is assessed by ISO/IEC 17025 accredited testing methods.

Method Conditions Result


16
H-NMR
1
Conditions: 400 MHz, CDCl3 Structure confirmed

H-NMR Spectrum in CDCl3


1

Method Conditions Result


17 MS 3.5 KV ESI+; capillary temperate 269 °C, Structure confirmed
Theoretical value: 264.19581

264.19545
Identity section
16 
1
H-NMR spectra
17 MS spectra
Rel. Intensity (%)

18 IR spectra

Stability and homogeneity

Method Conditions Result


19 Stability and homogeneity
18 IR Attenuated Total Reflection Fourier Transform Structure confirmed statement: Included as
Infrared (ATR-FTIR) Spectroscopy
mandatory information with
LGC GmbH, Louis-Pasteur-Str. 30, D-14943 Luckenwalde, Germany
MM0007.00 Lot number 110258
Page 6/8 ISO 17034 products only

Revision table
20 Record of changes
that have been made
to the CoA

19 Stability and Homogeneity


The assessment of stability indicates no significant instability. The given validity period is based on this
data. This is backed up by additional stability testing and historical data over the range of several years.
RM quality is controlled by regularly performed quality control tests (re tests). Homogeneity assured by
qualifi ed process of preparation and verifi ed by homogeneity testing.

LGC GmbH, Louis-Pasteur-Str. 30, D-14943 Luckenwalde, Germany Page 7/8


MM0007.00 Lot number 110258
20 Revision table
Revision Date Reason for Revision

00 20 Aug 2019 Release of the Certificate of Analysis - initial version

Product warranties for the RM are set out in the terms and conditions of purchase.

LGC GmbH, Louis-Pasteur-Str. 30, D-14943 Luckenwalde, Germany Page 8/8


MM0007.00-0250 Lot number G1010777

6
worldwide

13

8 18 12 14
5
4 6 15
19 9 2
17
10

3
11

1 16

1 Brazil 8 Ireland 15 Romania


LGC does not guarantee availability and
T +55 12 3302 5880 T +44 (0)20 8943 8480 T +40 364 116890 reserves the right to discontinue any product.
E bz@lgcstandards.com E uksales@lgcstandards.com E ro@lgcstandards.com LGC does not accept liability for any loss that
is caused by inaccurate customer selection,
2 Bulgaria 9 Italy 16 South Africa product information or inappropriate use
T +359 (0)2 971 4955 T +39 02 22476412 T +27 (0)11 466 4321 of a product. Unless otherwise stated all
E bg@lgcstandards.com E it@lgcstandards.com E sales.za@lgcgroup.com trademarks are the property of LGC or its
affiliated group companies. No part of this
3 China 10 Korea 17 Spain publication may be reproduced or transmitted
T +86 400 9216156 T +82 10 7115 4577 T +34 (0)93 308 4181 in any form or by any means, electronic or
E info.china@lgcgroup.com E yong-jae.joo@lgcgropup.com E es@lgcstandards.com mechanical, including photocopying, recording
or any retrieval system, without the written
4 France 11 Middle East 18 UK reference materials permission of the copyright holder.
T +33 (0)3 88 04 82 82 T +49 (0) 281 9887 0 T +44 (0)20 8943 8480
E fr@lgcstandards.com E fr@lgcstandards.com E uksales@lgcstandards.com
Sales Office
5 Germany 12 Netherlands 19 USA + Canada Distributor
T +49 (0)281 9887 0 T +49 (0)281 9887 250 T +1 (603) 622 7660
E de@lgcstandards.com E nl@lgcstandards.com E lgcusa@lgcgroup.com

6 Hungary 13 Nordic Countries Export queries


T +40 364 116890 T +49 (0)281 9887 0 T +49 (0) 281 9887 250
E ro@lgcstandards.com E de@lgcstandards.com E global.sales@lgcgroup.com

7 India 14 Poland
T +91 9082974025 T +48 22 751 31 40
E india@lgcgroup.com E pl@lgcstandards.com

7
Our reference standards

Primary API and impurity


reference standards.

Our primary API reference standards are manufactured according to


ISO/IEC 17025 and an increasing number are accredited to ISO 17034.
All come with a detailed Certificate of Analysis, which includes identity For further guidance on
checks by several qualitative techniques. impurities please read the
relevant ICH documentation
available on ICH.org
Assay information is provided by an ISO/IEC 17025-accredited
absolute technique, and the assay is confirmed by a second ICH Q3A (R1)
independent method, usually mass balance. Impurities in New Drug
Substances
ICH Q3B (R2)
Limit and threshold values are required by official bodies as well as Impurities in New Drug Products
by legislation to detect, identify, quantify and qualify impurities in ICH Q3C (R5)
accordance with ICH Guidelines. Impurities: Guideline for
Residual Solvents
Mikromol impurity standards are high-quality materials, which include ICH Q3D
Impurities: Guideline for
a Certificate of Analysis containing detailed identity information, as Elemental Impurities
well as an assay value determined by mass balance or by an ISO/IEC
17025-accredited absolute technique, such as qNMR or C-titration.

It’s easy to order at:

lgcstandards.com/mikromol

Technical questions?
mikromol@lgcgroup.com

View your local office here

Formation of Omeprazole Sulphone by


oxidative degradation of Omeprazole.
(Imp. D (EP): 5-Methoxy-2-[[(4-
methoxy-3,5-dimethylpyridin-2-yl)
methyl]sulphonyl]-1H-benzimidazole
8 (Omeprazole Sulphone), MM0095.05)
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Abacavir Sulfate
NH

N
N O O

MM3249.00 Abacavir Sulfate 188062-50-2 250mg H 2N N N HO


S
OH

OH
2

N H2
Impurity C (EP): [(1S,4R)-4-(2,6-Diamino-9H-purin-9-yl) N
N

cyclopent-2-enyl]methanol H 2N N N

Related compound A (USP): [4-(2,6-diamino-9H-purin-9-yl)


MM3249.01 124752-25-6 100mg
cyclopent-2-enyl]methanol OH

N H2
Impurity C (EP): [(1S,4R)-4-(2,6-Diamino-9H-purin-9-yl) N
N

MM3249.01- cyclopent-2-enyl]methanol H 2N N N

Related compound A (USP): [4-(2,6-diamino-9H-purin-9-yl)


124752-25-6 25mg
0025
cyclopent-2-enyl]methanol OH

NH

N
MM3249.10- Impurity E (EP): [(1R,3S)-3-[2-Amino-6-(cyclopropylamino)- N
208762-35-0 25mg H2 N N N
0025 9H-purin-9-yl]cyclopentyl]methanol
OH

NH
Impurity F (EP): 6-(Cyclopropylamino)-9-[(1R,4S)-4-[[(1,1- N
N
MM3249.11-
dimethylethyl)oxy]methyl]cyclopent-2-enyl]-9H-purine-2- 1443421-68-8 25mg H 2N N N

0025
amine (Abacavir tert-Butyl Ether) O

[(1S,4R)-4-(2-Amino-6-chloro-9H-purin-9-yl)cyclopent-2-enyl] Cl

N
N
MM3249.02- methanol Hydrochloride H 2N N N HCl
172015-79-1 25mg
0025 Related compound C (USP): [(1S,4R)-4-(2-amino-6-chloro-
OH
9H-purin-9-yl)cyclopent-2-enyl]methanol
NH2

MM3249.04- N N
2,6-Diaminopurine 1904-98-9 100mg
0100 N
H 2N N
H

Cl
MM3249.05- NH2
4,6-Dichloropyrimidine-2,5-diamine 55583-59-0 25mg N
0025
H 2N N Cl

NH

N
N
MM3249.06- H 2N N N
O-Acetylabacavir 178456-36-5 25mg
0025
O
O

Cl
H
N O
MM3249.12- N
4,6-Dichloro-2,5-diformamidopyrimidine 116477-30-6 25mg HN N Cl
0025
O

Cl
H
N O
MM3249.16- O N
N-(4,6-Dichloro-5-formamidopyrimidin-2-yl)acetamide 136470-91-2 25mg
0025 N N Cl
H

Cl
H
N O
O N
MM3249.17- N-[4-Chloro-5-formamido-6-[[(1R,4S)-4-(hydroxymethyl) N N NH
136522-32-2 25mg H
0025 cyclopent-2-en-1-yl]amino]pyrimidin-2-yl]acetamide
OH

NH
MM3249.18-
2-Amino-6-(cyclopropylamino)-9H-purine 120503-69-7 25mg N
N
0025
H 2N N N
H

Cl
H
MM3249.19- N O
N
N-(2-Amino-4,6-dichloropyrimidin-5-yl)formamide 171887-03-9 25mg
0025 H2 N N Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-1
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N
HN
MM3249.20- N
(-)-Carbovir 120443-30-3 25mg H 2N N

0025
OH

Abemaciclib
F
N N N
F N
MM3932.00- N N
H

Abemaciclib 1231929-97-7 250mg N


N
0250

Abiraterone
N

MM3294.00 Abiraterone 154229-19-3 250mg H

H H
HO

Abiraterone Acetate
N

MM3504.00 Abiraterone Acetate 154229-18-2 250mg H


O
H H
O

MM3294.00 Abiraterone 154229-19-3 250mg H

H H
HO

H
MM3504.01 16-Dehydropregnenolone Acetate 979-02-2 100mg O
H H
O

MM3504.01- H
16-Dehydropregnenolone Acetate 979-02-2 25mg O
0025 H H
O

MM3504.02-
Diethyl(3-pyridinyl)borane 89878-14-8 25mg
0025 B

O O

O S F
Androsta-5,16-diene-3 ,17-diol 3-Acetate 17- F
F
H
MM3504.04 115375-60-5 100mg O
Trifluoromethanesulfonate H H
O

O O

O S F
MM3504.04- Androsta-5,16-diene-3 ,17-diol 3-Acetate 17- F
F
H
115375-60-5 25mg O
0025 Trifluoromethanesulfonate H H
O

Acamprosate Calcium
Impurity A (EP): 3-Aminopropane-1-sulfonic Acid
O O
(Homotaurine)
MM3407.01 H 2N S
Related compound A (USP): 3-aminopropane-1-sulfonic
3687-18-1 100mg OH

acid
Impurity A (EP): 3-Aminopropane-1-sulfonic Acid
O O
MM3407.01- (Homotaurine)
H 2N S
Related compound A (USP): 3-aminopropane-1-sulfonic
3687-18-1 25mg OH
0025
acid

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-2
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Acarbose
HO HO HO

MM0916.00- OH OH
O
OH
O
OH
O
OH
Acarbose 56180-94-0 250mg OH N O O
0250 H
OH OH OH OH

Acebutolol Hydrochloride
O
OH
H
MM0435.00- O N
Acebutolol Hydrochloride 34381-68-5 250mg O

N HCl
0250 H

MM0435.01- Impurity A (EP): N-[3-Acetyl-4-[(2RS)-oxiran-2- O


O
O
28197-66-2 25mg
0025 ylmethoxy]phenyl]butanamide N
H

Impurity B (EP) as Hydrochloride: N-[3-Acetyl-


4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]- O
OH
propoxy]phenyl]acetamide Hydrochloride O
O
H
N

(Diacetolol Hydrochloride)
MM0435.02 73899-76-0 100mg HCl
N
H

Related compound B (USP): N-3-Acetyl-4-[2-hydroxy-3-


(isopropylamino)propoxy]phenylacetamide
Impurity B (EP) as Hydrochloride: N-[3-Acetyl-
4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]- O
OH
MM0435.02- propoxy]phenyl]acetamide Hydrochloride O
O
H
N

(Diacetolol Hydrochloride)
73899-76-0 25mg HCl
0025 N
H

Related compound B (USP): N-3-Acetyl-4-[2-hydroxy-3-


(isopropylamino)propoxy]phenylacetamide
Impurity C (EP): N-(3-Acetyl-4-hydroxyphenyl)- O

butanamide O
OH

Related compound A (USP): N-(3-acetyl-4-hydroxyphenyl)


MM0435.03 40188-45-2 100mg
N
H
butanamide
Impurity C (EP): N-(3-Acetyl-4-hydroxyphenyl)- O

MM0435.03- butanamide O
OH

Related compound A (USP): N-(3-acetyl-4-hydroxyphenyl)


40188-45-2 25mg
0025 N
H
butanamide

MM0435.04- Impurity D (EP) as Dihydrochloride: 1-[5-Amino-2- O


OH
H

[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]- n/a 25mg


H 2N
O N HCl
2

0025 propoxy]phenyl]ethanone Dihydrochloride

MM0435.05- Impurity E (EP) as Hydrochloride: N-[4-[(2RS)-2- O


OH
H
N

Hydroxy-3-[(1-methylethyl)amino]propoxy]- n/a 25mg O

N HCl
H
0025 phenyl]butanamide Hydrochloride
O

Impurity F (EP): N-[3-Acetyl-4-[(2RS)-2,3-


OH
MM0435.06- O
O OH

96480-91-0 25mg
0025 dihydroxypropoxy]phenyl]butanamide N
H

Impurity G (EP): N,N'-[[(1-Methylethyl)imino]- O O

bis[(2-hydroxypropane-1,3-diyl)oxy(3-
OH OH
MM0435.07- O N O

n/a 25mg
acetyl-1,4-phenylene)]]dibutanamide
HN NH

0025 O O

(Acebutolol Biamine)

MM0435.08- Impurity H (EP): N,N'-[(2-Hydroxypropane-1,3- O

O
OH
O
O

diyl)bis[oxy(3-acetyl-1,4-phenylene)]]di- n/a 25mg HN NH


0025 butanamide O O

Impurity I (EP): N-[3-Acetyl-4-[(2RS)-3-


MM0435.09- (ethylamino)-2-hydroxypropoxy]- O
OH
H
O N

phenyl]butanamide 441019-91-6 25mg O

N
0025 Related compound I (USP): N-3-Acetyl-4-[3-(ethylamino)-2- H

hydroxypropoxy]phenylbutyramide

MM0435.10- Impurity J (EP) as Hydrochloride: N-[3-Acetyl-4- O


OH
H
O N

[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]- 57898-79-0 25mg O

N HCl
0025 propoxy]phenyl]propanamide Hydrochloride H

MM0435.11- Impurity K (EP) as Hydrochloride: N-[3-Butanoyl- O


OH
H
O N

4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]- 57898-71-2 25mg O

N HCl
0025 propoxy]phenyl]butanamide Hydrochloride H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-3
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
MM0877.16-
2-Etoxyacetophenone 2142-67-8 100mg
0100
O

Acecarbromal
O O O
Br
MM1724.00 Acecarbromal 77-66-7 50mg N
H
N
H

Aceclofenac
O
O
OH
O
MM0181.00 Aceclofenac 89796-99-6 250mg NH
Cl Cl

OH

O
MM0006.20- Impurity A (EP): [2-[(2,6-Dichlorophenyl)- NH
15307-86-5 250mg
0250 amino]phenyl]acetic Acid (Diclofenac) Cl Cl

Impurity B (EP): Methyl [2-[(2,6-Dichloro- O


NH
MM0006.10 phenyl)amino]phenyl]acetate 15307-78-5 100mg Cl Cl
(Methyl Ester of Diclofenac)

Impurity B (EP): Methyl [2-[(2,6-Dichloro- O


MM0006.10- NH
phenyl)amino]phenyl]acetate 15307-78-5 25mg Cl Cl
0025 (Methyl Ester of Diclofenac)

Impurity C (EP): Ethyl [2-[(2,6-Dichloro- O


NH
MM0006.11 phenyl)amino]phenyl]acetate 15307-77-4 100mg Cl Cl
(Ethyl Ester of Diclofenac)

Impurity C (EP): Ethyl [2-[(2,6-Dichloro- O


MM0006.11- NH
phenyl)amino]phenyl]acetate 15307-77-4 25mg Cl Cl
0025 (Ethyl Ester of Diclofenac)

O
O
Impurity D (EP): Methyl [[[2-[(2,6-Dichloro- O
O
MM0181.01 phenyl)amino]phenyl]acetyl]oxy]- 139272-66-5 100mg NH
Cl Cl
acetate (Methyl Ester of Aceclofenac)

O
O
Impurity D (EP): Methyl [[[2-[(2,6-Dichloro- O
MM0181.01- O
phenyl)amino]phenyl]acetyl]oxy]- 139272-66-5 25mg NH
Cl Cl
0025 acetate (Methyl Ester of Aceclofenac)
O

Impurity E (EP): Ethyl [[[2-[(2,6-Dichloro- O


O
O
MM0181.02 phenyl)amino]phenyl]acetyl]oxy]- 139272-67-6 100mg Cl
NH
Cl
acetate (Ethyl Ester of Aceclofenac)
O

MM0181.02- Impurity E (EP): Ethyl [[[2-[(2,6-Dichloro- O


O
O
phenyl)amino]phenyl]acetyl]oxy]- 139272-67-6 25mg Cl
NH
Cl
0025 acetate (Ethyl Ester of Aceclofenac)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-4
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0181.03- Impurity F (EP): Benzyl [[[2-[(2,6-Dichloro- O


O
O
phenyl)amino]phenyl]acetyl]oxy]acetate 100499-89-6 25mg Cl
NH
Cl
0025 (Benzyl Ester of Aceclofenac)
O

Impurity G (EP): [[[[[2-[(2,6-Dichlorophenyl)- O


O
OH

O O
MM0181.04 amino]phenyl]acetyl]oxy]acetyl]oxy]acetic 1215709-75-3 100mg Cl
NH
Cl

Acid (Acetic Aceclofenac)


O

MM0181.04- Impurity G (EP): [[[[[2-[(2,6-Dichlorophenyl)- O


O
OH

O O
amino]phenyl]acetyl]oxy]acetyl]oxy]acetic 1215709-75-3 25mg Cl
NH
Cl
0025 Acid (Acetic Aceclofenac)
O O

Impurity H (EP): [[[[[[[2-[(2,6-Dichlorophenyl)- O


O
O
OH
O O
MM0181.05 amino]phenyl]acetyl]oxy]acetyl]oxy]acetyl]- 1216495-92-9 50mg Cl
NH
Cl

oxy]acetic Acid (Diacetic Aceclofenac)

O
N
Impurity I (EP): 1-(2,6-Dichlorophenyl)-1,3-
MM0006.01
dihydro-2H-indol-2-one
15362-40-0 100mg Cl Cl

O
N
MM0006.01- Impurity I (EP): 1-(2,6-Dichlorophenyl)-1,3-
15362-40-0 25mg Cl Cl
0025 dihydro-2H-indol-2-one

Isopropyl [2-[(2,6-Dichlorophenyl)- NH
O

MM0181.06 amino]phenyl]acetate (Isopropyl Ester 66370-79-4 100mg Cl Cl


of Diclofenac)

MM0181.06- Isopropyl [2-[(2,6-Dichlorophenyl)- NH


O

amino]phenyl]acetate (Isopropyl Ester 66370-79-4 25mg Cl Cl


0025 of Diclofenac)

O
O
O
O
NH
MM0181.11 Aceclofenac Isopropyl Ester n/a 100mg Cl Cl

O
O
O
MM0181.11- NH
O
Aceclofenac Isopropyl Ester n/a 25mg Cl Cl
0025

O OH
O
O
O
O
MM0181.12- Cl
NH
Cl
O
O OH
O
Aceclofenac 1,3-Butylene Glycol Esters (Mixture of Isomers) n/a 25mg Cl
NH
Cl
0025
O
O
O
O OH
NH O
MM0181.14- Cl Cl O
O
OH

Aceclofenac 1,2-Propylene Glycol Esters (Mixture of Isomers) n/a 25mg NH


O

0025 Cl Cl

Acefylline
O
O
OH
N
MM1727.00 Acefylline 652-37-9 250mg N

O N N

Acemetacin
O

O O
OH
N

MM1728.00 Acemetacin 53164-05-9 100mg O

O
Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-5
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0063.03 Impurity A (EP): 4-Chlorobenzoic Acid 74-11-3 100mg OH

Cl

O
MM0063.03- OH
Impurity A (EP): 4-Chlorobenzoic Acid 74-11-3 25mg
0025
Cl

O
OH
N
Impurity B (EP): [1-(4-Chlorobenzoyl)-5-methoxy-2- O
MM0584.00 53-86-1 500mg Cl
methylindol-3-yl]acetic Acid (Indometacin)
O

O O
O
MM1728.01- N
O
Acemetacin Methyl Ester 681838-84-6 25mg
0025 Cl
O

O O
O
MM1728.02- N
O
Acemetacin Ethyl Ester 76812-43-6 25mg
0025 Cl
O

O
O O
O
MM1728.03- N
O
Acemetacin Isopropyl Ester n/a 25mg
0025 Cl
O

O OH
O O
O
N
O

O
MM1728.05- Cl

Acemetacin 1,3-Butylene Glycol Esters (Mixture of Isomers) n/a 25mg O


O O
0025 O OH
N
O

O
Cl

O O
O
MM1728.06- N
O OH
Acemetacin 2,3-Butylene Glycol Ester n/a 25mg
0025 O
Cl

O O
O
N
O OH

O
MM1728.07- Cl

Acemetacin 1,2-Propylene Glycol Esters (Mixture of Isomers) n/a 25mg O

O O OH
0025 O
N
O

O
Cl

O O
O OH
N
O OH

MM1728.08- Cl
O O
OH

Acemetacin 1,2,3-Propanetriol Esters (Mixture of Isomers) n/a 25mg O O OH


O
N
0025 O

O
Cl

O
O
O
MM1728.09- (2-Methoxy-2-oxoethyl) 2-(5-Methoxy-2-methyl-1H-indol-3-yl) HN
O
n/a 25mg
0025 acetate
O

MM1728.10- HN
O
Methyl 2-(5-Methoxy-2-methyl-1H-indol-3-yl)acetate 7588-36-5 25mg
0025
O

O
O
O
MM1728.11- (2-Ethoxy-2-oxoethyl) 2-(5-Methoxy-2-methyl-1H-indol-3-yl) HN
O
n/a 25mg
0025 acetate
O

O
MM1728.12- HN
O
Ethyl 2-(5-Methoxy-2-methyl-1H-indol-3-yl)acetate 17536-38-8 25mg
0025
O

O
O
O
MM1728.13- (2-Isopropoxy-2-oxoethyl) 2-(5-Methoxy-2-methyl-1H-indol-3- HN
O
n/a 25mg
0025 yl)acetate
O

Acenocoumarol
O
+
O O N
O

MM1205.00 Acenocoumarol 152-72-7 250mg


OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-6
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Acepromazine Maleate
O
N N
OH
MM0927.00 Acepromazine Maleate 3598-37-6 250mg S
OH

O
O

Acesulfame Potassium
O NH2
MM1093.01 Impurity A (EP): 3-Oxobutanamide (Acetylacetamide) 5977-14-0 100mg
O

Acetaminophen, see Paracetamol

Acetaminosalol
H
N
O

MM1609.00 Acetaminosalol 118-57-0 250mg O


O

OH

Acetazolamide
O O
H
S S N
MM0648.00 Acetazolamide 59-66-5 500mg H2 N
N N O

H
Impurity A (EP): N-(5-Chloro-1,3,4-thiadiazol-2- Cl S N
MM0648.04 60320-32-3 50mg
yl)acetamide N N O

H
S N
MM0648.01 Impurity B (EP): N-(1,3,4-Thiadiazol-2-yl)acetamide 5393-55-5 50mg
N N O

Impurity D (EP): 5-Amino-1,3,4-thiadiazole-2- O O


sulfonamide S S NH2
H 2N
Related compound D (USP): 5-Amino-1,3,4-thiadiazole-2-
MM0648.02 14949-00-9 100mg
N N
sulfonamide
Impurity D (EP): 5-Amino-1,3,4-thiadiazole-2- O O
MM0648.02- sulfonamide S S NH2
H 2N
Related compound D (USP): 5-Amino-1,3,4-thiadiazole-2-
14949-00-9 25mg
0025 N N
sulfonamide

Acetildenafil
O

N O HN N

MM1269.00 Acetildenafil 831217-01-7 100mg N


N
N

Acetomenaphthone
O

MM1730.00 Acetomenaphthone (Menadiol Diacetate) 573-20-6 250mg

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-7
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Acetophenazine Maleate
O
N N

MM1725.00 Acetophenazine Maleate 5714-00-1 100mg S N


OH

O
OH
OH

O 2

Acetylcysteine
O

HS OH
MM0024.00 N-Acetyl-L-cysteine 616-91-1 500mg HN

N H2 O

MM0024.03 Impurity A (EP): L-Cystine 56-89-3 100mg HO S


S OH
O N H2

MM0024.02 Impurity B (EP): L-Cysteine 52-90-4 100mg HS OH


NH2

NH O

MM0024.04 Impurity C (EP): N,N'-Diacetyl-L-cystine 5545-17-5 100mg HO S


S OH
O HN

NH O
MM0024.04-
Impurity C (EP): N,N'-Diacetyl-L-cystine 5545-17-5 25mg HO S
S OH

0025 O HN

O O

S OH
MM0024.01 Impurity D (EP): N,S-Diacetyl-L-cysteine 18725-37-6 100mg HN

O O

MM0024.01- S OH
Impurity D (EP): N,S-Diacetyl-L-cysteine 18725-37-6 25mg HN
0025
O

O
Sodium 2-Methyl-4,5-dihydro-1,3-thiazol- N
O
Na
+

4-carboxylate
MM0024.05 15058-19-2 100mg
S

O
MM0024.05- Sodium 2-Methyl-4,5-dihydro-1,3-thiazol- N
O
Na
+

4-carboxylate
15058-19-2 25mg
0025 S

HS OH
MM0024.06 N-Propionyl-L-cysteine 2885-79-2 100mg HN

MM0024.06- HS OH
N-Propionyl-L-cysteine 2885-79-2 25mg HN
0025
O

HS O
MM0024.08 N-Acetyl-L-cysteine Methyl Ester 7652-46-2 100mg HN

MM0024.08- HS O
N-Acetyl-L-cysteine Methyl Ester 7652-46-2 25mg HN
0025
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-8
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HS O
MM0024.09 N-Acetyl-L-cysteine Ethyl Ester 59587-09-6 100mg HN

MM0024.09- HS O
N-Acetyl-L-cysteine Ethyl Ester 59587-09-6 25mg HN
0025
O

MM0024.10- HS O
N-Acetyl-L-cysteine Isopropyl Ester 73255-51-3 25mg HN
0025
O

NH O
MM0024.11- O S
N,N'-Diacetyl-L-cystine Dimethyl Ester 32381-28-5 25mg S O
O HN
0025
O

Acetylsalicylic Acid (Aspirin)


O

OH
MM0133.00-
Acetylsalicylic Acid 50-78-2 250mg
0250 O

O
MM0045.01-
Impurity A (EP): 4-Hydroxybenzoic Acid 99-96-7 250mg OH
0250
HO

O O

Impurity B (EP): 4-Hydroxybenzene-1,3- HO OH


MM0045.02 636-46-4 100mg
dicarboxylic Acid (4-Hydroxyisophthalic Acid) OH

O O
MM0045.02- Impurity B (EP): 4-Hydroxybenzene-1,3- HO OH
636-46-4 25mg
0025 dicarboxylic Acid (4-Hydroxyisophthalic Acid) OH

O
MM0045.00- OH
Impurity C (EP): Salicylic Acid 69-72-7 250mg
0250
OH

OH O
Impurity D (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]- O O
MM0133.01 530-75-6 100mg
benzoic Acid (Acetylsalicylsalicylic Acid)
O

OH O
MM0133.01- Impurity D (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]- O O
530-75-6 25mg
0025 benzoic Acid (Acetylsalicylsalicylic Acid)
O

OH
MM0133.03- Impurity E (EP): 2-[(2-Hydroxybenzoyl)oxy]- O OH
552-94-3 250mg
0250 benzoic Acid (Salicylsalicylic Acid)
O

O O O
Impurity F (EP): 2-(Acetyloxy)benzoic Anhydride O
MM0133.02 1466-82-6 100mg
(Acetylsalicylic Anhydride) O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-9
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O O O
MM0133.02- Impurity F (EP): 2-(Acetyloxy)benzoic Anhydride O
1466-82-6 25mg
0025 (Acetylsalicylic Anhydride) O

OH
O

MM0133.04 2-(2,4-Dihydroxybenzoyl)benzoic Acid 2513-33-9 100mg OH

OH

OH
O
MM0133.04-
2-(2,4-Dihydroxybenzoyl)benzoic Acid 2513-33-9 25mg OH
0025

OH

O O

MM0133.08- HO OH
4-Acetoxyisophthalic Acid 5985-26-2 25mg O
0025
O

OH

O
MM0133.09-
Acetylsalicylsalicylsalicylic Acid 85531-16-4 25mg O O
0025 O O

MM0133.11 4-Acetoxybenzoic Acid 2345-34-8 100mg O OH

O
MM0133.11-
4-Acetoxybenzoic Acid 2345-34-8 25mg O OH
0025 O

O
MM0133.12 Methyl Acetylsalicylate 580-02-9 100mg
O

O
MM0133.12-
Methyl Acetylsalicylate 580-02-9 25mg
0025 O

O
MM0133.13 Ethyl Acetylsalicylate 529-68-0 100mg
O

O
MM0133.14 Isopropyl Acetylsalicylate 2224-88-6 50mg
O

O OH
O
MM0133.19- O
Hexanedioic Acid Mono-(2-carboxyphenyl) Ester 863985-44-8 25mg OH

0025 O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-10
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HO O
O

MM0133.20- O
O O

Hexanedioic Acid Bis-(2-carboxyphenyl) Ester 69638-07-9 25mg O


OH
0025
O
MM0045.15- OH
N
Salicyluric Acid 487-54-7 25mg H
0025 O
OH

N-Acetyltryptophan
H
N
NH2

MM1267.01 Impurity A (EP): Tryptophan 54-12-6 100mg OH

H
N
NH2
MM1267.01-
Impurity A (EP): Tryptophan 54-12-6 25mg OH
0025 O

H
N
Impurity D (EP): (S)-2-Amino-3-(5-hydroxy-
NH2
MM0172.03 1H-indol-3-yl)propanoic Acid (5-Hydroxy- 4350-09-8 100mg HO

tryptophan) O
OH

N-Acetyltyrosine
O
HO
HN
MM3571.00 N-Acetyltyrosine (N-Acetyl-L-Tyrosine) 537-55-3 250mg OH

Aciclovir (Acyclovir)
O

N
HN
MM0061.00 Aciclovir 59277-89-3 500mg N
OH

H2 N N
O

Impurity A (EP): 2-[(2-Amino-6-oxo-1,6-


dihydro-9H-purin-9-yl)methoxy]ethyl O

N
HN
MM0061.01 Acetate 102728-64-3 100mg H2 N N N
O
O

Related compound A (USP): 2-[(2-amino-6-oxo-1,6-dihydro- O

9H-purin-9-yl)methoxy]ethyl acetate
Impurity A (EP): 2-[(2-Amino-6-oxo-1,6-
MM0061.01- dihydro-9H-purin-9-yl)methoxy]ethyl O

N
HN
Acetate 102728-64-3 25mg H2 N N N
O
O
0025 Related compound A (USP): 2-[(2-amino-6-oxo-1,6-dihydro- O

9H-purin-9-yl)methoxy]ethyl acetate
O
H
Impurity B (EP): 2-Amino-1,7-dihydro-6H- HN
N
MM0061.02 73-40-5 100mg
purin-6-one (Guanine)
H 2N N N

Impurity C (EP): 2-Amino-7-[(2-hydroxy- O


O OH
N
MM0061.03 ethoxy)methyl]-1,7-dihydro-6H-purin- 91702-61-3 100mg HN

H 2N N N
6-one

MM0061.03- Impurity C (EP): 2-Amino-7-[(2-hydroxy- O


O OH
N
ethoxy)methyl]-1,7-dihydro-6H-purin- 91702-61-3 25mg HN

H 2N N N
0025 6-one
O
2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin- HN
N
O
MM0061.04
9-yl)methoxy]ethyl Benzoate
59277-91-7 100mg H2 N N N O
O

O
MM0061.04- 2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin- HN
N
O

9-yl)methoxy]ethyl Benzoate
59277-91-7 25mg H2 N N N O
0025 O

Impurity F (EP): N-[9-[(2-Hydroxyethoxy)-


methyl]-6-oxo-6,9-dihydro-1H-purin-2- O

N
O HN
MM0061.06 yl]acetamide 110104-37-5 100mg N N N
OH

Related compound F (USP): N-[9-[(2-Hydroxyethoxy) H O

methyl]-6-oxo-6,9-dihydro-1H-purin-2-yl]acetamide

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-11
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity F (EP): N-[9-[(2-Hydroxyethoxy)-


MM0061.06- methyl]-6-oxo-6,9-dihydro-1H-purin-2- O

N
O HN
yl]acetamide 110104-37-5 25mg N N N
OH

0025 Related compound F (USP): N-[9-[(2-Hydroxyethoxy) H O

methyl]-6-oxo-6,9-dihydro-1H-purin-2-yl]acetamide
Impurity G (EP): 2-[[(2-(Acetylamino)-6-
oxo-1,6-dihydro-9H-purin-9-yl]- O

N O
O HN
MM0061.07 methoxy]ethyl Acetate 75128-73-3 100mg N N N
O

Related compound G (USP): 2-[2-(Acetylamino)-6-oxo-1,6- H O

dihydro-9H-purin-9-yl]methoxyethyl acetate
Impurity G (EP): 2-[[(2-(Acetylamino)-6-
MM0061.07- oxo-1,6-dihydro-9H-purin-9-yl]- O

N O
O HN
methoxy]ethyl Acetate 75128-73-3 25mg N N N
O

0025 Related compound G (USP): 2-[2-(Acetylamino)-6-oxo-1,6- H O

dihydro-9H-purin-9-yl]methoxyethyl acetate
O
MM0061.08- 2-[[2-(Acetylamino)-6-oxo-1,6-dihydro- O HN
N
O
133186-23-9 25mg
0025 9H-purin-9-yl]methoxy]ethyl Benzoate N
H
N N
O
O

O O
MM0061.21- Impurity K (EP): 2,2'-[Methylenediimino]bis[9-[(2- HO
N
NH HN
N
OH
1797131-64-6 25mg O
N N N
H
N
H
N N
O
0025 hydroxyethoxy)methyl]1,9-dihydro-6H-purin-6-one]
Cl

MM0061.10- N
2,6-Dichloropurine N
5451-40-1 25mg
0025
Cl N N
H

N
O HN
MM0061.12 N2-Acetylguanine 19962-37-9 100mg
N N N
H H

N
MM0061.12- O HN
N2-Acetylguanine 19962-37-9 25mg
0025 N N N
H H

Acitretin
O

MM3427.00 Acitretin 55079-83-9 250mg O


OH

Impurity B (EP): Ethyl (2E,4E,6E,8E)-9-(4-Methoxy-2,3,6-


trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoate O

O
MM3076.00 (Etretinate) 54350-48-0 100mg O

Related compound B (USP): ethyl (all-E)-9-(4-methoxy-


2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoate

Acyclovir, see Aciclovir

Adapalene
O

MM0681.00-
Adapalene 106685-40-9 250mg
0250 OH

Impurity A (EP): 2,2'-Binaphthalene-6,6'- HO


O

dicarboxylic Acid
Related compound E (USP): 2,2'-binaphthyl-6,6'-
MM0681.03 932033-58-4 50mg
OH

dicarboxylic acid O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-12
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
Impurity C (EP): 1-(2-Methoxyphenyl)tricyclo-
[3.3.1.13,7]decane
Related compound C (USP): 2-(adamant-1-yl)
MM0681.01 43109-77-9 50mg
methoxybenzene

Impurity D (EP): 1,1'-[4,4'Bis(methoxy)biphenyl-3,3'- O

diyl]bis(tricyclo[3.3.1.13,7]decane)
Related compound D (USP): 4,4'-dimethoxy-3,3'-di
MM0681.02 932033-57-3 50mg
O

(adamant-1-yl)biphenyl
Br

Methyl 6-Bromo-2-naphthoate
MM0681.05 33626-98-1 100mg O
Related compound A (USP): Methyl 6-bromo-2-naphthoate
O

Br

MM0681.05- Methyl 6-Bromo-2-naphthoate


33626-98-1 25mg O
0025 Related compound A (USP): Methyl 6-bromo-2-naphthoate
O

Methyl 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoate O

(Adapalene Methyl Ester)


MM0681.06 106685-41-0 100mg
Related compound B (USP): Methyl 6-[3-(1-adamantyl)-4- O

O
methoxyphenyl]-2-naphthoate
Methyl 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoate O

MM0681.06- (Adapalene Methyl Ester)


106685-41-0 25mg
0025 Related compound B (USP): Methyl 6-[3-(1-adamantyl)-4- O

O
methoxyphenyl]-2-naphthoate

Adefovir Dipivoxil
N H2
O
N
N O
O
N P O
N O
O
MM3505.00 Adefovir Dipivoxil 142340-99-6 250mg
O

Adenine
NH2
H
N
MM1495.00 Adenine 73-24-5 250mg N

N N

Adenosine
N H2
N
N
MM0784.00- HO N
Adenosine 58-61-7 250mg N
O
0250

O HO H

NH2

Impurity A (EP) as Sulphate: 7H-Purin-6-amine N


N
HO
O
S OH
MM0784.01 321-30-2 100mg
Sulphate (Adenine Sulphate) N N
H 2
O

NH2
MM0784.01- Impurity A (EP) as Sulphate: 7H-Purin-6-amine N
N
HO
O
S OH
321-30-2 25mg
0025 Sulphate (Adenine Sulphate) N N
H 2
O

HN

Impurity F (EP): 1- -D-Ribofuranosylpyrimidine- HO O N


MM0784.02 58-96-8 100mg
2,4(1H,3H)-dione (Uridine) O

O HO H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-13
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HN

MM0784.02- Impurity F (EP): 1- -D-Ribofuranosylpyrimidine- HO O N


58-96-8 25mg
0025 2,4(1H,3H)-dione (Uridine) O

O HO H

O
N
HN

Impurity G (EP): 9- -D-Ribofuranosyl-1,9-dihydro- HO


N N
MM0784.03 58-63-9 100mg O
6H-purin-6-one (Inosine)

O HO H

O
N
HN

H2 N N N
Impurity H (EP): 2-Amino-9- -D-ribofuranosyl-
MM0784.04 118-00-3 100mg H O
1,9-dihydro-6H-purin-6-one (Guanosine) O

OH OH

O
N
HN

H2 N N N
MM0784.04- Impurity H (EP): 2-Amino-9- -D-ribofuranosyl-
118-00-3 25mg H O
0025 1,9-dihydro-6H-purin-6-one (Guanosine) O

OH OH

Adenosine 5'-Monophosphate Disodium Salt


NH2

N
N

N N

MM3619.00 Adenosine 5'-Monophosphate Disodium Salt 4578-31-8 250mg HO


O Na
+

HO
O O
P
O O

Adenosine 5'-Triphosphate Disodium Salt Trihydrate


N H2

N
N
+
N Na
N
2

MM3658.00 Adenosine 5'-Triphosphate Disodium Salt Trihydrate 51963-61-2 250mg HO


O

H 2O
3
HO
O O O OH
P P P
O O O O O OH

Adiphenine Hydrochloride
O
N

Adiphenine Hydrochloride
O HCl
MM1172.00 50-42-0 250mg

Adipic Acid
O
HO
MM1008.02 Adipic Acid 124-04-9 250mg OH
O

Adrenaline Tartrate (Epinephrine Bitartrate)


OH OH O
H

Adrenaline Tartrate
HO N HO
OH
MM0614.00 51-42-3 500mg HO O OH

OH
H
HO N
MM0614.02 L-Adrenaline 51-43-4 500mg
HO

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-14
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
H
MM0614.12- HO N HCl
DL-Adrenaline Hydrochloride 329-63-5 25mg
0025 HO

OH
H
HO N
MM0614.15 DL-Adrenaline 329-65-7 100mg
HO

OH
H
MM0614.15- HO N
DL-Adrenaline 329-65-7 25mg
0025 HO

Impurity B (EP) as Tartrate Monohydrate: (1R)-2-Amino-1- OH OH O


MM0785.00- HO N H2 HO
OH
(3,4-dihydroxyphenyl)ethanol Tartrate Monohydrate 108341-18-0 250mg HO
H2 O O OH
0250
(Noradrenaline Tartrate Monohydrate)
Impurity C (EP) as Hydrochloride: 1-(3,4-Di- O
H
HO N HCl
MM0614.13 hydroxyphenyl)-2-(methylamino)ethanone 62-13-5 100mg
Hydrochloride (Adrenalone Hydrochloride) HO

OH
(1R)-1-(3,4-Dihydroxyphenyl)-2- O S O
H
MM0614.01 methylaminoethanesulphonic Acid 78995-75-2 100mg HO N

(Adrenaline -Sulphonate) HO

OH
(1R)-1-(3,4-Dihydroxyphenyl)-2- O S O
H
MM0614.01-
methylaminoethanesulphonic Acid 78995-75-2 25mg HO N
0025 (Adrenaline -Sulphonate) HO

OH
OH

MM0262.06 4-Hydroxy-3-methoxymandelic Acid 55-10-7 100mg O


HO
O

OH
OH
MM0262.06-
4-Hydroxy-3-methoxymandelic Acid 55-10-7 25mg O
0025 HO
O

Afatinib Dimaleate
O N
O O
N
HN

MM3700.00 Afatinib Dimaleate 850140-73-7 250mg N


O
HN

F O
OH
OH

2
Cl

Agomelatine
H
N

MM3583.00 Agomelatine 138112-76-2 250mg O

N
MM3583.01 7-Methoxy-1-naphthaleneacetonitrile 138113-08-3 100mg
O

N
MM3583.01-
7-Methoxy-1-naphthaleneacetonitrile 138113-08-3 25mg
0025
O

Ajmaline
HO
H
H

MM3436.00 Ajmaline 4360-12-7 250mg N


OH

N
HH
H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-15
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Alanine
NH2
OH
MM0566.00 Alanine 56-41-7 500mg
O

O NH2
Impurity A (EP): (2S)-2-Aminobutanedioic Acid (Aspartic OH
MM0567.00 56-84-8 500mg HO
Acid) O

NH2
Impurity B (EP): (2S)-2-Aminopentanedioic Acid (Glutamic HO OH
MM1333.00 56-86-0 250mg
Acid) O O

Albendazole
O
H
N O
MM0382.00 Albendazole 54965-21-8 500mg N
N
H
S

H
Impurity A (EP): 5-(Propylsulphanyl)-1H- N
NH2
MM0382.01 80983-36-4 100mg
benzimidazol-2-amine S N

H
MM0382.01- Impurity A (EP): 5-(Propylsulphanyl)-1H- N
NH2
80983-36-4 25mg
0025 benzimidazol-2-amine S N

O
H
Impurity B (EP): Methyl [5-Propylsulphinyl)- N
N
O

MM0382.02 54029-12-8 100mg H


1H-benzimidazol-2-yl]carbamate S
O
N

O
H
MM0382.02- Impurity B (EP): Methyl [5-Propylsulphinyl)- N
N
O

54029-12-8 25mg H

0025 1H-benzimidazol-2-yl]carbamate S
O
N

O
H
Impurity C (EP): Methyl [5-Propylsulphonyl)- N
N
O

MM0382.03 75184-71-3 100mg H


1H-benzimidazol-2-yl]carbamate O
S
O
N

O
H
MM0382.03- Impurity C (EP): Methyl [5-Propylsulphonyl)- N
N
O

75184-71-3 25mg H
0025 1H-benzimidazol-2-yl]carbamate O
S
O
N

H
Impurity D (EP): 5-(Propylsulphonyl)-1H-benzimidazol-2- N
N H2
MM0382.04 80983-34-2 100mg
amine O
S
O
N

H
MM0382.04- Impurity D (EP): 5-(Propylsulphonyl)-1H-benzimidazol-2- N
N H2
80983-34-2 25mg
0025 amine O
S
O
N

O
H
Impurity E (EP): Methyl (1H-Benzimidazol-2- N O
MM2500.00 10605-21-7 100mg N
yl)carbamate (Carbendazim) N
H

Impurity G (EP): Methyl N-(5-Chloro-1H-benzimidazol-2-yl) H


O
N O
MM0518.04 carbamate (Methyl (5-Chloro-1H-benzimidazol-2-yl) 20367-38-8 100mg N
H
N
carbamate) Cl

Impurity G (EP): Methyl N-(5-Chloro-1H-benzimidazol-2-yl) H


O
MM0518.04- N O
carbamate (Methyl (5-Chloro-1H-benzimidazol-2-yl) 20367-38-8 25mg N
H
N
0025 carbamate) Cl

O
MM0382.09- N O
N
N3-Methylalbendazole 1149360-33-7 25mg N H
S
0025

Albuterol Sulfate, see Salbutamol Sulphate

Alclofenac
Cl O

MM1783.00 Alclofenac 22131-79-9 100mg O


OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-16
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cl O
MM1783.01-
Alclofenac Methyl Ester 23918-07-2 25mg O
O
0025
Cl O

O
MM1783.02 Alclofenac Ethyl Ester 20788-45-8 100mg O

Cl O

O
MM1783.03 Alclofenac Isopropyl Ester 69801-29-2 100mg O

Alendronate Sodium, see Sodium Alendronate

Alfacalcidol

MM3002.00 Alfacalcidol 41294-56-8 50mg H

HO OH

MM3002.01- Impurity A (EP): (1S,3R,5E,7E)-9,10-Secocholesta-5,7,10 H


65445-14-9 25mg
0025 (19)-triene-1,3-diol (trans-Alfacalcidol)
HO OH

Alfentanil Hydrochloride Hydrate


N N
MM0234.00- N

Alfentanil Hydrochloride Monohydrate


N HCl H2O
N
N
70879-28-6 CS 250mg O
O

0250 O

Alfuzosin Hydrochloride
H
MM1004.00- O N N N
O

Alfuzosin Hydrochloride 81403-68-1 250mg O


N
HCl
O

0250 N H2

Impurity A (EP) as Hydrochloride: N-[3-[(4-Amino-6,7- H


MM1004.01- O N N N
O
HCl
N O
dimethoxyquinazolin-2-yl)methylamino]propyl]furan-2- 98902-29-5 25mg O
N H2
0025
carboxamide Hydrochloride
O N Cl

Impurity B (EP): 2-Chloro-6,7-dimethoxyquinazolin- N


MM0085.04 23680-84-4 100mg O
4-amine NH2

O N Cl
MM0085.04- Impurity B (EP): 2-Chloro-6,7-dimethoxyquinazolin- N
23680-84-4 25mg O
0025 4-amine NH2

MM1004.04- Impurity D (EP) as Dihydrochloride: N-(4-Amino-6,7- O N N N H2

dimethoxyquinazolin-2-yl)-N-methylpropane-1,3- n/a 25mg O


N
HCl
0025 diamine Dihydrochloride NH2 2

Algestone Acetophenide
O

MM0476.00 Algestone Acetophenide 24356-94-3 250mg H


H

H
O

H
MM0476.03 16-Dehydroprogesterone 1096-38-4 100mg
H H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-17
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0476.03- H
16-Dehydroprogesterone 1096-38-4 25mg
0025 H H
O

Alimemazine Tartrate, see Trimeprazine Tartrate

Allantoin
O O
H2 N
NH
MM1627.00 Allantoin 97-59-6 250mg N
H N O
H

Allobarbital
H
O N O

MM0899.00 Allobarbital 52-43-7 CS 100mg NH

Allopurinol
O

MM0034.00- NH
Allopurinol 315-30-0 250mg N
0250
N N
H

Impurity A (EP) as Hemisulphate: 5-Amino- O


MM0034.01- 1H-pyrazole-4-carboxamide Hemisulphate N H2
HO
O
S OH
N
Related compound A (USP): 3-Amino-4-
27511-79-1 25mg N
0025 NH2 O
H 2

carboxamidopyrazole
O
Impurity C (EP): 5-(4H-1,2,4-Triazol-4-yl)-
NH2
MM0034.04- 1H-pyrazole-4-carboxamide N
Related compound C (USP): 5-(4H-1,2,4-triazol-4-yl)-1H-
1346604-13-4 25mg
0025 N N
H
pyrazole-4-carboxamide N
N

Impurity D (EP): Ethyl 5-Amino-1H-pyrazole- O

MM0034.05- 4-carboxylate O
N
Related compound D (USP): ethyl 5-amino-1H-pyrazole-4-
6994-25-8 25mg
0025 N NH2
carboxylate H

O
Impurity E (EP): Ethyl 5-(Formylamino)-1H-
MM0034.06- pyrazole-4-carboxylate O
N
Related compound E (USP): ethyl 5-(formylamino)-1H-
31055-19-3 25mg
0025 N N O
pyrazole-4-carboxylate H H

NH
MM0034.07 Oxypurinol 2465-59-0 100mg N
N N O
H H

MM0034.07- NH
Oxypurinol 2465-59-0 25mg N
0025 N N O
H H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-18
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Ethyl (E/Z)-3-(2-Carbethoxy-2-cyanoethenyl)amino-1H- O

O
MM0034.10- pyrazole-4-carboxylate N N
321571-07-7 25mg N N
0025 Related compound F (USP): ethyl-(E/Z)-3-(2-carbethoxy-2- H H
O O
cyanoethenyl)amino-1H-pyrazole-4-carboxylate
O
5-(Formylamino)-1H-pyrazole-4-carboxamide
MM0034.03- NH2
Related compound B (USP): 5-(formylamino)-1H-pyrazole-4- 22407-20-1 25mg N
0025 N
carboxamide N O
H H

Almotriptan Malate
O
N
MM3978.07- S O
4-(Pyrrolidin-1-ylsulfonylmethyl)aniline 334981-10-1 25mg
0025
N H2

MM3978.09- 4-Chloro-1,1-dimethoxybutane (4-Chlorobutyraldehyde O


29882-07-3 100mg Cl
0100 Dimethyl Acetal) O

MM3978.10- 4-Chloro-1,1-diethoxybutane (4-Chlorobutyraldehyde Diethyl O


6139-83-9 100mg Cl
0100 Acetal) O

Alogliptin
H2 N
N
N
MM3928.00-
Alogliptin 850649-61-5 250mg N
0250
O N O

Alosetron Hydrochloride
H
N N

MM3508.00 Alosetron Hydrochloride 122852-69-1 250mg N


N
HCl

MM3508.01 4-Methylimidazole 822-36-6 100mg


N
H

N
MM3508.01-
4-Methylimidazole 822-36-6 25mg
0025 N
H

Alprazolam
N
N
N

MM0136.00 Alprazolam 28981-97-7 CS 100mg Cl N

MM0136.05- Impurity A (EP): (4RS)-3-Amino-6-chloro-2-methyl-4-phenyl- Cl


N
N H2
27537-87-7 25mg
0025 3,4-dihydroquinazolin-4-ol OH

N H2

O
MM0028.03- Impurity E (EP): (2-Amino-5-chlorophenyl)- Cl
719-59-5 25mg
0025 phenylmethanone

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-19
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N N

Impurity G (EP): 7-Chloro-1-methyl-5-phenyl-[1,2,4]triazolo


MM0136.06 448950-89-8 50mg Cl N H2
[4,3-a]quinolin-4-amine

N
HO
N
N

MM0136.02 -Hydroxyalprazolam 37115-43-8 25mg Cl N

2-(2-Acetylhydrazino)-7-chloro-5-phenyl-3H-1,4- H
N N
N H
MM0136.07- benzodiazepine
28910-89-6 25mg Cl N
0025 Related compound A (USP): 2-(2-acetylhydrazino)-7-chloro-
5-phenyl-3H-1,4-benzodiazepine

Alprostadil
O
O
OH

MM1553.00 Alprostadil 745-65-3 50mg


HO
HO

MM1219.10-
Impurity K (EP): Triphenylphosphine Oxide 791-28-6 25mg P O
0025

Alverine Citrate
O
OH
OH

MM0454.00 Alverine Citrate 5560-59-8 250mg N


OH
OH
O

MM0454.02 Impurity A (EP): 1-Chloro-3-phenylpropane 104-52-9 100mg Cl

MM0454.03 Impurity B (EP): 3-Phenylpropan-1-ol 122-97-4 100mg OH

Impurity C (EP) as Hydrochloride: N-Ethyl- HCl


MM0454.04 13125-63-8 100mg NH
3-phenylpropan-1-amine Hydrochloride

MM0454.04- Impurity C (EP) as Hydrochloride: N-Ethyl- HCl


13125-63-8 25mg NH
0025 3-phenylpropan-1-amine Hydrochloride

Impurity D (EP) as Hydrochloride: N-(3- HCl

MM0454.05 Cyclohexylpropyl)-N-ethyl-3-phenyl- n/a 100mg N

propan-1-amine Hydrochloride

MM0454.05- Impurity D (EP) as Hydrochloride: N-(3- HCl

Cyclohexylpropyl)-N-ethyl-3-phenyl- n/a 25mg N


0025 propan-1-amine Hydrochloride
Impurity E (EP) as Hydrochloride: 3-Phenyl-
MM0454.06 N,N-bis(3-phenylpropyl)propan-1-amine 878784-75-9 100mg HCl

Hydrochloride

MM0454.06- Impurity E (EP) as Hydrochloride: 3-Phenyl-


N,N-bis(3-phenylpropyl)propan-1-amine 878784-75-9 25mg HCl

N
0025 Hydrochloride

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-20
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Alvimopan Dihydrate
O
HO OH
N N

MM3703.00 Alvimopan Dihydrate 170098-38-1 100mg H


O
H2O
2

Amantadine Hydrochloride
NH 2
HCl
MM0564.00 Amantadine Hydrochloride 665-66-7 500mg

MM0564.03-
Adamantane 281-23-2 25mg
0025

Ambrisentan
O OH
N
MM3756.00-
Ambrisentan 177036-94-1 250mg O N
0250 O

O OH

OH
MM3756.01 (S)-2-Hydroxy-3-methoxy-3,3-diphenylpropionic Acid 178306-52-0 100mg O

O OH

MM3756.01- OH
(S)-2-Hydroxy-3-methoxy-3,3-diphenylpropionic Acid 178306-52-0 25mg O
0025

Ambroxol Hydrochloride
OH

MM0005.00- Br

Ambroxol Hydrochloride 23828-92-4 250mg N


H HCl

0250 N H2
Br

Br
OH
Impurity A (EP): (2-Amino-3,5-
MM0005.01 50739-76-9 100mg
dibromophenyl)methanol NH2
Br

Br
OH
MM0005.01- Impurity A (EP): (2-Amino-3,5-
50739-76-9 25mg
0025 dibromophenyl)methanol NH2
Br

OH
Impurity B (EP) as Hydrochloride: trans-4-(6,8- Br
N
MM0005.04 Dibromo-1,4-dihydroquinazolin-3(2H)-yl)- 15942-08-2 100mg
N HCl
cyclohexanol Hydrochloride Br
H

OH

MM0005.04- Impurity B (EP) as Hydrochloride: trans-4-(6,8- Br


N
Dibromo-1,4-dihydroquinazolin-3(2H)-yl)- 15942-08-2 25mg
N HCl
0025 cyclohexanol Hydrochloride Br
H

OH

Impurity C (EP): trans-4-[[(E)-2-Amino-3,5- Br


N
MM0005.03 50910-53-7 100mg
dibromobenzyliden]amino]cyclohexanol N H2
Br

OH

MM0005.03- Impurity C (EP): trans-4-[[(E)-2-Amino-3,5- Br


N
50910-53-7 25mg
0025 dibromobenzyliden]amino]cyclohexanol N H2
Br

OH
Impurity D (EP) as Hydrochloride: cis-4-[(2- Br
N
MM0005.05 Amino-3,5-dibromobenzyl)amino]- 1384955-66-1 100mg H HCl
N H2
cyclohexanol Hydrochloride Br

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-21
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH

MM0005.05- Impurity D (EP) as Hydrochloride: cis-4-[(2- Br


N
Amino-3,5-dibromobenzyl)amino]- 1384955-66-1 25mg H HCl
N H2
0025 cyclohexanol Hydrochloride Br

Br
O
Impurity E (EP): 2-Amino-3,5-
MM0005.02 50910-55-9 100mg
dibromobenzaldehyde NH2
Br

Br
O
MM0005.02- Impurity E (EP): 2-Amino-3,5-
50910-55-9 25mg
0025 dibromobenzaldehyde NH2
Br

OH

MM0005.06 trans-4-Aminocyclohexanol Hydrochloride 50910-54-8 100mg H2 N


HCl

OH

MM0005.07 cis-4-Aminocyclohexanol Hydrochloride 56239-26-0 100mg H2 N


HCl

OH
MM0005.07-
cis-4-Aminocyclohexanol Hydrochloride 56239-26-0 25mg H2 N
HCl

0025
O
Br
OH
MM0005.08 2-Amino-3,5-dibromobenzoic Acid 609-85-8 100mg
NH2
Br

O
Br
MM0005.08- OH
2-Amino-3,5-dibromobenzoic Acid 609-85-8 25mg
0025 NH2
Br

OH
O

MM0005.10 trans-2-Amino-N-(4-hydroxycyclohexyl)benzamide 15942-11-7 100mg N


H
NH2

OH
O
MM0005.10-
trans-2-Amino-N-(4-hydroxycyclohexyl)benzamide 15942-11-7 25mg N
H
0025 NH2

OH

trans-4-(6,8-Dibromoquinazolin-3(4H)-yl)cyclohexanol Br
N HCl
MM0005.11 2356152-56-0 100mg N
Hydrochloride Br

OH

MM0005.11- trans-4-(6,8-Dibromoquinazolin-3(4H)-yl)cyclohexanol Br
N HCl
2356152-56-0 25mg N
0025 Hydrochloride Br

Ambutonium Bromide
O
N H2
MM1780.00 Ambutonium Bromide 115-51-5 100mg N
+
Br

Amcinonide
O

O
O

MM3742.00 Amcinonide 51022-69-6 250mg HO


H
O
O

F H
O

Amfenac Sodium Monohydrate


O NH2

MM3533.00 Amfenac Sodium Monohydrate 61618-27-7 250mg O


O
Na
+
H2 O

O N H2
MM3533.01- O
Amfenac Methyl Ester 61941-58-0 25mg O
0025

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-22
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O N H2
O
MM3533.02 Amfenac Ethyl Ester 61941-57-9 100mg O

O N H2
MM3533.02- O
Amfenac Ethyl Ester 61941-57-9 25mg O
0025
O N H2
MM3533.03- O
Amfenac Isopropyl Ester n/a 25mg O
0025
O
H
O N
MM3533.08-
7-Benzoylindolin-2-one (Amfenac Lactam) 51135-38-7 25mg
0025

Amfetamine Sulfate (Amphetamine Sulfate)


NH2
MM0741.00- O O
S
Amfetamine Sulfate 60-13-9 CS 250mg HO OH
0250 2

NH2
HCl
MM0741.06 Amfetamine Hydrochloride 2706-50-5 CS 100mg

OH
Impurity A (EP): (2RS)-1-Phenylpropan-2-ol (1-Phenyl-2-
MM0741.03 698-87-3 100mg
propanol)
O
MM0741.04 Impurity B (EP): 1-Phenylpropan-2-one (Phenylacetone) 103-79-7 100mg

Impurity C (EP) as Hydrochloride: (2S)-2-Amino-1- O


MM1360.02- NH2 HCl
phenylpropan-1-one Hydrochloride (Cathinone 72739-14-1 CS 25mg
0025
Hydrochloride)

MM0528.05- O
Impurity D (EP): Benzaldehyde 100-52-7 500mg
0500

Amifampridin
NH2

MM3483.00 Amifampridin 54-96-6 100mg N


NH2

Amikacin
O
NH2
MM1279.01 Impurity I (EP): (2S)-4-Amino-2-hydroxybutanoic Acid 40371-51-5 100mg HO
OH

O
MM1279.01- NH2
Impurity I (EP): (2S)-4-Amino-2-hydroxybutanoic Acid 40371-51-5 25mg HO
0025 OH

Amikacin Sulfate
HO

HO
O O
N H2
H 2N O HN
MM1279.00- O

Amikacin Sulfate 39831-55-5 250mg


OH

O
HO

O NH2
OH
HO S
O
OH

H 2N
0250 HO OH
OH

O
NH2
MM1279.01 Impurity I (EP): (2S)-4-Amino-2-hydroxybutanoic Acid 40371-51-5 100mg HO
OH

O
MM1279.01- NH2
Impurity I (EP): (2S)-4-Amino-2-hydroxybutanoic Acid 40371-51-5 25mg HO
0025 OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-23
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Amiloride Hydrochloride Dihydrate


O NH
MM0560.00- Cl N
N NH2 HCl H2O
Amiloride Hydrochloride Dihydrate 17440-83-4 250mg H 2
H 2N N NH2
0250
Impurity A (EP): Methyl 3,5-Diamino-6- O

chloropyrazine-2-carboxylate Cl N
O
Related compound A (USP): Methyl 3,5-diamino-6-
MM0560.01 1458-01-1 100mg
H2 N N N H2
chloropyrazine-2-carboxylate
Impurity A (EP): Methyl 3,5-Diamino-6- O
MM0560.01- chloropyrazine-2-carboxylate Cl N
O
Related compound A (USP): Methyl 3,5-diamino-6-
1458-01-1 25mg
0025 H2 N N N H2
chloropyrazine-2-carboxylate
O

Impurity B (EP): 3,5-Diamino-6-chloropyrazine-2-carboxylic Cl N


OH
MM0560.02 4878-36-8 100mg
Acid
H 2N N NH2

O
MM0560.02- Impurity B (EP): 3,5-Diamino-6-chloropyrazine-2-carboxylic Cl N
OH
4878-36-8 25mg
0025 Acid
H 2N N NH2

O
MM0560.05- N
Methyl 3-Aminopyrazine-2-carboxylate 16298-03-6 25mg O
0025
N NH2

MM0560.06- N
3-Aminopyrazine-2-carboxylic Acid 5424-01-1 25mg OH
0025
N NH2

O
MM0560.08- Cl N
Methyl 3-Amino-5,6-dichloropyrazine-2-carboxylate 1458-18-0 25mg O
0025
Cl N N H2

Aminoacridine Hydrochloride Monohydrate


NH2
Aminoacridine Hydrochloride Monohydrate (9- HCl
MM1588.00 52417-22-8 250mg
Aminoacridine Hydrochloride Monohydrate) N
H2O

4-Aminobenzoic Acid (Aminobenzoic Acid)


O

MM0094.03 4-Aminobenzoic Acid 150-13-0 100mg OH

H 2N

MM1255.01- OH
Impurity A (EP): 4-Nitrobenzoic Acid 62-23-7 25mg O +
0025 N
O

O
MM0094.00- O
Impurity B (EP): Ethyl 4-Aminobenzoate (Benzocaine) 94-09-7 250mg
0250 H2 N

H2 N
HCl
MM0093.17 Impurity C (EP) as Hydrochloride: Aniline Hydrochloride 142-04-1 100mg

MM1255.06-
4-Nitrobenzaldehyde 555-16-8 25mg O
0025 +
N
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-24
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
MM1255.07- O
Methyl 4-Aminobenzoate 619-45-4 25mg
0025 H2 N

O
MM1255.08 Isopropyl 4-Aminobenzoate 18144-43-9 100mg
H2 N

O
MM1255.08- O
Isopropyl 4-Aminobenzoate 18144-43-9 25mg
0025 H2 N

Aminocaproic Acid
O
MM0896.00 Aminocaproic Acid 60-32-2 500mg H2 N
OH

Aminoglutethimide
H
O N O

MM1777.00 Aminoglutethimide 125-84-8 250mg NH 2

Aminophenazone
O
N N
N
MM1049.01 Dioxypyramidon 519-65-3 100mg O O

O
N N
MM1049.01- N
Dioxypyramidon 519-65-3 25mg O O
0025

Aminophylline, see Theophylline-Ethylenediamine

Aminosalicylate Sodium, see Sodium Aminosalicylate Dihydrate

Aminotadalafil
O
H
N H2
N
N
N
MM1271.00 Aminotadalafil 385769-84-6 100mg H
O

O
O

Amiodarone Hydrochloride
O
I

MM0697.00 Amiodarone Hydrochloride 19774-82-4 250mg O

O
N
HCl

HO O

Impurity A (EP) as Oxalate: (2-Butylbenzo- O


HO O

MM0697.11 furan-3-yl)[4-[2-(diethylamino)ethoxy]- n/a 100mg O

O
N

phenyl]methanone Oxalate

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-25
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HO O

MM0697.11- Impurity A (EP) as Oxalate: (2-Butylbenzo- O


HO O

furan-3-yl)[4-[2-(diethylamino)ethoxy]- n/a 25mg O

O
N
0025 phenyl]methanone Oxalate
Impurity B (EP) as Hydrochloride: (2-Butylbenzo-
furan-3-yl)[4-[2-(ethylamino)ethoxy]-3,5-di- O
I

MM0697.03 iodophenyl]methanone Hydrochloride 96027-74-6 100mg O

I
O
H
N
HCl

(Desethylamiodarone Hydrochloride)
Related compound B (USP)
Impurity B (EP) as Hydrochloride: (2-Butylbenzo-
MM0697.03- furan-3-yl)[4-[2-(ethylamino)ethoxy]-3,5-di- O
I

iodophenyl]methanone Hydrochloride 96027-74-6 25mg O

I
O
H
N
HCl

0025 (Desethylamiodarone Hydrochloride)


Related compound B (USP)
Impurity C (EP) as Hydrochloride: (2-Butylbenzo- O HCl

furan-3-yl)[4-[2-(diethylamino)ethoxy]-3-iodo- O
I

phenyl]methanone Hydrochloride
MM0697.04 n/a 100mg O

Related compound C (USP)


Impurity C (EP) as Hydrochloride: (2-Butylbenzo- O HCl

MM0697.04- furan-3-yl)[4-[2-(diethylamino)ethoxy]-3-iodo- O
I

phenyl]methanone Hydrochloride
n/a 25mg O
0025
Related compound C (USP)
Impurity D (EP): (2-Butylbenzofuran-3-yl)(4- O
I
hydroxy-3,5-diiodophenyl)methanone O
MM0697.05
Related compound D (USP): (2-butylbenzofuran-3-yl)(4-
1951-26-4 100mg OH
I
hydroxy-3,5-diiodophenyl)methanone
Impurity D (EP): (2-Butylbenzofuran-3-yl)(4- O
I
MM0697.05- hydroxy-3,5-diiodophenyl)methanone O

Related compound D (USP): (2-butylbenzofuran-3-yl)(4-


1951-26-4 25mg OH
0025 I
hydroxy-3,5-diiodophenyl)methanone
Impurity E (EP): (2-Butylbenzofuran-3-yl)(4- O

hydroxyphenyl)methanone O

Related compound E (USP): (2-butylbenzofuran-3-yl)(4-


MM0697.06 52490-15-0 100mg OH

hydroxyphenyl)methanone
Impurity E (EP): (2-Butylbenzofuran-3-yl)(4- O

MM0697.06- hydroxyphenyl)methanone O

Related compound E (USP): (2-butylbenzofuran-3-yl)(4-


52490-15-0 25mg OH
0025
hydroxyphenyl)methanone
O
Impurity F (EP): (2-Butylbenzofuran-3-yl)(4- I
O
MM0697.07 hydroxy-3-iodophenyl)methanone 147030-50-0 100mg OH

Related compound F (USP)


O
Impurity F (EP): (2-Butylbenzofuran-3-yl)(4- I
MM0697.07- O
hydroxy-3-iodophenyl)methanone 147030-50-0 25mg OH
0025 Related compound F (USP)
Impurity H (EP) as Hydrochloride: 2-Chloro-N,N-
diethylethanamine Hydrochloride (2-Chloro-
triethylamine Hydrochloride; (2-Chloroethyl)- HCl
MM0697.09 N
diethylamine Hydrochloride)
869-24-9 100mg
Cl

Related compound H (USP): 2-chloro-N,N-


diethylethanamine
Impurity H (EP) as Hydrochloride: 2-Chloro-N,N-
diethylethanamine Hydrochloride (2-Chloro-
MM0697.09- triethylamine Hydrochloride; (2-Chloroethyl)- HCl
N
diethylamine Hydrochloride)
869-24-9 25mg
0025 Cl

Related compound H (USP): 2-chloro-N,N-


diethylethanamine
O HCl
I

MM0697.10 Amiodarone N-Oxide Hydrochloride n/a 100mg O

O
N
+O

MM0697.15- O
(2-Butylbenzofuran-3-yl)(4-methoxyphenyl)methanone 83790-87-8 100mg O
0100

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-26
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Amiquinsin Hydrochloride Monohydrate


NH2
O HCl
MM3280.00 Amiquinsin Hydrochloride Monohydrate 7125-70-4 50mg H2O
O N

Amisulpride
O O O
S
N
MM0793.00 Amisulpride 71675-85-9 250mg H 2N O
H
N

Impurity A (EP): [(2RS)-1-Ethylpyrrolidin- N


MM0051.01 26116-12-1 100mg H 2N
2-yl]methanamine

Impurity B (EP): 4-Amino-N-[[(2RS)-1-ethyl- O O


S
O

N
MM0793.02 pyrrolidin-2-yl]methyl]-5-(ethylsulphonyl)- 148516-54-5 50mg H 2N OH
H
N

2-hydroxybenzamide
O

MM0793.03- Impurity C (EP): 4-Amino-N-[[(2RS)-1-ethyl- I


N
pyrrolidin-2-yl]methyl]-5-iodo-2-methoxy- 176849-91-5 25mg H 2N O
H
N
0025 benzamide
O
Impurity D (EP): 4-Amino-N-[[(2RS)-1-ethyl- O O
S
N
MM0793.04 pyrrolidin-2-yl]methyl]-2-methoxy-5- 71676-00-1 50mg H 2N O
H
N

(methylsulphonyl)benzamide
O O O

Impurity E (EP): 4-Amino-5-(ethylsulphonyl)- S


OH
MM0793.05 71675-87-1 100mg
2-methoxybenzoic Acid H 2N O

O O O
MM0793.05- Impurity E (EP): 4-Amino-5-(ethylsulphonyl)- S
OH
71675-87-1 25mg
0025 2-methoxybenzoic Acid H 2N O

Amitraz
NH2
Impurity A (BP): 2,4-Dimethylaniline
MM1018.01 95-68-1 100mg
(2,4-Xylidine)

Impurity B (BP): Form-2',4'-xylidide H


N O
MM1018.02 Related compound A (USP): N-(2,4-Dimethylphenyl) 60397-77-5 100mg
formamide
Impurity B (BP): Form-2',4'-xylidide H
N O
MM1018.02-
Related compound A (USP): N-(2,4-Dimethylphenyl) 60397-77-5 25mg
formamide
0025

Amitriptyline Hydrochloride
HCl

MM0062.00- N
Amitriptyline Hydrochloride 549-18-8 250mg
0250

O
Impurity A (EP): 10,11-Dihydro-5H-dibenzo-
MM0062.01 [a,d][7]annulen-5-one (Dibenzosuberone) 1210-35-1 100mg
Related compound A (USP): dibenzosuberone

Impurity B (EP) as Hydrochloride: 3-(5H- HCl

MM0062.02- Dibenzo[a,d][7]annulen-5-ylidene)-N,N- N
6202-23-9 250mg
0250 dimethylpropan-1-amine Hydrochloride
(Cyclobenzaprine Hydrochloride)

Impurity C (EP) as Hydrochloride: 3-(10,11- HCl

Dihydro-5H-dibenzo[a,d][7]annulen-5- N
H
MM0079.00 894-71-3 500mg
ylidene)-N-methylpropan-1-amine
Hydrochloride (Nortriptyline Hydrochloride)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-27
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity D (EP): 5-[3-(Dimethylamino)propyl]-


10,11-dihydro-5H-dibenzo[a,d][7]annulen- OH
N

MM0062.03 5-ol 1159-03-1 100mg


Related compound B (USP): 5-[3-(dimethylamino)propyl]-
10,11-dihydro-5H-dibenzo[a,d]-cyclohepten-5-ol
Impurity D (EP): 5-[3-(Dimethylamino)propyl]-
MM0062.03- 10,11-dihydro-5H-dibenzo[a,d][7]annulen- OH
N

5-ol 1159-03-1 25mg


0025 Related compound B (USP): 5-[3-(dimethylamino)propyl]-
10,11-dihydro-5H-dibenzo[a,d]-cyclohepten-5-ol

Impurity F (EP): (5EZ,10RS)-5-[3-(Dimethyl- N

MM0062.05 amino)propylidene]-10,11-dihydro-5H- 1159-82-6 100mg


dibenzo[a,d][7]annulen-10-ol HO

MM0062.05- Impurity F (EP): (5EZ,10RS)-5-[3-(Dimethyl- N

amino)propylidene]-10,11-dihydro-5H- 1159-82-6 25mg


0025 dibenzo[a,d][7]annulen-10-ol HO

HO
Impurity G (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-
MM0062.14 1210-34-0 100mg
ol (Dibenzosuberol)

HO
MM0062.14- Impurity G (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-
1210-34-0 25mg
0025 ol (Dibenzosuberol)

+
N HCl
MM0062.12 Amitriptyline N-Oxide Hydrochloride 4290-60-2 10mg O

10,11-Dihydro-5H-dibenzo[a,d]cycloheptene
(Dibenzosuberane)
MM0062.13 833-48-7 100mg

MM0062.13- 10,11-Dihydro-5H-dibenzo[a,d]cycloheptene
(Dibenzosuberane)
833-48-7 25mg
0025

O
(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)acetic
MM0062.15 3707-33-3 100mg OH
Acid

O
MM0062.15- (10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)acetic
3707-33-3 25mg OH
0025 Acid

Amlodipine Besilate
H
N NH2
O
O O O
MM0383.00- OH
Amlodipine Besilate 111470-99-6 250mg O O
Cl
O S

0250
H
N NH2
O
O O

MM0383.06 Amlodipine 88150-42-9 100mg O O


Cl

Impurity A (EP): 3-Ethyl 5-Methyl (4RS)-4-


(2-Chlorophenyl)-2-[[2-(1,3-dioxo-1,3-
dihydro-2H-isoindol-2-yl)ethoxy]methyl]- H
O

N N
6-methyl-1,4-dihydropyridine-3,5- O
O
O O
MM0383.01 88150-62-3 100mg
dicarboxylate O O
Cl

Related compound D (USP): 3-Ethyl 5-methyl 4-(2-


chlorophenyl)-2-[2-(1,3-dioxoisoindolin-2-yl)ethoxy]methyl-6-
methyl-1,4-dihydropyridine-3,5-dicarboxylate

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-28
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP): 3-Ethyl 5-Methyl (4RS)-4-


(2-Chlorophenyl)-2-[[2-(1,3-dioxo-1,3-
dihydro-2H-isoindol-2-yl)ethoxy]methyl]- H
O

N N
MM0383.01- 6-methyl-1,4-dihydropyridine-3,5- O
O
O O

dicarboxylate
88150-62-3 25mg O O
0025 Cl

Related compound D (USP): 3-Ethyl 5-methyl 4-(2-


chlorophenyl)-2-[2-(1,3-dioxoisoindolin-2-yl)ethoxy]methyl-6-
methyl-1,4-dihydropyridine-3,5-dicarboxylate
Impurity B (EP): 3-Ethyl 5-Methyl (4RS)-4-
(2-Chlorophenyl)-6-methyl-2-[[2-[[2-
(methylcarbamoyl)benzoyl]amino]- H
N
H
N O
O O

ethoxy]methyl]-1,4-dihydropyridine- O O
N
H
O O

3,5-dicarboxylate
MM0383.02 721958-72-1 100mg Cl

Related compound B (USP): 3-Ethyl 5-methyl 4-(2-


chlorophenyl)-6-methyl-2-(2-[2-(methylcarbamoyl)benzamido]
ethoxymethyl)-1,4-dihydropyridine-3,5-dicarboxylate
Impurity B (EP): 3-Ethyl 5-Methyl (4RS)-4-
(2-Chlorophenyl)-6-methyl-2-[[2-[[2-
(methylcarbamoyl)benzoyl]amino]- H
N
H
N O
O O
MM0383.02- ethoxy]methyl]-1,4-dihydropyridine- O O
N
H
O O

3,5-dicarboxylate
721958-72-1 25mg Cl
0025
Related compound B (USP): 3-Ethyl 5-methyl 4-(2-
chlorophenyl)-6-methyl-2-(2-[2-(methylcarbamoyl)benzamido]
ethoxymethyl)-1,4-dihydropyridine-3,5-dicarboxylate
H

Ethyl Methyl (4RS)-2,6-Bis[(2-aminoethoxy)- H 2N


O
O
N
O
O
NH2

MM0383.03 methyl]-4-(2-chlorophenyl)-1,4-dihydropyridine- n/a 100mg O O


Cl HCl

3,5-dicarboxylate Dihydrochloride 2

MM0383.03- Ethyl Methyl (4RS)-2,6-Bis[(2-aminoethoxy)- H 2N


O
O
N
O
O
NH2

methyl]-4-(2-chlorophenyl)-1,4-dihydropyridine- n/a 25mg O O


Cl HCl
0025 3,5-dicarboxylate Dihydrochloride 2

Impurity D (EP): 3-Ethyl 5-Methyl 2-[(2- N


O
NH2

Aminoethoxy)methyl]-4-(2-chlorophenyl)- O O

MM0383.04 O O
6-methylpyridine-3,5-dicarboxylate
113994-41-5 100mg Cl

Related compound A (USP)


Impurity D (EP) as Fumarate: 3-Ethyl 5-Methyl 2-[(2- N
O
NH2

Aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine- O

O O
O

O
MM0383.12 2138811-33-1 100mg
3,5-dicarboxylate Fumarate Cl
HO

O
OH

Related compound A (USP)


Impurity D (EP) as Fumarate: 3-Ethyl 5-Methyl 2-[(2- N
O
NH2

MM0383.12- Aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine- O

O O
O

O
2138811-33-1 25mg
0025 3,5-dicarboxylate Fumarate Cl
HO

O
OH

Related compound A (USP)


Impurity E (EP): Diethyl (4RS)-2-[(2-Amino-
ethoxy)methyl]-4-(2-chlorophenyl)-6- H
N
O
NH2

methyl-1,4-dihydropyridine-3,5-dicarboxylate O O

MM0383.10
Related compound E (USP): Diethyl 2-[(2-aminoethoxy) O O
140171-65-9 100mg Cl

methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-
dicarboxylate
Impurity E (EP): Diethyl (4RS)-2-[(2-Amino-
ethoxy)methyl]-4-(2-chlorophenyl)-6- H
N
O
NH2

MM0383.10- methyl-1,4-dihydropyridine-3,5-dicarboxylate O O

Related compound E (USP): Diethyl 2-[(2-aminoethoxy) O O


140171-65-9 25mg Cl
0025
methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-
dicarboxylate
Impurity F (EP): Dimethyl (4RS)-2-[(2-Amino-
ethoxy)methyl]-4-(2-chlorophenyl)-6- H
N
O
N H2

methyl-1,4-dihydropyridine-3,5-dicarboxylate O O

Related compound F (USP): Dimethyl 2-[(2-aminoethoxy)


MM0383.09 140171-66-0 100mg O O
Cl

methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-
dicarboxylate
Impurity F (EP): Dimethyl (4RS)-2-[(2-Amino-
ethoxy)methyl]-4-(2-chlorophenyl)-6- H
N
O
N H2

MM0383.09- methyl-1,4-dihydropyridine-3,5-dicarboxylate O O

Related compound F (USP): Dimethyl 2-[(2-aminoethoxy)


140171-66-0 25mg O O
0025 Cl

methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-
dicarboxylate

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-29
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity G (EP): Dimethyl 4-(2-Chlorophenyl)- H


N

2,6-dimethyl-1,4-dihydropyridine-3,5-di- O O

MM0383.07 carboxylate 43067-01-2 100mg O O


Related compound C (USP): Dimethyl 4-(2-chlorophenyl)- Cl

2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
Impurity G (EP): Dimethyl 4-(2-Chlorophenyl)- H
N

MM0383.07- 2,6-dimethyl-1,4-dihydropyridine-3,5-di- O O

carboxylate 43067-01-2 25mg O O


0025 Related compound C (USP): Dimethyl 4-(2-chlorophenyl)- Cl

2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
Impurity H (EP): 2-[[2-[[(4RS)-4-(2-Chlorophenyl)- H
N
H
N

3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6- O
O
O O
O OH
MM0383.11 318465-73-5 100mg
methyl-1,4-dihydropyridin-2-yl]methoxy]ethyl]- O O
Cl

carbamoyl]benzoic Acid
Impurity H (EP): 2-[[2-[[(4RS)-4-(2-Chlorophenyl)- H
N
H
N

MM0383.11- 3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6- O
O
O O
O OH
318465-73-5 25mg
0025 methyl-1,4-dihydropyridin-2-yl]methoxy]ethyl]- O O
Cl

carbamoyl]benzoic Acid
O
OH
O S
MM0383.05 Benzenesulfonic Acid 98-11-3 100mg

O
OH
O S
MM0383.05-
Benzenesulfonic Acid 98-11-3 25mg
0025

MM0383.13- O
Cl
Ethyl 4-Chloroacetoacetate 638-07-3 100mg O O
0100
H 2N

MM0003.08 Methyl 3-Aminobut-2-enoate 14205-39-1 100mg O

H 2N
MM0003.08- O
Methyl 3-Aminobut-2-enoate 14205-39-1 25mg
0025
O

H H
N N H
O3-Ethyl O5-Methyl 4-(2-Chlorophenyl)-2-(2- O

MM0383.14- O O O

formamidoethoxymethyl)-6-methyl-1,4-dihydropyridine-3,5- 93848-81-8 25mg O O


0025 Cl

dicarboxylate (N-Formylamlodipine)
5-Ethyl 7-Methyl 6-(2-Chlorophenyl)-8-methyl-3,4,6,7-
O

tetrahydro-2H-1,4-benzoxazine-5,7-dicarboxylate (5- NH

MM0383.15- O O
Ethyl 7-Methyl 6-(2-Chlorophenyl)-8-methyl-3,4,6,7- 496024-43-2 25mg
O O
0025 Cl
tetrahydro-2H-1,4-benzo[b][1,4]oxazine-5,7-
dicarboxylate)

MM0383.16- O
2-Chlorobenzaldehyde 89-98-5 500mg
0500 Cl

H
N N +
2-[(2-Azidoethoxy)methyl]-4-(2-chlorophenyl)-3- O N
N
MM0383.18- O O

(ethoxycarbonyl)-5-(methoxycarbonyl)-6-methyl-1,4- 88150-46-3 25mg O O


Cl
0025
dihydropyridine

MM0383.20- +N O
N O
N
Ethyl 4-(2-Azidoethoxy)-3-oxobutanoate 88150-45-2 100mg O O
0100

N1,N3-Di[2-[[4-(2-Chlorophenyl)-3-ethoxycarbonyl-5- H
N
H
N
H
N
H
N
MM0383.25- O
O
O O O
O
O O

2309467-38-5 25mg O O O O
methoxycarbonyl-6-methyl-1,4-dihydropyridin-2-yl]methoxy] Cl Cl

0025
ethyl]benzene-1,3-dicarboxamide

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-30
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Amlodipine Maleate
H
N NH2 O
O
O O OH

MM0631.00 Amlodipine Maleate 88150-47-4 100mg O O


Cl
OH

Amlodipine Mesilate
H
N N H2
O
O O
O O

MM0592.00 Amlodipine Mesilate 246852-12-0 100mg O O


Cl
HO
S

Amobarbital
H
O N O

NH
MM1353.00 Amobarbital 57-43-2 CS 100mg
O

Amodiaquine Dihydrochloride Dihydrate


Cl N

MM0617.00 Amodiaquine Dihydrochloride Dihydrate 6398-98-7 500mg HN


N
HCl
2
H2 O
2

OH

N
H
MM0617.01 4-Acetamido-2-diethylaminomethylphenol 121-78-8 100mg N

O
OH

N
MM0617.01- H
4-Acetamido-2-diethylaminomethylphenol 121-78-8 25mg N
0025
O
OH

Cl N

7-Chloro-4-(4-hydroxyphenylamino)-
MM0617.02 HN
quinoline
81099-86-7 100mg
OH

Cl N

MM0617.02- 7-Chloro-4-(4-hydroxyphenylamino)-
HN
quinoline
81099-86-7 25mg
0025
OH

Cl N

MM0617.03 4,7-Dichloroquinoline 86-98-6 100mg


Cl

Cl N
MM0617.03-
4,7-Dichloroquinoline 86-98-6 25mg
0025
Cl
Cl N

HN HCl
MM0617.04 Monodesethylamodiaquine Dihydrochloride 79049-30-2 100mg HN
2

OH

Cl N

MM0617.04- HN HCl
Monodesethylamodiaquine Dihydrochloride 79049-30-2 25mg HN
2

0025 OH

Cl N

+
MM0617.08- N
O
Amodiaquine N-Oxide 102391-07-1 25mg HN
0025
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-31
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Amorolfine Hydrochloride
AND Enantiomer
N
HCl
MM3511.00 Amorolfine Hydrochloride 78613-38-4 250mg O

Amoxapine
NH
N N
MM1773.00-
Amoxapine 14028-44-5 250mg
0250 O
Cl

Amoxicillin Trihydrate
O
OH
H2O O
MM0232.00- 3
N H2 N
H
Amoxicillin Trihydrate 61336-70-7 250mg N
S
0250 H
O
HO

Impurity A (EP): (2S,5R,6R)-6-Amino-3,3-


dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- O
OH
heptane-2-carboxylic Acid O
MM0026.04 (6-Aminopenicillanic Acid) 551-16-6 100mg N

Related compound A (USP): (2S,5R,6R)-6-Amino-3,3- H 2N S


H
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic
acid
Impurity A (EP): (2S,5R,6R)-6-Amino-3,3-
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- O
OH
MM0026.04- heptane-2-carboxylic Acid O
(6-Aminopenicillanic Acid) 551-16-6 25mg N
0025 Related compound A (USP): (2S,5R,6R)-6-Amino-3,3- H 2N S
H
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic
acid
Impurity B (EP): (2S,5R,6R)-6-[[(2S)-2-Amino-
O
2-(4-hydroxyphenyl)acetyl]amino]-3,3- O
OH

N H2 N
MM0232.02 dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- 26889-93-0 100mg H
N
S
H
heptane-2-carboxylic Acid (L-Amoxicillin) HO
O

Related compound B (USP): L-amoxicillin


Impurity B (EP): (2S,5R,6R)-6-[[(2S)-2-Amino-
O

MM0232.02- 2-(4-hydroxyphenyl)acetyl]amino]-3,3- O
OH

N H2 N
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- 26889-93-0 25mg H
N
S
H
0025 heptane-2-carboxylic Acid (L-Amoxicillin) HO
O

Related compound B (USP): L-amoxicillin


Impurity C (EP): (4S)-2-[5-(4-Hydroxyphenyl)-
3,6-dioxopiperazin-2-yl]-5,5-dimethyl- O
OH

thiazolidine-4-carboxylic Acid H
HN

MM0232.03 (Amoxicillin Diketopiperazines) 94659-47-9 100mg O N


S

Related compound C (USP): (4S)-2-[5-(4-hydroxyphenyl)- N


H
O

HO
3,6-dioxopiperazin-2-yl]-5,5-dimethylthiazolidine-4-carboxylic
acid
Impurity C (EP): (4S)-2-[5-(4-Hydroxyphenyl)-
3,6-dioxopiperazin-2-yl]-5,5-dimethyl- O
OH

MM0232.03- thiazolidine-4-carboxylic Acid H


HN

(Amoxicillin Diketopiperazines) 94659-47-9 25mg O N


S

0025 Related compound C (USP): (4S)-2-[5-(4-hydroxyphenyl)- N


H
O

HO
3,6-dioxopiperazin-2-yl]-5,5-dimethylthiazolidine-4-carboxylic
acid
Impurity D (EP) as Sodium Salt: (4S)-2-[[[(2R)-
2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-
carboxymethyl]-5,5-dimethylthiazolidine-4- O
O Na
+

carboxylic Acid Sodium Salt (Penicilloic N H2


H
HN
MM0232.04 68728-47-2 100mg N

Acids of Amoxicillin Sodium Salt) HO


O
HO O
S

Related compound D (USP): (4S)-2-[(R)-2-Amino-2-(4-


hydroxyphenyl)acetamido](carboxy)methyl-5,5-
dimethylthiazolidine-4-carboxylic acid

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-32
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity D (EP) as Sodium Salt: (4S)-2-[[[(2R)-


2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-
carboxymethyl]-5,5-dimethylthiazolidine-4- O
O Na
+

MM0232.04- carboxylic Acid Sodium Salt (Penicilloic N H2


H
HN
N

Acids of Amoxicillin Sodium Salt)


68728-47-2 25mg S
0025 HO
O
HO O

Related compound D (USP): (4S)-2-[(R)-2-Amino-2-(4-


hydroxyphenyl)acetamido](carboxy)methyl-5,5-
dimethylthiazolidine-4-carboxylic acid
Impurity E (EP): (2RS,4S)-2-[[[(2R)-2-Amino-2- O
OH

(4-hydroxyphenyl)acetyl]amino]methyl]-5,5- 178738-48-2 and NH2


H
HN
MM0232.05 50mg N
dimethylthiazolidine-4-carboxylic Acid 178738-49-3 O
S

HO
(Penilloic Acids of Amoxicillin)
Impurity F (EP): 3-(4-Hydroxyphenyl)- HO N

pyrazin-2-ol
MM0232.06 N
Related compound F (USP): 3-(4-Hydroxyphenyl)pyrazin-2-
126247-63-0 100mg
ol; phenylpyrazinediol HO

Impurity F (EP): 3-(4-Hydroxyphenyl)- HO N

MM0232.06- pyrazin-2-ol
N
Related compound F (USP): 3-(4-Hydroxyphenyl)pyrazin-2-
126247-63-0 25mg
0025
ol; phenylpyrazinediol HO

Impurity G (EP): (2S,5R,6R)-6-[[(2R)-2-[[(2R)-2-


Amino-2-(4-hydroxyphenyl)acetyl]amino]-2-
(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-
7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- NH2
O
O
OH

carboxylic Acid (D-(4-Hydroxyphenyl)- HO


N
H
O

H
N

glycylamoxicillin)
MM0232.07 188112-75-6 100mg N
S
H
O
HO
Related compound G (USP): (2S,5R,6R)-6-(R)-2-[(R)-2-
Amino-2-(4-hydroxyphenyl)acetamido]-2-(4-hydroxyphenyl)
acetamido-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]
heptane-2-carboxylic acid
Impurity G (EP): (2S,5R,6R)-6-[[(2R)-2-[[(2R)-2-
Amino-2-(4-hydroxyphenyl)acetyl]amino]-2-
(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-
7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- NH2
O
O
OH
MM0232.07- carboxylic Acid (D-(4-Hydroxyphenyl)- HO
N
H
O

H
N

glycylamoxicillin)
188112-75-6 25mg N
S
0025 H
O
HO
Related compound G (USP): (2S,5R,6R)-6-(R)-2-[(R)-2-
Amino-2-(4-hydroxyphenyl)acetamido]-2-(4-hydroxyphenyl)
acetamido-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]
heptane-2-carboxylic acid
Impurity H (EP): (2R)-2-[(2,2- O

Dimethylpropanoyl)amino]-2- NH
MM0232.08 (4-hydroxyphenyl)acetic Acid 205826-86-4 100mg OH

Related compound H (USP): (R)-2-(4-hydroxyphenyl)-2- O


HO
pivalamidoacetic acid
Impurity H (EP): (2R)-2-[(2,2- O

MM0232.08- Dimethylpropanoyl)amino]-2- NH
(4-hydroxyphenyl)acetic Acid 205826-86-4 25mg OH
0025 Related compound H (USP): (R)-2-(4-hydroxyphenyl)-2- O
HO
pivalamidoacetic acid
Impurity I (EP): (2R)-2-Amino-2-(4- NH2

hydroxyphenyl)acetic Acid OH
MM0232.09
Related compound I (USP): (R)-2-Amino-2-(4-
22818-40-2 100mg
O
HO
hydroxyphenyl)acetic acid
Impurity I (EP): (2R)-2-Amino-2-(4- NH2
MM0232.09- hydroxyphenyl)acetic Acid OH

Related compound I (USP): (R)-2-Amino-2-(4-


22818-40-2 25mg
0025 O
HO
hydroxyphenyl)acetic acid
NH2

(2R)-2-Amino-2-(4-hydroxyphenyl)- NH2

acetamide
MM0232.12 54397-23-8 100mg
O
HO

NH2
MM0232.12- (2R)-2-Amino-2-(4-hydroxyphenyl)- NH2

acetamide
54397-23-8 25mg
0025 O
HO

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-33
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

NH2
MM0232.25- O
Methyl (2S)-Amino(4-hydroxyphenyl)ethanoate Hydrochloride 127369-30-6 25mg HCl
O
0025 HO

Amphetamine Sulfate, see Amfetamine Sulfate

Ampicillin Sodium
O +
O Na
O
N H2 N
MM0253.00 Ampicillin Sodium 69-52-3 500mg H
N S
H
O

O
OH
H2 O O
3 N H2 N
MM0253.15 Ampicillin Trihydrate 7177-48-2 500mg H
N S
H
O

O
Impurity A (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
MM0026.04 551-16-6 100mg
heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H

O
Impurity A (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
MM0026.04- dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
551-16-6 25mg
0025 heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H

Impurity B (EP): (2S,5R,6R)-6-[[(2S)-2-Amino- O


OH
O
2-phenylacetyl]amino]-3,3-dimethyl-7-oxo- N H2
H
N
MM0253.02 19379-33-0 100mg N
4-thia-1-azabicyclo[3.2.0]heptane-2- O
H
S

carboxylic Acid (L-Ampicillin)


Impurity B (EP): (2S,5R,6R)-6-[[(2S)-2-Amino- O
OH
O
MM0253.02- 2-phenylacetyl]amino]-3,3-dimethyl-7-oxo- N H2
H
N
19379-33-0 25mg N
0025 4-thia-1-azabicyclo[3.2.0]heptane-2- O
H
S

carboxylic Acid (L-Ampicillin)


O
OH
Impurity C (EP): (4S)-2-(3,6-Dioxo-5-phenyl-
HN
piperazin-2-yl)-5,5-dimethylthiazolidine-4- O
H
N S
MM0253.03 49841-96-5 100mg
carboxylic Acid (Diketopiperazines of N O
Ampicillin) H

O
OH
Impurity C (EP): (4S)-2-(3,6-Dioxo-5-phenyl-
HN
MM0253.03- piperazin-2-yl)-5,5-dimethylthiazolidine-4- O
H
N S
49841-96-5 25mg
0025 carboxylic Acid (Diketopiperazines of N O
Ampicillin) H

Impurity D (EP) as Sodium Salt: (4S)-2-


O +

[[[(2R)-2-Amino-2-phenylacetyl]amino]- O Na

N H2 HN
MM0253.04 carboxymethyl]-5,5-dimethylthiazolidine- 1642559-70-3 100mg H
N S

4-carboxylic Acid Sodium Salt (Penicilloic O


HO O

Acids of Ampicillin Sodium Salt)


Impurity D (EP) as Sodium Salt: (4S)-2-
O +

MM0253.04- [[[(2R)-2-Amino-2-phenylacetyl]amino]- O Na

N H2 HN
carboxymethyl]-5,5-dimethylthiazolidine- 1642559-70-3 25mg H
N S
0025 4-carboxylic Acid Sodium Salt (Penicilloic O
HO O

Acids of Ampicillin Sodium Salt)


Impurity F (EP): (2RS,4S)-2-[[[(2R)-2-Amino-2- O
OH

phenylacetyl]amino]methyl]-5,5-dimethyl- 124774-48-7 and NH2


H
HN
MM0253.06 100mg N
thiazolidine-4-carboxylic Acid 124774-49-8 S

O
(Penilloic Acids of Ampicillin)
Impurity F (EP): (2RS,4S)-2-[[[(2R)-2-Amino-2- O
OH

MM0253.06- phenylacetyl]amino]methyl]-5,5-dimethyl- 124774-48-7 and NH2


H
HN
25mg N
0025 thiazolidine-4-carboxylic Acid 124774-49-8 S

O
(Penilloic Acids of Ampicillin)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-34
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HO N

MM0253.08 Impurity H (EP): 3-Phenylpyrazin-2-ol 73200-73-4 100mg N

HO N

MM0253.08-
Impurity H (EP): 3-Phenylpyrazin-2-ol 73200-73-4 25mg N
0025

Impurity K (EP): (2R)-2-[(2,2- NH


MM0253.11 Dimethylpropanoyl)amino]-2- 40610-41-1 100mg OH
phenylacetic Acid
O

MM0253.11- Impurity K (EP): (2R)-2-[(2,2- NH


Dimethylpropanoyl)amino]-2- 40610-41-1 25mg OH
0025 phenylacetic Acid
O

NH2
Impurity L (EP): (2R)-2-Amino-2-phenylacetic OH
MM0253.12 875-74-1 100mg
Acid (D-Phenylglycine) O

NH2
MM0253.12- Impurity L (EP): (2R)-2-Amino-2-phenylacetic OH
875-74-1 25mg
0025 Acid (D-Phenylglycine) O

O
OH
O
N H2 N
MM0253.16 Ampicillin, anhydrous 69-53-4 500mg H
N S
H
O

Amprenavir
N H2
OH
H

MM3582.00 Amprenavir 161814-49-9 100mg O


O

O
N N

O O
S

Amprolium Hydrochloride
Cl N H2
HCl
+
MM1772.00 Amprolium Hydrochloride 137-88-2 250mg N N

Amylmetacresol
OH

MM1132.00 Amylmetacresol 1300-94-3 250mg

OH

MM1132.02 Impurity B (EP): 3-Methylphenol (m-Cresol) 108-39-4 250mg

OH
MM1132.04-
Impurity D (EP): 4-Methylphenol (p-Cresol) 106-44-5 100mg
0100

Anagrelide Hydrochloride
H
N N

MM3250.00 Anagrelide Hydrochloride 58579-51-4 250mg Cl


N
O
HCl

Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-35
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Ethyl 2-(6-Amino-2,3-dichlorobenzylamino)acetate
NH2
O
MM3250.01- Hydrochloride H
N HCl
85325-12-8 25mg Cl O
Cl
0025 Related compound A (USP): ethyl 2-(6-amino-2,3-
dichlorobenzylamino)acetate
(2-Amino-5,6-dichloroquinazolin-3(4H)-yl)acetic Acid
N N H2

Hydrochloride N HCl
MM3250.04 n/a 100mg Cl

Related compound B (USP): (2-amino-5,6- Cl


O OH

dichloroquinazolin-3(4H)-yl)acetic acid
(2-Amino-5,6-dichloroquinazolin-3(4H)-yl)acetic Acid
N N H2

MM3250.04- Hydrochloride N HCl


n/a 25mg Cl

0025 Related compound B (USP): (2-amino-5,6- Cl


O OH

dichloroquinazolin-3(4H)-yl)acetic acid
Ethyl 2-(5,6-Dichloro-2-imino-1,2-dihydroquinazolin-3(4H)-yl) N N H2

acetate Hydrobromide N HBr


MM3250.03 70381-75-8 100mg Cl
Related compound C (USP): Ethyl 2-(5,6-dichloro-2-imino- Cl
O O

1,2-dihydroquinazolin-3(4H)-yl)acetate
Ethyl 2-(5,6-Dichloro-2-imino-1,2-dihydroquinazolin-3(4H)-yl) N N H2

MM3250.03- acetate Hydrobromide N HBr


70381-75-8 25mg Cl
0025 Related compound C (USP): Ethyl 2-(5,6-dichloro-2-imino- Cl
O O

1,2-dihydroquinazolin-3(4H)-yl)acetate

Anastrozole
N

N
MM1250.00 Anastrozole 120511-73-1 250mg N
N

MM1250.05- Impurity A (EP): 2-[3-[(1RS)-1-Cyanoethyl]-5-(1H-1,2,4- N


N
1215780-15-6 100mg N
0100 triazol-1-ylmethyl)phenyl]-2-methylpropanenitrile
N

MM1250.02- Impurity C (EP): 2,2'-[5-(Bromomethyl)benzene-1,3-diyl]bis(2- Br


120511-84-4 25mg
0025 methylpropanenitrile)

N
Br

MM1250.07- Impurity D (EP): 2,2 -[5-(Dibromomethyl)benzene-1,3-diyl]bis Br


1027160-12-8 25mg
0025 (2-methylpropanenitrile)

MM1250.04- Impurity E (EP): 2,2'-[5-(Hydroxymethyl)benzene-1,3-diyl]bis HO


120511-88-8 25mg
0025 (2-methylpropanenitrile)
N

O O
Impurity F (EP) as Hydrate: 4-Methylbenzenesulfonic Acid S
OH H2O
MM0598.02 6192-52-5 100mg
Hydrate (4-Methylbenzenesulphonic Acid Hydrate)
N

MM1250.08- Impurity G (EP): 2,2'-[5-(4H-1,2,4-Triazol-4-ylmethyl) N


N
120511-92-4 25mg N
0025 benzene-1,3-diyl]bis(2-methylpropanenitrile) (Isoanastrozole)
N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-36
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity H (EP): 2,2 -(5-Methylbenzene-1,3-diyl)bis(2-


methylpropanenitrile)
MM1250.03 120511-72-0 100mg
Related compound A (USP): 2,2'-(5-methyl-1,3-phenylene)bis(2-
methylpropanenitrile)
N

Impurity H (EP): 2,2 -(5-Methylbenzene-1,3-diyl)bis(2-


MM1250.03- methylpropanenitrile)
120511-72-0 25mg
0025 Related compound A (USP): 2,2'-(5-methyl-1,3-phenylene)bis(2-
methylpropanenitrile)
N

N
MM1250.09- Impurity I (EP): 2,2'-[5-(Chloromethyl)benzene-1,3-diyl]bis(2- Cl
e 120511-91-3 25mg
w
0025 methylpropanenitrile)

N
O

MM1250.01- Anastrozole Carboxylic Acid (3,5-Bis(1-cyano-1-methylethyl) HO


1085181-50-5 25mg
0025 benzoic Acid)
N

N
N
MM0235.09 4-Amino-1,2,4-triazole 584-13-4 100mg N
H 2N

N
MM0235.09- N
4-Amino-1,2,4-triazole 584-13-4 25mg N
0025
H 2N

MM1250.10-
5-Methylbenzene-1,3-diacetonitrile 120511-74-2 25mg
0025

N
MM1250.12- 2-[3-(2-Cyanopropan-2-yl)-5-(1H-1,2,4-triazol-1-ylmethyl) N
120512-03-0 25mg N
0025 phenyl]-2-methylpropanamide N H2

O NH2

N
MM1250.13- 2,2 -[5-(1H-1,2,4-Triazol-1-yl)methylbenzene-1,3-diyl]bis(2- N
N
120512-04-1 25mg
0025 methylpropanamide) NH2

HO O

2,2 -[5-(1H-1,2,4-Triazol-1-yl)methylbenzene-1,3-diyl]bis(2- N
MM1250.15- N
N
methylpropanoic Acid) 1338800-81-9 25mg
0025 OH

Br

MM1250.17-
5-Methyl-1,3-bis(bromomethyl)benzene 19294-04-3 25mg
0025

Br

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-37
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Androstanolone
OH

H
MM0565.00 Androstanolone 521-18-6 250mg H H
O
H

Anecortave Acetate
O
OH
HO O
MM0187.01- H
Hydrocortisone 17-Acetate 16463-74-4 25mg O
0025 H H
O

Anise Oil

MM0164.01 trans-Anethole 4180-23-8 100mg


O

MM0164.02 Estragole 140-67-0 100mg


O

O
MM0164.03 Anisaldehyde 123-11-5 100mg
O

MM0164.05 Linalol 78-70-6 100mg


HO

MM0164.06 cis-Anethole 25679-28-1 100mg


O

Antazoline Hemisulfate

MM0866.00- N O O
N S
Antazoline Hemisulfate 84803-70-3 250mg N
H
HO OH
0250 2

Antazoline Hydrochloride

MM0171.00- HCl

Antazoline Hydrochloride 2508-72-7 250mg N


N

0250 N
H

Impurity A (EP) as Dihydrochloride: N-(2-Aminoethyl)-2-


(benzylphenylamino)-acetamide Dihydrochloride O
MM0171.01 n/a 100mg N
N
NH2 HCl
2
Related compound A (USP): N-(2-Aminoethyl)-2-[benzyl H

(phenyl)amino]acetamide
Impurity A (EP) as Dihydrochloride: N-(2-Aminoethyl)-2-
MM0171.01- (benzylphenylamino)-acetamide Dihydrochloride O
n/a 25mg N
N
NH2 HCl
2
0025 Related compound A (USP): N-(2-Aminoethyl)-2-[benzyl H

(phenyl)amino]acetamide

NH
MM0171.03-
N-Benzylaniline 103-32-2 25mg
0025

N
2-Chloromethyl-4,5-dihydro-1H-imidazole HCl
MM0171.04 N
Hydrochloride
13338-49-3 100mg
H
Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-38
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N
MM0171.04- 2-Chloromethyl-4,5-dihydro-1H-imidazole HCl
N
Hydrochloride
13338-49-3 25mg
0025 H
Cl

Antazoline Phosphate

N OH
MM0561.00 Antazoline Phosphate 154-68-7 500mg N
N
HO

O
P
OH
H

Anthralin, see Dithranol

Antipyrine, see Phenazone

Apixaban
O
NH2

N
N

MM3754.00 Apixaban 503612-47-3 100mg O


O
N

O
O

N
MM3754.01- O
N
N
Apixaban Ethyl Ester 503614-91-3 25mg N
O
0025
O

O
MM3754.03-
-Valerolactam 675-20-7 100mg NH
0100

Apomorphine Hydrochloride Hemihydrate


OH
HCl
HO 2

MM0562.00 Apomorphine Hydrochloride Hemihydrate 41372-20-7 250mg N H2 O


H
2

Impurity B (EP) as Hydrochloride Trihydrate: Morphine H HCl H 2O


MM0037.00 6055-06-7 CS 250mg 3

Hydrochloride Trihydrate HO O OH

O
O
MM0562.05- Apomorphine o-Quinone (6a,7-Didehydroaporphine-10,11-
18605-40-8 25mg
0025 dione) N

O
HO
MM0562.06-
Apomorphine p-Quinone 24192-17-4 25mg
0025 N
O

Apremilast
O O

NH O O
MM3907.00-
Apremilast 608141-41-9 250mg N
0250 S
O
O O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-39
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Aprepitant
O
NH O F F
HN
N
N O F

MM3251.00 Aprepitant 170729-80-3 250mg


F
F
F
F

3-[[(2R,3R)-2-[(R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-
(4-fluorophenyl)morpholino]methyl]-1H-1,2,4-triazol-5(4H)- O
NH O F F
HN
N
one ((R,R,R)-Aprepitant) N O F

MM3251.01 1148113-53-4 100mg


Related compound A (USP): 3-[[(2R,3R)-2-[(R)-1-[3,5-Bis F
F
F
F

(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholino]
methyl]-1H-1,2,4-triazol-5(4H)-one
3-[[(2R,3R)-2-[(R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-
(4-fluorophenyl)morpholino]methyl]-1H-1,2,4-triazol-5(4H)- O
NH O F F
HN
N
MM3251.01- one ((R,R,R)-Aprepitant) N O F

1148113-53-4 25mg
0025 Related compound A (USP): 3-[[(2R,3R)-2-[(R)-1-[3,5-Bis F
F
F
F

(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholino]
methyl]-1H-1,2,4-triazol-5(4H)-one
3-[[(2S,3R)-2-[(S)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-
(4-fluorophenyl)morpholino]methyl]-1H-1,2,4-triazol-5(4H)- O
NH O F F
HN
N
one ((S,R,S)-Aprepitant) N O F

MM3251.02 172822-29-6 100mg


Related compound B (USP): 3-[[(2S,3R)-2-[(S)-1-[3,5-Bis F
F
F
F

(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholino]
methyl]-1H-1,2,4-triazol-5(4H)-one
3-[[(2S,3R)-2-[(S)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-
(4-fluorophenyl)morpholino]methyl]-1H-1,2,4-triazol-5(4H)- O
NH O F F
HN
N
MM3251.02- one ((S,R,S)-Aprepitant) N O F

172822-29-6 25mg
0025 Related compound B (USP): 3-[[(2S,3R)-2-[(S)-1-[3,5-Bis F
F
F
F

(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholino]
methyl]-1H-1,2,4-triazol-5(4H)-one

Aprobarbital
H
O N O

MM1706.00 Aprobarbital 77-02-1 100mg NH

Apronalide
O O

H 2N N
MM1673.00 Apronalide 528-92-7 250mg H

Argatroban Monohydrate
O OH
NH O

H2 N N N
H O
NH H2O
O S
MM3512.00 Argatroban Monohydrate 141396-28-3 250mg H
N

Arginine
N H2
H

MM0568.00 Arginine 74-79-3 500mg H 2N N OH

NH O

N H2
MM1521.00- Impurity A (EP) as Hydrochloride: (2S)-2,6-Diaminohexanoic H2 N
O H HCl
657-27-2 250mg
0250 Acid Hydrochloride (L-Lysine Hydrochloride) O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-40
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N H2
Impurity B (EP): (2S)-2-Amino-5-(carbamoylamino)pentanoic H 2N
H
N OH
MM0568.01 372-75-8 100mg
Acid (Citrulline; L-Citrulline) O O

Impurity C (EP) as Hydrochloride: (2S)-2,5-


Diaminopentanoic Acid Hydrochloride (L-Ornithine NH2
H 2N OH
MM1565.00 Hydrochloride) 3184-13-2 250mg
O
HCl

Arginine Aspartate
N H2
H
H2 N N OH

NH O
MM3575.00 Arginine Aspartate (L-Arginine L-Aspartate) 7675-83-4 250mg O NH2
OH
HO
O

Arginine Hydrochloride
NH2
H

MM0569.00 Arginine Hydrochloride 1119-34-2 500mg H2 N

NH
N

O
OH HCl

N H2
H
H 2N N OH
MM0568.00 Arginine (L-Arginine) 74-79-3 500mg
NH O

N H2
MM1521.00- Impurity A (EP) as Hydrochloride: (2S)-2,6-Diaminohexanoic H2 N
O H HCl
657-27-2 250mg
0250 Acid Hydrochloride (L-Lysine Hydrochloride) O

N H2
Impurity B (EP): (2S)-2-Amino-5-(carbamoylamino)pentanoic H 2N
H
N OH
MM0568.01 372-75-8 100mg
Acid (Citrulline) O O

NH2
Impurity C (EP) as Hydrochloride: (2S)-2,5- H 2N OH
MM1565.00 Diaminopentanoic Acid Hydrochloride (L-Ornithine 3184-13-2 250mg
O
Hydrochloride) HCl

Aripiprazole
H
O N O
N
MM0961.00-
Aripiprazole 129722-12-9 250mg
N

Cl
0250 Cl

H
MM0961.13- HO N O
Impurity A (EP): 7-Hydroxy-3,4-dihydroquinolin-2(1H)-one 22246-18-0 25mg
0025

Impurity B (EP) as Hydrochloride: 1-(2,3-Dichlorophenyl) NH

MM0961.02- piperazine Hydrochloride N


HCl
119532-26-2 25mg
0025 Related compound C (USP): 1-(2,3-dichlorophenyl) Cl
Cl
piperazine
H
O N O
MM0961.16- Impurity C (EP): 7-[4-[4-(2-Chlorophenyl)piperazin-1-yl] N
N
203395-81-7 25mg
Cl
0025 butoxy]-3,4-dihydroquinolin-2(1H)-one
H
O N O
N
Impurity D (EP): 7-[4-[4-(3-Chlorophenyl)piperazin-1-yl] N

MM0961.07 203395-82-8 100mg


butoxy]-3,4-dihydroquinolin-2(1H)-one Cl

H
O N O
N
MM0961.07- Impurity D (EP): 7-[4-[4-(3-Chlorophenyl)piperazin-1-yl] N

203395-82-8 25mg
0025 butoxy]-3,4-dihydroquinolin-2(1H)-one Cl

Impurity E (EP): 7-[4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]


H
O N O
N
MM0961.04- butoxy]quinolin-2(1H)-one N

129722-25-4 25mg Cl
0025 Related compound G (USP): 7-4-[4-(2,3-dichlorophenyl) Cl

piperazin-1-yl]butoxyquinolin-2(1H)-one

Impurity F (EP): 7-[4-[4-(2,3-Dichlorophenyl)-1-


O H
+ O N O
N
MM0961.03- oxidopiperazin-1-yl]butoxy]-3,4-dihydroquinolin-2(1H)-one N

573691-09-5 25mg Cl
0025 (Aripiprazole N-Oxide) Cl

Related compound F (USP): 4-(2,3-dichlorophenyl)-1-[4-(2-oxo-

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-41
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0961.01- 7-(4-Hydroxybutoxy)-3,4-dihydroquinolin-2(1H)-one O
H
N O

Related compound B (USP): 7-(4-hydroxy-butoxy)-3,4- 889443-20-3 25mg HO

0025 dihydroquinolin-2(1H)-one
7-(4-[4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy]butoxy)-
O
MM0961.05- 3,4-dihydroquinolin-2(1H)-one N
N O N
H
O

n/a 25mg Cl

0025 Related compound H (USP): 7-(4-4-[4-(2,3-dichlorophenyl) Cl

piperazin-1-yl]butoxybutoxy)-3,4-dihydroquinolin-2(1H)-one
H
O N O
Cl
MM0961.06 7-(4-Chlorobutoxy)-3,4-dihydro-2(1H)-quinolinone 120004-79-7 100mg

H
MM0961.06- O N O
Cl
7-(4-Chlorobutoxy)-3,4-dihydro-2(1H)-quinolinone 120004-79-7 25mg
0025
H
MM0961.08- HO N O
7-Hydroxy-2(1H)-quinolinone 70500-72-0 25mg
0025
H
O N O
Br
MM0961.09 7-(4-Bromobutoxy)-3,4-dihydro-2(1H)-quinolinone 129722-34-5 100mg

H
MM0961.09- O N O
Br
7-(4-Bromobutoxy)-3,4-dihydro-2(1H)-quinolinone 129722-34-5 25mg
0025
O NH2

MM0961.10 3-Methoxyaniline 536-90-3 100mg

H
MM0961.15- O N O
N-(3-Methoxyphenyl)prop-2-enamide 17208-99-0 25mg
0025
H
MM0961.19- O N O
I
7-(4-Iodobutoxy)-3,4-dihydro-2(1H)-quinolinone 952308-47-3 25mg
0025
H
MM0961.20- O N O
Br
7-(4-Bromobutoxy)-2(1H)-quinolinone 203395-59-9 25mg
0025
O
H
MM0961.25- HO
O N O
4-[(2-Oxo-3,4-dihydroquinolin-7(1H)-yl)oxy]butanoic Acid 58899-27-7 25mg
0025
H
O N O
N
MM0961.30- 7-[4-[4-(3,4-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4- N

203395-75-9 25mg Cl
0025 dihydro-2(1H)-quinolinone Cl

Arprinocid
N H2

N
N
Cl
MM3689.00 Arprinocid 55779-18-5 250mg N N

Artemether

O
O H
O
MM3252.00 Artemether 71963-77-4 250mg H H
O

-Artemether ((3R,5aS,6R,8aS,9R,10R,12R,12aR)-
Decahydro-10-methoxy-3,6,9-trimethyl-3,12-epoxy-12H- O
pyrano[4,3-j]-1,2-benzodioxepin) O H
MM3252.02- O
Related compound B (USP): 71939-51-0 25mg H H
0025 (3R,5aS,6R,8aS,9R,10R,12R,12aR)-Decahydro-10-methoxy- O

3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]-1,2- O
benzodioxepin

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-42
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Artesunate

O
Anhydrodihydroartemisinin O H
MM3253.01 82596-30-3 100mg O
Related compound C (USP): Anhydrodihydroartemisinin H H
O

O
MM3253.01- Anhydrodihydroartemisinin O H
82596-30-3 25mg O
0025 Related compound C (USP): Anhydrodihydroartemisinin H H
O

Articaine Hydrochloride
O
O
H

MM0369.00 Articaine Hydrochloride 23964-57-0 250mg S


N

O
N
H
HCl

O
O
MM0369.11- H
N
Articaine 23964-58-1 250mg N
S H
0250 O

Impurity A (EP) as Hydrochloride: Methyl 3-[[2-


(Propylamino)acetyl]amino]-4-methyl- O HCl

thiophene-2-carboxylate Hydrochloride O
H
N
N
(Acetamidoarticaine Hydrochloride)
MM0369.01 n/a 100mg S H
O

Related compound A (USP): Methyl 4-methyl-3-[2-


(propylamino)acetamido]thiophene-2-carboxylate
Impurity A (EP) as Hydrochloride: Methyl 3-[[2-
(Propylamino)acetyl]amino]-4-methyl- O HCl
MM0369.01- thiophene-2-carboxylate Hydrochloride O
H
N
N
(Acetamidoarticaine Hydrochloride)
n/a 25mg S H
0025 O

Related compound A (USP): Methyl 4-methyl-3-[2-


(propylamino)acetamido]thiophene-2-carboxylate
Impurity B (EP) as Hydrochloride: 4-Methyl-3-
[[(2RS)-2-(propylamino)propanoyl]amino]- O HCl
HO
thiophene-2-carboxylic Acid Hydrochloride H
N
N
MM0369.02
(Articaine Acid Hydrochloride)
n/a 50mg S H
O

Related compound B (USP): 4-methyl-3-[2-(propylamino)


propanoyl]aminothiophene-2-carboxylic acid
Impurity C (EP) as Hydrochloride: 1-Methyl-
ethyl 4-Methyl-3-[[(2RS)-2-(propylamino)- O
O
H
HCl

MM0369.03 propanoyl]amino]thiophene-2-carboxylate n/a 100mg S


N

O
N
H

Hydrochloride (Articaine Isopropyl Ester


Hydrochloride)
Impurity C (EP) as Hydrochloride: 1-Methyl-
MM0369.03- ethyl 4-Methyl-3-[[(2RS)-2-(propylamino)- O
O
H
HCl

propanoyl]amino]thiophene-2-carboxylate n/a 25mg S


N

O
N
H
0025 Hydrochloride (Articaine Isopropyl Ester
Hydrochloride)
Impurity D (EP) as Hydrochloride: Methyl O
MM0369.04- 3-[[(2RS)-2-(Ethylamino)propanoyl]amino]- O
H
N
N HCl
2602451-79-4 25mg
4-methylthiophene-2-carboxylate
S H
O
0025
Hydrochloride (Ethylarticaine Hydrochloride)

MM0369.04- Impurity D (EP) as Hydrochloride: Methyl 3-[[(2RS)-2- O


O
H

(Ethylamino)propanoyl]amino]-4-methylthiophene-2- 2602451-79-4 100mg S


N

O
N
H
HCl

0100 carboxylate Hydrochloride (Ethylarticaine Hydrochloride)


Impurity E (EP): Methyl 4-Methyl-3-[[(2RS)-2-[(1-methylethyl)
amino]propanoyl]amino]thiophene-2-carboxylate O
O
MM0369.13- H
N
(Isopropylarticaine) 1796888-45-3 25mg N
S H
0025 O
Related compound E (USP): Methyl 3-[2-(isopropylamino)
propanamido]-4-methylthiophene-2-carboxylate

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-43
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity E (EP) as Hydrochloride: Methyl


4-Methyl-3-[[(2RS)-2-[(1-methylethyl)amino]-
propanoyl]amino]thiophene-2-carboxylate O
O
H HCl

MM0369.05 Hydrochloride (Isopropylarticaine n/a 100mg S


N

O
N
H

Hydrochloride)
Related compound E (USP): Methyl 3-[2-(isopropylamino)
propanamido]-4-methylthiophene-2-carboxylate
Impurity E (EP) as Hydrochloride: Methyl
4-Methyl-3-[[(2RS)-2-[(1-methylethyl)amino]-
MM0369.05- propanoyl]amino]thiophene-2-carboxylate O
O
H HCl

Hydrochloride (Isopropylarticaine n/a 25mg S


N

O
N
H
0025 Hydrochloride)
Related compound E (USP): Methyl 3-[2-(isopropylamino)
propanamido]-4-methylthiophene-2-carboxylate
Impurity F (EP) as Hydrochloride: 4-Methyl-
N-propyl-3-[[(2RS)-2-(propylamino)- H
N
O
H
HCl

MM0369.06 propanoyl]amino]thiophene-2-carboxamide n/a 50mg S


N

O
N
H

Hydrochloride (Articaine Acid Propionamide


Hydrochloride)
Impurity G (EP) as Hydrochloride: Methyl
O
MM0369.07- 3-[[(2RS)-2-(Butylamino)propanoyl]amino]-4- O
H
N
N
HCl
23964-59-2 25mg S

0025 methylthiophene-2-carboxylate Hydro- O


H

chloride (Butylarticaine Hydrochloride)


Impurity H (EP) as Hydrochloride: Methyl
MM0369.08- 3-[[(2RS)-2-(Dipropylamino)propanoyl]- O
O
H
HCl

amino]-4-methylthiophene-2-carboxylate n/a 25mg S


N
N
O
0025 Hydrochloride (Dipropylarticaine
Hydrochloride)
O
Impurity I (EP): Methyl 3-Amino-4- O
N H2
MM0369.09 methylthiophene-2-carboxylate 85006-31-1 100mg
S
(3-Aminoarticaine)

O
Impurity I (EP): Methyl 3-Amino-4- O
MM0369.09- N H2
methylthiophene-2-carboxylate 85006-31-1 25mg
S
0025 (3-Aminoarticaine)

Impurity J (EP): Methyl 3-[[(2RS)-2- O


O
Br
MM0369.10- Bromopropanoyl]amino]-4- H
N
1160919-46-9 25mg
0025 methylthiophene-2-carboxylate S
O
(Bromo Compound)

Ascorbic Acid
OH
O
O
MM0166.00 L-Ascorbic Acid 50-81-7 500mg HO H

HO OH

O
MM0397.02- Impurity A (EP): 2-Furaldehyde (Furane-2-carbaldehyde, O
98-01-1 500mg
0500 Furfural)

O OH
OH
MM0166.08- Impurity C (EP) as Monohydrate: L-xylo-Hex-2-ulosonic Acid HO H2O
219905-82-5 25mg O
0025 Monohydrate (L-Sorbosonic Acid Monohydrate) OH
HO

O O
OH
MM0166.09- Impurity D (EP): Methyl L-xylo-Hex-2-ulosonate (Methyl L- HO
3031-98-9 25mg O
0025 Sorbosonate) OH
HO

O OH
MM0928.01 Impurity E (EP): Oxalic Acid 144-62-7 500mg
O OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-44
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O OH
H 2O
MM0928.00 Impurity E (EP) as Dihydrate: Oxalic Acid Dihydrate 6153-56-6 500mg 2
O OH

OH
O
MM0166.10- Impurity F (EP): (5R)-5-[(1R)-1,2-Dihydroxyethyl]-3,4- O
89-65-6 100mg HO H
0100 dihydroxyfuran-2(5H)-one (D-Isoascorbic Acid)
HO OH

O OH
MM0166.05- HO
L-(-)-Sorbose 87-79-6 25mg OH
0025 OH OH

Ascorbyl Palmitate
OH
O O O
H
MM1999.00- O
Ascorbyl Palmitate 137-66-6 250mg HO OH

0250

Asenapine Maleate
AND Enantiomer

N O

MM3491.00 Asenapine Maleate 85650-56-2 250mg H H OH


Cl OH

O O

Asparagine Monohydrate
O N H2

MM0765.00 Asparagine Monohydrate (L-Asparagine Monohydrate) 5794-13-8 250mg H2 N


OH H2O

O NH2
Impurity A (EP): (2S)-2-Aminobutanedioic Acid (Aspartic OH
MM0567.00 56-84-8 500mg HO
Acid) O

NH2
Impurity B (EP): (2S)-2-Aminopentanedioic Acid (Glutamic HO OH
MM1333.00 56-86-0 250mg
Acid) O O

O
MM0460.10- HO
Impurity D (EP): (2E)-But-2-enedioic Acid (Fumaric Acid) 110-17-8 250mg OH
0250 O

NH2
MM0169.00- Impurity E (EP): (2S)-2,5-Diamino-5-oxopentanoic Acid (L- H 2N OH
56-85-9 250mg
0250 Glutamine) O O

MM0765.01- O HN
Phenylacetylasparagine 2752-49-0 25mg OH
0025 H 2N
O

Aspartame
O N H2 O
H
N
HO O

MM0314.00 Aspartame 22839-47-0 500mg O

Impurity A (EP): 2-(5-Benzyl-3,6-


O

MM0314.01- dioxopiperazin-2-yl)acetic Acid O HN


(Diketopiperazine) 5262-10-2 25mg HO
NH
0025 Related compound A (USP): [(2S,5S)-5-Benzyl-3,6- O

dioxopiperazin-2-yl]acetic acid
O N H2 O
H
N
HO OH

MM0314.02 Impurity B (EP): L-Aspartyl-L-phenylalanine 13433-09-5 100mg O

O N H2 O
H
N
MM0314.02- HO OH
Impurity B (EP): L-Aspartyl-L-phenylalanine 13433-09-5 25mg O
0025

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-45
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

NH2
Impurity C (EP): (2S)-2-Amino-3-phenylpropanoic Acid (L- OH
MM1560.00 63-91-2 250mg
Phenylalanine)
O

NH2
Impurity C (EP) as Racemate: 2-Amino-3-phenylpropanoic OH
MM0314.03 150-30-1 100mg
Acid (Phenylalanine)
O

NH2
MM0314.03- Impurity C (EP) as Racemate: 2-Amino-3-phenylpropanoic OH
150-30-1 25mg
0025 Acid (Phenylalanine)
O

H
N O

MM0314.04 Piperazine-2,5-dione (Glycine Anhydride) 106-57-0 100mg


O N
H

H
N O
MM0314.04-
Piperazine-2,5-dione (Glycine Anhydride) 106-57-0 25mg
0025
O N
H

O
MM0314.06- O HCl
L-Phenylalanine Methyl Ester Hydrochloride 7524-50-7 25mg NH2
0025

Aspartic Acid
O NH2
OH
MM0567.00 Aspartic Acid 56-84-8 500mg HO
O

O
Impurity A (EP): (2RS)-2-Hydroxybutanedioic Acid (Malic HO
MM1332.00 6915-15-7 250mg OH
Acid) O OH

O
MM0460.10- HO
Impurity B (EP): (2E)-But-2-enedioic Acid (Fumaric Acid) 110-17-8 250mg OH
0250 O

NH2
Impurity C (EP): (2S)-2-Aminopentanedioic Acid (Glutamic HO OH
MM1333.00 56-86-0 250mg
Acid) O O

NH2
OH
MM0566.00 Impurity D (EP): (2S)-2-Aminopropanoic Acid (Alanine) 56-41-7 500mg
O

O
MM0567.05- HO
Impurity E (EP): Butanedioic Acid (Succinic Acid) 110-15-6 100mg OH
0100 O

NH2
MM0169.00- Impurity F (EP): (2S)-2,5-Diamino-5-oxopentanoic Acid (L- H 2N OH
56-85-9 250mg
0250 Glutamine) O O

O N H2
Impurity G (EP) as Monohydrate: (2S)-2,4-Diamino-4- OH H2O
MM0765.00 5794-13-8 250mg H2 N
oxobutanoic Acid Monohydrate (Asparagine Monohydrate) O

MM1439.00- OH
Impurity H (EP): (2Z)-But-2-enedioic Acid (Maleic Acid) 110-16-7 250mg
0250 OH

Aspirin, see Acetylsalicylic Acid

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-46
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Atazanavir Sulfate
N

MM3514.00 Atazanavir Sulfate 229975-97-7 100mg O


O

N
H
O
H
N
OH
N
N
H
O
H
N

O
O
HO
O
S
O

OH

MM3514.06-
Impurity B (EP): 4-(Pyridin-2-yl)benzaldehyde 127406-56-8 25mg
0025
N

Impurity J (EP): tert-Butyl 2-[(2S,3S)-3-(tert-


N
Butoxyformamido)-2-hydroxy-4-phenylbutyl]-2-[[4-(pyridin-2-
OH O
MM3514.02 yl)phenyl]methyl]hydrazine-1-carboxylate (tert-Butyl N- 198904-86-8 100mg H
O N N
N O
H
O
[(1S,2S)-1-Benzyl-3-[(tert-butoxycarbonylamino)-[[4-(2-
pyridyl)phenyl]methyl]amino]-2-hydroxy-propyl]carbamate)
Impurity J (EP): tert-Butyl 2-[(2S,3S)-3-(tert-
N
Butoxyformamido)-2-hydroxy-4-phenylbutyl]-2-[[4-(pyridin-2-
MM3514.02- OH O
yl)phenyl]methyl]hydrazine-1-carboxylate (tert-Butyl N- 198904-86-8 25mg H
O N N
0025 N O
H
O
[(1S,2S)-1-Benzyl-3-[(tert-butoxycarbonylamino)-[[4-(2-
pyridyl)phenyl]methyl]amino]-2-hydroxy-propyl]carbamate)
Impurity K (EP): (2S)-2-(Methoxyformamido)-3,3-
dimethylbutanoic Acid ((S)-2-(Methoxycarbonylamino)-3,3- O
MM3514.03-
dimethylbutanoic Acid) 162537-11-3 25mg OH
0025 O N
H
Related compound A (USP): (S)-2-[(Methoxycarbonyl) O

amino]-3,3-dimethylbutanoic acid

Atenolol
OH
H
O N

MM0013.00 Atenolol 29122-68-7 500mg H2 N


O

OH
Impurity A (EP): 2-(4-Hydroxyphenyl)- O
MM0013.03 17194-82-0 100mg
acetamide H2 N

OH
MM0013.03- Impurity A (EP): 2-(4-Hydroxyphenyl)- O
17194-82-0 25mg
0025 acetamide H2 N

Impurity B (EP): 2-[4-[(2RS)-2,3-Dihydroxy-


OH
propoxy]phenyl]acetamide O
O OH
MM0013.05
Related compound A (USP): 2-[4-(2,3-Dihydroxypropoxy)
61698-76-8 100mg
H2 N

phenyl]acetamide
Impurity B (EP): 2-[4-[(2RS)-2,3-Dihydroxy-
OH
MM0013.05- propoxy]phenyl]acetamide O
O OH

Related compound A (USP): 2-[4-(2,3-Dihydroxypropoxy)


61698-76-8 25mg
0025 H2 N

phenyl]acetamide
O
2-[4-[[(2RS)-Oxiran-2-yl]methoxy]phenyl]- O
O

acetamide
MM0013.01 29122-69-8 100mg H 2N

O
MM0013.01- 2-[4-[[(2RS)-Oxiran-2-yl]methoxy]phenyl]- O
O

acetamide
29122-69-8 25mg
0025 H 2N

OH
MM0013.06- Impurity D (EP): 2-[4-[(2RS)-3-Chloro-2- O
O Cl
115538-83-5 25mg
0025 hydroxypropoxy]phenyl]acetamide H2 N

Impurity E (EP): 2,2'-[(2-Hydroxypropane-1,3-


MM0013.07- diyl)bis(oxy-4,1-phenylene)]diacetamide O
O
OH
O
O

Related compound E (USP): 2,2'-[(2-Hydroxypropane-1,3-


141650-31-9 25mg H 2N NH2

0025
diyl)bis(oxy)]bis(4,1-phenylene)diacetamide
Impurity F (EP): 2,2'-[[(1-Methylethyl)-
imino]bis[(2-hydroxypropane-3,1- OH OH

MM0013.02 diyl)oxy-4,1-phenylene]]diacetamide 87619-83-8 50mg H 2N


O
O N O
O

N H2

Related compound D (USP): N-Isopropyl-N,N-bis3-[4-(2-


amino-2-oxoethyl)phenoxy]-2-hydroxyprop-1-ylamine

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-47
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity G (EP): 2-[4-[(2RS)-2-Hydroxy-3-


[(1-methylethyl)amino]propoxy]phenyl]- OH
H
O N
MM0013.04 acetic Acid 56392-14-4 50mg HO
O

Related compound C (USP): 2-4-[2-hydroxy-3-


(isopropylamino)propoxy]phenyl acetic acid
Impurity H (EP): 2-[4-[(2RS)-2-Hydroxy-3-
[(1-methylethyl)amino]propoxy]phenyl]- OH
H
O N
MM0013.08 acetonitrile 29277-73-4 100mg N

Related compound B (USP): 2-4-[2-hydroxy-3-


(isopropylamino)propoxy]phenylacetonitrile
Impurity H (EP): 2-[4-[(2RS)-2-Hydroxy-3-
MM0013.08- [(1-methylethyl)amino]propoxy]phenyl]- OH
H
O N
acetonitrile 29277-73-4 25mg N

0025 Related compound B (USP): 2-4-[2-hydroxy-3-


(isopropylamino)propoxy]phenylacetonitrile
Impurity I (EP): 2-[4-[(2RS)-3-(Ethylamino)-2-
OH
hydroxypropoxy]phenyl]acetamide O
O
H
N

Related compound E (USP): 2-4-[3-(ethylamino)-2-


MM0013.17 1797116-92-7 50mg H2 N

hydroxypropoxy]phenylacetamide
Impurity J (EP): 2-[4-[(2RS)-3-Amino-2-hydroxypropoxy] OH
MM0013.18- O
O N H2

phenyl]acetamide (N-Desisopropylatenolol) 81346-71-6 25mg


0025 H 2N

O
O
MM0013.09 2-[4-[(Oxiran-2-yl)methoxy]phenyl]acetonitrile 35198-42-6 100mg N

O
MM0013.09- O
2-[4-[(Oxiran-2-yl)methoxy]phenyl]acetonitrile 35198-42-6 25mg N
0025
OH
O Cl
MM0013.10 2-[4-(3-Chloro-2-hydroxypropoxy)phenyl]acetonitrile 142037-04-5 100mg N

O
O

MM0013.11 4-(2,3-Epoxypropoxy)phenylacetic Acid 72224-25-0 100mg O

HO

O
MM0013.11- O

4-(2,3-Epoxypropoxy)phenylacetic Acid 72224-25-0 25mg O

0025 HO

OH
O
MM0013.13 4-Hydroxyphenylacetic Acid 156-38-7 100mg
HO

OH
MM0013.13- O
4-Hydroxyphenylacetic Acid 156-38-7 25mg
0025 HO

OH
O
MM0013.14 Methyl 4-Hydroxyphenylacetate 14199-15-6 100mg
O

OH
MM0013.14- O
Methyl 4-Hydroxyphenylacetate 14199-15-6 25mg
0025 O

Atomoxetine Hydrochloride

MM1304.00 Atomoxetine Hydrochloride 82248-59-7 250mg HCl

O N
H

OH
MM1304.05- Impurity E (EP): (2S)-2-Hydroxy-2-phenylacetic Acid (L- OH
17199-29-0 25mg
0025 Mandelic Acid) O

OH

MM0256.01 Impurity H (EP): (1RS)-3-(Methylamino)-1-phenylpropan-1-ol 42142-52-9 100mg N


H

OH
MM0256.01-
Impurity H (EP): (1RS)-3-(Methylamino)-1-phenylpropan-1-ol 42142-52-9 25mg N
H
0025

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-48
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

(1R)-3-(Methylamino)-1-phenylpropan-1-ol
MM1304.06 Related compound A (USP): 3-(Methylamino)-1- 115290-81-8 100mg
phenylpropan-1-ol HO N
H

(1R)-3-(Methylamino)-1-phenylpropan-1-ol
MM1304.06-
Related compound A (USP): 3-(Methylamino)-1- 115290-81-8 25mg
0025
phenylpropan-1-ol HO N
H

Atorvastatin Calcium Trihydrate


O

O OH O

N N OH

MM0400.00 Atorvastatin Calcium 134523-03-8 100mg H Ca


2+

F
2

Impurity D (EP): 3-[(4-Fluorophenyl)carbonyl]-


MM0400.11- 2-(2-methylpropanoyl)-N,3-diphenyloxirane-2-carbox- O

N O
amide 148146-51-4 25mg H O

F
0025 Related compound D (USP): Epoxide impurity, or 3-(4- O

Fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2-carboxylic

Impurity E (EP) as Calcium Salt: (3S,5S)-7-[2-(4-


Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4- O

O OH O

MM0400.28- (phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic N
H
N OH
Ca
2+

Acid Calcium Salt (ent-Atorvastatin Calcium Salt)


1105067-88-6 25mg
0025 F

Related compound E (USP): 3S, 5S enantiomer of 2

Atorvastatin
Impurity G (EP) as Calcium Salt: (3R,5R)-7-[2-(4-)-5-(1- O

methylethyl)-3-phenyl-4- N
O

N
OH

O
O

(phenylcarbamoyl)-1H-pyrrol-1-yl]-5-hydroxy- H 2+
Ca
MM0400.12 887196-29-4 100mg
-methoxyheptanoic Acid Calcium Salt F
2

(3-O-Methylatorvastatin Calcium Salt)


Impurity G (EP) as Calcium Salt: (3R,5R)-7-[2-(4-)-5-(1- O

MM0400.12- methylethyl)-3-phenyl-4- N
O

N
OH

O
O

(phenylcarbamoyl)-1H-pyrrol-1-yl]-5-hydroxy- H 2+
Ca
887196-29-4 25mg
0025 -methoxyheptanoic Acid Calcium Salt F
2

(3-O-Methylatorvastatin Calcium Salt)


Impurity H (EP): (4R,6R)-6-[2-[2-(4-Fluorophenyl)-
5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-
1H-pyrrol-1-yl]ethyl]-4-hydroxytetrahydro-2H- O O
O

pyran-2-one (Atorvastatin Lactone) N


H
N OH

Related compound H (USP): Lactone Impurity, 5-(4-


MM0400.01 125995-03-1 100mg
Fluorophenyl)-1-2-[(2R, 4R)-4-hydroxy-6-oxotetrahydro-2H- F

pyran-2-yl]ethyl-2-isopropyl-N,4-diphenyl-1H-pyrrole-3-
carboxamide
Impurity H (EP): (4R,6R)-6-[2-[2-(4-Fluorophenyl)-
5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-
1H-pyrrol-1-yl]ethyl]-4-hydroxytetrahydro-2H- O O
O

MM0400.01- pyran-2-one (Atorvastatin Lactone) N


H
N OH

Related compound H (USP): Lactone Impurity, 5-(4-


125995-03-1 25mg
0025
Fluorophenyl)-1-2-[(2R, 4R)-4-hydroxy-6-oxotetrahydro-2H- F

pyran-2-yl]ethyl-2-isopropyl-N,4-diphenyl-1H-pyrrole-3-
carboxamide
Impurity I (EP): tert-Butyl [(4R,6R)-6-[2-[2-(4-Fluorophenyl)-3-
phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]
ethyl]-2,2-dimethyl-1,3-dioxan-4-yl]acetate (1,1-Dimethylethyl
(4R-cis)-6-[2-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl- O O O O

MM0400.04- N
H
N O

4-[(phenylamino)carbonyl]-1-H-pyrrol-1-yl]ethyl]-2,2-di- 125971-95-1 25mg


0025 F
methyl-1,3-dioxane-4-acetate)
Related compound I (USP): tert-Butyl 2-((4R,6R)-6-2-[2-(4-
fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-
pyrrol-1-yl]ethyl-2,2-dimethyl-1,3-dioxan-4-yl)acetate

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-49
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity K (EP): Methyl (3R,5R)-7-[2-(4-Fluorophenyl)-3- O OH O

N N OH
H
MM0400.02 phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]- 345891-62-5 100mg
3,5-dihydroxyheptanoate (Atorvastatin Methyl Ester) F

Impurity K (EP): Methyl (3R,5R)-7-[2-(4-Fluorophenyl)-3- O OH O

MM0400.02- N
H
N OH

phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]- 345891-62-5 25mg


0025
3,5-dihydroxyheptanoate (Atorvastatin Methyl Ester) F

Impurity M: Ethyl (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4- O OH O

N N OH
H
MM0400.30 (phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5- 1146977-93-6 100mg
dihydroxyheptanoate (Atorvastatin Ethyl Ester) F

Impurity M: Ethyl (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4- O OH O

MM0400.30- N
H
N OH

(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5- 1146977-93-6 25mg


0025
dihydroxyheptanoate (Atorvastatin Ethyl Ester) F

Impurity N (EP): tert-Butyl (3R,5R)-7-[2-(4-Fluorophenyl)-3- O OH O

MM0400.35- N
H
N OH

phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]- 134395-00-9 25mg


0025
3,5-dihydroxyheptanoate (Atorvastatin tert-Butyl Ester) F

Impurity P (EP): [(4R,6R)-6-[2-[2-(4-Fluorophenyl)-3-phenyl- O O O O

MM0400.41- N N OH
H

4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl]-2,2- 581772-29-4 25mg


0025
F
dimethyl-1,3-dioxan-4-yl]acetic Acid (Atorvastatin Acetonide)
1,1-Dimethylethyl (4R-cis)-6-Aminoethyl-2,2- O O O
MM0400.05
dimethyl-1,3-dioxane-4-acetate
125995-13-3 100mg
H2 N O

1-[2-[(2S)-3,6-Dihydro-6-oxo-2H-pyran-2-yl]- O O

ethyl]-5-(4-fluorophenyl)-2-(1-methylethyl)- N
H
N

N,4-diphenyl-1H-pyrrole-3-carboxamide
MM0400.13 442851-50-5 100mg
(Atorvastatin eliminated Lactone) F

1-[2-[(2S)-3,6-Dihydro-6-oxo-2H-pyran-2-yl]- O O

MM0400.13- ethyl]-5-(4-fluorophenyl)-2-(1-methylethyl)- N
H
N

N,4-diphenyl-1H-pyrrole-3-carboxamide
442851-50-5 25mg
0025
(Atorvastatin eliminated Lactone) F

O OH O

MM0400.31- N
H
N OH

Atorvastatin Isopropyl Ester 1035205-25-4 25mg


0025
F

O
MM0400.32 4-Methyl-3-oxo-N-phenylpentanamide 124401-38-3 100mg N O
H

O
MM0400.32-
4-Methyl-3-oxo-N-phenylpentanamide 124401-38-3 25mg N O
0025 H

MM0400.33- N O
2-Benzylidene-4-methyl-3-oxo-N-phenylpentanamide 125971-57-5 25mg H
0025

MM0400.37- 1,1-Dimethylethyl 2-[(4R,6R)-6-(Cyanomethyl)-2,2-dimethyl- O O O


125971-94-0 25mg N
0025 1,3-dioxan-4-yl]acetate O

O O
2-[2-(4-Fluorophenyl)-2-oxo-1-phenylethyl]-4-methyl-3-oxo-N- O
N
MM0400.03 phenylpentanamide (4-Fluoro-a-(2-methyl-1-oxopropyl)-?- 125971-96-2 100mg H

oxo-N,ß-diphenylbenzenebutanamide)
F

O O
2-[2-(4-Fluorophenyl)-2-oxo-1-phenylethyl]-4-methyl-3-oxo-N- O
MM0400.03- N
phenylpentanamide (4-Fluoro-a-(2-methyl-1-oxopropyl)-?- 125971-96-2 25mg H
0025
oxo-N,ß-diphenylbenzenebutanamide)
F

O OH NH2

MM0400.39- N
H
N OH

(3R,5R)-Atorvastatin Amide 2125501-02-0 25mg


0025
F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-50
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Atosiban Acetate
O

O
H
N
N
H
O

Atosiban Acetate
H2 N S O NH
S O
MM3515.00 O
914453-95-5 100mg H 2N
O
H
N
N
N
NH OH
H
N O H 2N
H O
O
O
O

OH

Atovaquone
Cl

MM3007.00 Atovaquone 95233-18-4 250mg


OH
O

Cl

MM3007.07-
trans-4-(4-Chlorophenyl)cyclohexanecarboxylic Acid 49708-81-8 25mg O
0025
OH

MM3007.08- 2-Chloronaphthalene-1,4-dione (2-Chloro-1,4-


1010-60-2 25mg
0025 naphthoquinone) Cl
O

Atracurium Besilate
O

+
N
O
O O
O
O O
O S
O

MM0858.00 Atracurium Besilate 64228-81-5 250mg O


O
2
O O

O +
N

O O
S
MM0858.13 Impurity J (EP): Methyl Benzenesulphonate 80-18-2 100mg O

Atropine
AND Enantiomer
H
O

MM0289.18 Atropine 51-55-8 250mg H


O
N

OH H

AND Enantiomer
H
MM0289.00-
Atropine Sulphate
O O
H
N HO S OH H2 O
5908-99-6 250mg O
O
OH H
0250 2

Impurity A (EP) as Hydrochloride: (1R,3r,5S)- H

8-Methyl-8-azabicyclo[3.2.1]oct-3-yl O
H
O
N
HCl
MM0289.01 5978-81-4 100mg
2-Phenylpropenoate Hydrochloride H

(Apoatropine Hydrochloride)
Impurity A (EP) as Hydrochloride: (1R,3r,5S)- H

MM0289.01- 8-Methyl-8-azabicyclo[3.2.1]oct-3-yl O
H
O
N
HCl
5978-81-4 25mg
0025 2-Phenylpropenoate Hydrochloride H

(Apoatropine Hydrochloride)
O
Impurity C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic
MM0601.03 552-63-6 100mg OH
Acid (Tropic Acid)
OH

O
MM0601.03- Impurity C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic
552-63-6 25mg OH
0025 Acid (Tropic Acid)
OH

Impurity F (EP) as Hydrobromide Trihydrate: Hyoscine


H
O HBr
H
N O
O
MM0546.00 6533-68-2 500mg
Hydrobromide Trihydrate
H2 O
H 3
OH H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-51
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0289.03 Atropic Acid 492-38-6 100mg OH

O
MM0289.03-
Atropic Acid 492-38-6 25mg OH
0025

AND Enantiomer
H
MM0289.19- O
H +
4574-60-1 25mg O N HCl
Atropine N-Oxide Hydrochloride O
0025 OH H

Avanafil
OH
N

N N

MM3313.00 Avanafil 330784-47-9 100mg Cl


N
H
N
O O N
H
N

Azacitidine
NH2

N N

O N
MM1259.00 Azacitidine 320-67-2 250mg
O OH

OH
OH

NH2

MM1259.02- 5-Azacytosine (4-Amino-1,3,5-triazin-2(1H)-one) N N


931-86-2 25mg
0025 Related compound A (USP): 4-Amino-1,3,5-triazin-2(1H)-one
O N
H
O

O
O
1-O-Acetyl-2,3,5-tri-O-benzoyl- -D-ribofuranose O
O
MM1259.03 Related compound B (USP): 1-O-Acetyl-2,3,5-tri-O-benzoyl- 6974-32-9 100mg O
O
O
Beta-D-ribofuranose
O

O
O
1-O-Acetyl-2,3,5-tri-O-benzoyl- -D-ribofuranose O
MM1259.03- O

Related compound B (USP): 1-O-Acetyl-2,3,5-tri-O-benzoyl- 6974-32-9 25mg O

0025 O
O
Beta-D-ribofuranose
O

NH

1- -D-Ribofuranosyl-3-guanylurea Picrate HN NH2 O OH O


+ +
N N
O NH O O

MM1259.04 Related compound C (USP): 1-beta-D-Ribofuranosyl-3- 4336-46-3 50mg O OH


+
N
O O
OH
guanylurea OH

O N N H2

MM1259.05- O N N
5'-O-Formylazacitidine n/a 25mg O
0025 O HO
OH

O
O O

O O
MM1259.06-
1,2,3,5-Tetra-O-acetyl- -D-ribofuranose 13035-61-5 25mg O
0025 O
O
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-52
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N H2

N N
4-Amino-1-[2,3-O-(1-methylethylidene)- -D-ribofuranosyl]- O N
MM1259.09-
1,3,5-triazin-2(1H)-one (2',3'-O-(1-methylethylidene) 65370-90-3 25mg
0025 O O
azacitidine)
O
OH

Azaperone
F

Azaperone
N
MM1164.00 1649-18-9 250mg O N

F
O
MM1164.01- +
N
Azaperone N-Oxide 66065-28-9 25mg O N

0025 N

Azapropazone
O
+
MM0245.06- N
4-Methyl-2-nitroaniline 89-62-3 25mg O
0025
NH2

Azathioprine
O
+
N
N O

MM1532.00 Azathioprine 446-86-6 250mg N S


H
N
N

N N

O
+
N
Impurity A (EP): 1-Methyl-4-nitro-1H-imidazol-5-amine N O
MM1532.07-
Related compound A (USP): 1-methyl-4-nitro-1H-imidazol-5- 4531-54-8 25mg
0025
amine N N H2

SH
H
MM1537.00- Impurity B (EP) as Monohydrate: 7H-Purine-6-thiol N
N
6112-76-1 250mg H2 O
0250 Monohydrate (Mercaptopurine Monohydrate) N
N

O
+
N N
O
MM1532.01 Impurity C (EP): 5-Chloro-1-methyl-4-nitro-1H-imidazole 4897-25-0 100mg
N
Cl

O
+
N N
MM1532.01- O
Impurity C (EP): 5-Chloro-1-methyl-4-nitro-1H-imidazole 4897-25-0 25mg
0025
N
Cl

O
+
N
MM1532.08- N O
Impurity D (EP): 1-Methyl-4-nitro-1H-imidazole-5-thiol 6339-54-4 25mg
0025
N SH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-53
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N
HN
MM1047.01 Impurity F (EP): 1,7-Dihydro-6H-purin-6-one (Hypoxanthine) 68-94-0 100mg
N N
H

N
MM1047.01- HN
Impurity F (EP): 1,7-Dihydro-6H-purin-6-one (Hypoxanthine) 68-94-0 25mg
0025
N N
H

O
+
N
Impurity G (EP): 6-[(1-Methyl-4-nitro-1H-imidazol-5-yl) N O

sulfanyl]-7H-purin-2-amine (Thiamiprine) N
MM1292.00 5581-52-2 100mg S
Related compound G (USP): 6-[(1-methyl-4-nitro-1H- H
N
N
imidazol-5-yl)thio]-9H-purin-2-amine
H 2N N N

O
+
N
N O

MM1532.04- N
7-Methylazathioprine 302840-04-6 25mg S
0025
N
N

N N

O
+
N
N O

N S
MM1532.05 9-Methylazathioprine 304441-06-3 100mg
N
N

N N

O
+
N
N O

MM1532.05- N S
9-Methylazathioprine 304441-06-3 25mg
0025 N
N

N N

O
+
N
N O

MM1532.06- 9-Acetylazathioprine (9-Acetyl-6-[(1-methyl-4-nitroimidazol-5- N S


304441-05-2 25mg N
0025 yl)thio]purine) N

N N

S
H
N
MM0865.00 Thioguanine 154-42-7 250mg HN

H 2N N N

Azelaic Acid
O O

MM0687.00 Azelaic Acid 123-99-9 500mg HO OH

Azelastine Hydrochloride
O
N
HCl
N
MM0362.00-
Azelastine Hydrochloride 79307-93-0 250mg N

0250
Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-54
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0362.04 Impurity A (EP): Benzoyldiazane (Benzohydrazide) 613-94-5 100mg NH


NH2

O
MM0362.04-
Impurity A (EP): Benzoyldiazane (Benzohydrazide) 613-94-5 25mg NH
0025 NH2

Impurity B (EP) as Dihydrochloride: 1-Benzoyl-2-[(4RS)-


1-methylhexahydro-1H-azepin-4-yl]diazane N
H
MM0362.07 Dihydrochloride 2731998-18-6 100mg N
N
H HCl
O 2

Related compound B (USP): N'-(1-methylazepan-4-yl)


benzohydrazide
Impurity B (EP) as Dihydrochloride: 1-Benzoyl-2-[(4RS)-
1-methylhexahydro-1H-azepin-4-yl]diazane N
MM0362.07- H
Dihydrochloride 2731998-18-6 25mg N
N
H HCl
O 2
0025 Related compound B (USP): N'-(1-methylazepan-4-yl)
benzohydrazide
O

OH
O
MM0362.05 Impurity C (EP): 2-[(4-Chlorophenyl)acetyl]benzoic Acid 53242-76-5 100mg

Cl

OH
MM0362.05- O
Impurity C (EP): 2-[(4-Chlorophenyl)acetyl]benzoic Acid 53242-76-5 25mg
0025

Cl

NH
Impurity D (EP): 4-(4-Chlorobenzyl)phthalazin-1(2H)-one N
MM0362.01 Related compound D (USP): 4-(4-chlorobenzyl)phthalazin-1 53242-88-9 100mg
(2H)-one
Cl

NH
Impurity D (EP): 4-(4-Chlorobenzyl)phthalazin-1(2H)-one N
MM0362.01-
Related compound D (USP): 4-(4-chlorobenzyl)phthalazin-1 53242-88-9 25mg
(2H)-one
0025

Cl

Impurity E (EP): 3-(4-Chlorobenzylidene)isobenzofuran-1 Cl

(3H)-one
Related compound E (USP): 3-(4-chlorobenzylidene)
MM0362.08 20526-97-0 100mg O

isobenzofuran-1(3H)-one O

Impurity E (EP): 3-(4-Chlorobenzylidene)isobenzofuran-1 Cl

MM0362.08- (3H)-one
Related compound E (USP): 3-(4-chlorobenzylidene)
20526-97-0 25mg O
0025
isobenzofuran-1(3H)-one O

Impurity E (EP) as Z-Isomer: (Z)-3-(4-Chlorobenzylidene) O


MM0362.06 105279-16-1 100mg
isobenzofuran-1(3H)-one
Cl

MM0362.06- Impurity E (EP) as Z-Isomer: (Z)-3-(4-Chlorobenzylidene) O


105279-16-1 25mg
0025 isobenzofuran-1(3H)-one
Cl

HCl
MM0362.03 1-Methylazepan-4-one Hydrochloride 19869-42-2 100mg N
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-55
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Azilsartan
N
O O
N O
MM3924.00- HN N
Azilsartan 147403-03-0 250mg O OH
0250

Azithromycin
N
OH
HO HO
O O
O

MM1075.00 Azithromycin 83905-01-5 100mg OH O O


N O

HO O

H
N

OH
HO HO

Impurity A (EP): 6-Demethylazithromycin O O


O

MM1075.01 76801-85-9 100mg OH O O

(Azaerythromycin A) N O

HO O

OH

MM1075.03- Impurity F (EP): 3 -N-Demethyl-3 -N-formylazithromycin O O


HO HO

Related compound F (USP): 3'-N-demethyl-3'-N- 612069-28-0 25mg OH O O


O N
0025 formylazithromycin O

HO O

Impurity H (EP): 3 -N-[[4-(Acetylamino)phenyl]sulfonyl]-3 -N- N

OH
HO HO

MM1075.11- demethylazithromycin H
N
O O
O

OH O O

Related compound H (USP): 3'-N-[[4-(acetylamino)phenyl]


612069-30-4 25mg O
S
N O
0025 O O

sulfonyl]-3'-N-demethylazithromycin HO O

N
OH
HO HO
O O
MM1075.10- O

Impurity L (EP): Azithromycin 3 -N-Oxide 90503-06-3 25mg +


OH O O

0025 N O
O

HO O

Azorubine
O O
S
OH O
+
N Na
MM3706.00- N
Azorubine 3567-69-9 250mg
0250 O S +
O Na
O

Baclofen
H2 N
O

MM1235.00 Baclofen 1134-47-0 250mg OH

Cl

Impurity A (EP): (4RS)-4-(4-Chlorophenyl)pyrrolidin-2-one H


N
(Baclofen Lactam) O
MM1235.02 22518-27-0 100mg
Related compound A (USP): 4-(4-Chlorophenyl)-2-
Cl
pyrrolidinone
Impurity A (EP): (4RS)-4-(4-Chlorophenyl)pyrrolidin-2-one H
N
MM1235.02- (Baclofen Lactam) O
22518-27-0 25mg
0025 Related compound A (USP): 4-(4-Chlorophenyl)-2-
Cl
pyrrolidinone
O

Impurity B (EP): (3RS)-5-Amino-3-(4-chlorophenyl)- H2 N O


MM1235.03 1141-23-7 100mg
5-oxopentanoic Acid OH

Cl

MM1235.03- Impurity B (EP): (3RS)-5-Amino-3-(4-chlorophenyl)- H2 N O


1141-23-7 25mg
0025 5-oxopentanoic Acid OH

Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-56
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HO O
MM1235.01 3-(4-Chlorophenyl)glutaric Acid 35271-74-0 100mg OH

Cl

MM1235.01- HO O
3-(4-Chlorophenyl)glutaric Acid 35271-74-0 25mg OH
0025
Cl

H 2N
O
MM1235.07- HCl
Baclofen Methyl Ester Hydrochloride 213407-11-5 25mg O

0025 Cl

H 2N
O
MM1235.08- HCl
204503-99-1 25mg O
Baclofen Ethyl Ester Hydrochloride
0025 Cl

H 2N
O
MM1235.09- HCl
1332869-11-0 25mg O
Baclofen Isopropyl Ester Hydrochloride
0025 Cl

NH
MM1235.11-
4-(4-Chlorophenyl)piperidine-2,6-dione 84803-46-3 25mg O
0025
Cl

O
MM1235.12-
4-(4-Chlorophenyl)tetrahydropyran-2,6-dione 53911-68-5 25mg O
0025
Cl

Bambuterol Hydrochloride
OH
H
N O N

MM0773.00 Bambuterol Hydrochloride 81732-46-9 100mg O

HCl
N O

OH
N O

Impurity D (EP): 5-[(1RS)-1-Hydroxyethyl]-1,3- O


MM0773.04 112935-93-0 100mg
phenylene Bis(dimethylcarbamate) N O

O
N O

Impurity E (EP): 5-Acetyl-1,3-phenylene Bis- O


MM0773.05 81732-48-1 100mg
(dimethylcarbamate) N O

O
N O

MM0773.05- Impurity E (EP): 5-Acetyl-1,3-phenylene Bis- O


81732-48-1 25mg
0025 (dimethylcarbamate) N O

Bamethan Sulfate
OH
H
O O

Bamethan Sulfate
N
S
MM1822.00 5716-20-1 100mg HO OH
HO
2

Bamifylline Hydrochloride
N OH
O

MM1823.00 Bamifylline Hydrochloride 20684-06-4 100mg N


N
HCl

O N N

O
+
N OH
O
MM1823.01- N
Bamifylline N-Oxide n/a 25mg N
0025 O N N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-57
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Barbital
H
O N O

MM1721.00 Barbital 57-44-3 CS 100mg NH

Barbital Sodium
H +
O N O Na

MM1652.00 Barbital Sodium 144-02-5 CS 100mg N

Baricitinib
O O
S
N

N N
MM3905.00-
Baricitinib 1187594-09-7 250mg N
0250
N

N N
H

Basic Butylated Methacrylate Copolymer


O

MM0753.01 Impurity A (EP): Butyl Methacrylate 97-88-1 100mg O

MM0753.02 Impurity B (EP): Methyl Methacrylate 80-62-6 100mg O

O
Impurity C (EP): 2-(Dimethylamino)ethyl N
MM0753.03 2867-47-2 100mg O
Methacrylate

Bazedoxifene Acetate
HO
OH
N

MM3342.00 Bazedoxifene Acetate 198481-33-3 50mg N


O

OH

Beclamide
O

MM1825.00 Beclamide 501-68-8 100mg N


H
Cl

Beclometasone Dipropionate
O

O
O O

MM0199.00 Beclometasone Dipropionate 5534-09-8 250mg HO


H
O

Cl H
O

Impurity A (EP): 9-Chloro-11 ,17-dihydroxy-16 - O

methyl-3,20-dioxopregna-1,4-dien-21-yl O
O

MM0199.02 Propanoate (Beclometasone 21-Propionate) 69224-79-9 100mg HO


H
OH

Related compound A (USP): 9-Chloro-11Beta,17-dihydroxy- O


Cl H

16Beta-methyl-3,20-dioxopregna-1,4-diene-21-yl propionate

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-58
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP): 9-Chloro-11 ,17-dihydroxy-16 - O

MM0199.02- methyl-3,20-dioxopregna-1,4-dien-21-yl O
O

Propanoate (Beclometasone 21-Propionate) 69224-79-9 25mg HO


H
OH

0025 Related compound A (USP): 9-Chloro-11Beta,17-dihydroxy- O


Cl H

16Beta-methyl-3,20-dioxopregna-1,4-diene-21-yl propionate
O
Impurity B (EP): 21-(Acetyloxy)-9-chloro-11 - O
O
O

MM0199.06 hydroxy-16 -methyl-3,20-dioxopregna-1,4- 5534-08-7 100mg HO O


H
dien-17-yl Propanoate (Beclometasone 21- Cl H

Acetate 17-Propionate) O

O
Impurity B (EP): 21-(Acetyloxy)-9-chloro-11 - O
O
O
MM0199.06- hydroxy-16 -methyl-3,20-dioxopregna-1,4- 5534-08-7 25mg HO O
H
0025 dien-17-yl Propanoate (Beclometasone 21- Cl H

Acetate 17-Propionate) O

Impurity C (EP): 9-Chloro-11 -hydroxy-16 -methyl- O


O
O

MM0199.05 3,20-dioxo-17-(propanoyloxy)-pregna-1,4-dien- n/a 100mg HO O

21-yl Butanoate (Beclometasone 21-Butyrate


H

Cl H

17-Propionate) O

Impurity C (EP): 9-Chloro-11 -hydroxy-16 -methyl- O


O
O

O
MM0199.05- 3,20-dioxo-17-(propanoyloxy)-pregna-1,4-dien- n/a 25mg HO O

21-yl Butanoate (Beclometasone 21-Butyrate


H
0025 Cl H

17-Propionate) O

Impurity H (EP): 9-Chloro-11 ,21-dihydroxy-16 - OH


O
methyl-3,20-dioxopregna-1,4-dien-17-yl HO O
O

MM0199.01 Propanoate (Beclometasone 17-Propionate) 5534-18-9 100mg H

Related compound H (USP): 9-Chloro-11Beta,17-dihydroxy- O


Cl H

16Beta-methyl-3,20-dioxopregna-1,4-diene-17-yl propionate
Impurity H (EP): 9-Chloro-11 ,21-dihydroxy-16 - OH
O

MM0199.01- methyl-3,20-dioxopregna-1,4-dien-17-yl HO O
O

Propanoate (Beclometasone 17-Propionate) 5534-18-9 25mg H

0025 Related compound H (USP): 9-Chloro-11Beta,17-dihydroxy- O


Cl H

16Beta-methyl-3,20-dioxopregna-1,4-diene-17-yl propionate
OH
O

MM0199.03 9-Chloro-11 ,17,21-trihydroxy-16 -methylpregna- HO


H
OH
4419-39-0 100mg
1,4-diene-3,20-dione (Beclometasone) Cl H
O

OH
O

MM0199.03- 9-Chloro-11 ,17,21-trihydroxy-16 -methylpregna- HO


H
OH
4419-39-0 25mg
0025 1,4-diene-3,20-dione (Beclometasone) Cl H
O

Bemegride
O

MM1747.00 Bemegride 64-65-3 100mg NH

Benactyzine Hydrochloride
OH O

MM1826.00 Benactyzine Hydrochloride 57-37-4 100mg O


HCl

OH O
MM1826.02-
Benactyzine N-Oxide 42771-70-0 25mg O
+
0025 N O

Benazepril Hydrochloride
O
H OH
N
MM1229.00- N
Benazepril Hydrochloride 86541-74-4 250mg HCl
O O
O

0250

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-59
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity B (EP) as (1R,3S)-Enantiomer Hydrochloride: [(3S)-


3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2-oxo-
MM1229.08- 2,3,4,5-tetrahydro-1H-1-benzazepin-1-yl]acetic Acid H
N
O
OH

Hydrochloride ((1R,3S)-Benazepril Hydrochloride)


N HCl
O
86541-77-7 25mg O O

0025 Related compound B (USP): (3S)-3-[[(1R)-1-


(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-
oxo-1H-1-benzazepine-1-acetic acid
Impurity C (EP): (2S)-2-[[(3S)-1-(Carboxymethyl)-2-oxo-
2,3,4,5-tetrahydro-1H-1-benzazepin-3-yl]amino]-4- O
H
MM0274.01- phenylbutanoic Acid (Benazeprilat) N
N
O
OH

Related compound C (USP): (3S)-3-[[(1S)-1-carboxy-3-


86541-78-8 25mg HO O
0025
phenylpropyl]amino-2,3,4,5-tetrahydro-2-oxo-1H-1-
benzazepine]-1-acetic acid
Impurity D (EP) as Hydrochloride: [(3S)-3-[[(1S)-3-
Cyclohexyl-1-(ethoxycarbonyl)propyl]amino]-2-oxo-2,3,4,5- HCl
O
MM1229.06- tetrahydro-1H-1-benzazepin-1-yl]acetic Acid Hydrochloride H
N
N
OH

O
Related compound D (USP): 3-(1-Ethoxycarbonyl-3-
n/a 25mg O O
0025
cyclohexyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-
(3S)-benzazepine-1-acetic acid
Impurity E (EP) as Hydrochloride: [(3S)-3-Amino-2-oxo-
O
2,3,4,5-tetrahydro-1H-1-benzazepin-1-yl]acetic Acid H 2N
N
OH
MM1229.07- HCl
Hydrochloride n/a 25mg O

0025 Related compound E (USP): 3-amino-2,3,4,5-tetrahydro-2-


oxo-1H-1-(3S)-benzazepine-1-acetic acid
Impurity F (EP): 1,1-Dimethylethyl [(3S)-3-Amino- O

MM1229.03- 2-oxo-2,3,4,5-tetrahydro-1H-1-benzazepin-1- H2 N
N
O

yl]acetate 109010-60-8 25mg O

0025 Related compound F (USP): tert-butyl (S)-2-(3-amino-2-oxo-


2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)acetate
Impurity G (EP): Ethyl (2S)-2-[[(3S)-1-(2-Ethoxy-2-oxoethyl)-
2-oxo-2,3,4,5-tetrahydro-1H-1-benzazepin-3-yl]amino]-4- O
MM1229.02- phenylbutanoate (Benazepril Ethyl Ester) H
N
N
O
O

Related compound G (USP): ((3-(1-Ethoxycarbonyl-3-


103129-58-4 25mg O O
0025
phenyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-
(3S)-benzazepine)-1-acetic acid, ethyl ester
O
H O
N
N
O
MM1229.09 Benazepril Methyl Ester n/a 100mg O O

O
H O
MM1229.10- N
N
O
Benazepril Isopropyl Ester n/a 25mg O O
0025

MM1229.11- Ethyl (2S)-2-Amino-4-phenylbutanoate Hydrochloride (L- NH2 HCl


90891-21-7 25mg
0025 Homophenylalanine Ethyl Ester Hydrochloride) O O

O
H O
N
MM1229.12- N
O
Benazepril tert-Butyl Ester 109010-61-9 100mg O O
0100

Bendamustine Hydrochloride
O
OH
N

MM0154.00 Bendamustine Hydrochloride 3543-75-7 250mg Cl


N N
HCl
Cl

5-[Bis(2-hydroxyethyl)amino]-1-methyl-1H-benzimidazole-2- N
O
O

MM0154.02 butanoic Acid Ethyl Ester 3543-74-6 100mg HO


N N

Related compound C (USP): Ethyl 4-5-[bis(2-hydroxyethyl) HO

MM0154.02- 5-[Bis(2-hydroxyethyl)amino]-1-methyl-1H-benzimidazole-2- N
O
O

butanoic Acid Ethyl Ester 3543-74-6 25mg HO


N N

0025 Related compound C (USP): Ethyl 4-5-[bis(2-hydroxyethyl) HO

1-Methyl-5-amino-1H-benzimidazole-2-butanoic Acid Ethyl N


O

MM0154.03
Ester
3543-73-5 100mg
H2 N N

MM0154.03- 1-Methyl-5-amino-1H-benzimidazole-2-butanoic Acid Ethyl N


O

3543-73-5 25mg
0025 Ester H2 N N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-60
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
O
MM0154.04- N
Ethyl 4-(1-Methyl-5-nitrobenzimidazol-2-yl)butanoate 3543-72-4 25mg O
N
+ N
0025 O

NH

MM0154.50 N'-Methyl-2,4-dinitroaniline 2044-88-4 100mg O + +O


N N
O O

NH
MM0154.50-
N'-Methyl-2,4-dinitroaniline 2044-88-4 25mg O + +O
0025 N N
O O

NH
MM0154.51-
N-Methyl-2-amino-4-nitroaniline 41939-61-1 25mg O +
0025 N NH2
O

N O
MM0154.53 Ethyl 5-(1-Methyl-5-nitro-benzimidazol-2-yl)pentanoate 3543-76-8 100mg O + N
N
O

MM0154.53- N O
Ethyl 5-(1-Methyl-5-nitro-benzimidazol-2-yl)pentanoate 3543-76-8 25mg O + N
0025 N
O

O
MM0154.54-
N O
Ethyl 5-(5-Amino-1-methylbenzimidazol-2-yl)pentanoate 3543-77-9 25mg
0025 H2 N N

O
O
MM0154.19- N
Bendamustine 1-Methylethyl Ester 1313020-25-5 25mg Cl
N N
0025 Cl

Bendroflumethiazide
O O O O
S S
H2 N NH
MM0674.00 Bendroflumethiazide 73-48-3 100mg F
N
H
F F

O O O O
S S
Impurity A (EP): 4-Amino-6-(trifluoromethyl)benzene- H 2N NH2
MM0674.01 654-62-6 100mg F
1,3-disulphonamide NH2
F F

O O O O
S S
MM0674.01- Impurity A (EP): 4-Amino-6-(trifluoromethyl)benzene- H 2N NH2
654-62-6 25mg F
0025 1,3-disulphonamide NH2
F F

Benfluorex Hydrochloride

MM1298.01- Impurity A (EP) as Hydrochloride: 2-[[(1RS)-1-Methyl- HCl


H
N
O

2-[2-(trifluoromethyl)phenyl]ethyl]amino]ethyl n/a 25mg F


O

F
0025 Benzoate Hydrochloride F

MM1298.02- Impurity B (EP) as Hydrochloride: 2-[[(1RS)-1- H


N
O

Methyl-2-[4-(trifluoromethyl)phenyl]ethyl]-
O HCl
22444-70-8 25mg F

F F
0025 amino]ethyl Benzoate Hydrochloride
O
MM0278.01-
Impurity C (EP): Benzoic Acid 65-85-0 250mg OH
0250

MM1298.05- Impurity E (EP): N-(2-Hydroxyethyl)-N-[(1RS)-1-methyl- N


OH
n/a 25mg
0025 2-[3-(trifluoromethyl)phenyl]ethyl]benzamide
F
F
F

O
O
MM1298.06- Impurity F (EP): 2-[Benzoyl[(1RS)-1-methyl-2-[3-(tri- N
O
n/a 25mg
0025 fluoromethyl)phenyl]ethyl]amino]ethyl Benzoate
F
F
F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-61
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Benorilate
O
H
N
O O

MM0399.00 Benorilate 5003-48-5 100mg O


O

Benoxaprofen
OH
MM1828.00 Benoxaprofen 51234-28-7 50mg Cl
N

O
O

MM1828.01- N O
Benoxaprofen Methyl Ester 87498-09-7 25mg Cl
O
O
0025

MM1828.02- N O

Benoxaprofen Ethyl Ester 51234-41-4 25mg Cl


O
O
0025
N O
Cl
MM1828.04- Benoxaprofen 1,3-Butylene Glycol Esters (Mixture of Regio- O OH
O

n/a 25mg N O OH
0025 and Stereoisomers) Cl
O
O

Benoxinate Hydrochloride, see Oxybuprocaine Hydrochloride

Benperidol
O
H
N
N

MM0113.00 Benperidol 2062-84-2 100mg


O
N

O
H
N
Impurity A (EP): 1-(Piperidin-4-yl)-1,3- N
MM0113.03 20662-53-7 100mg
dihydro-2H-benzimidazol-2-one
HN

O
H
N
MM0113.03- Impurity A (EP): 1-(Piperidin-4-yl)-1,3- N
20662-53-7 25mg
0025 dihydro-2H-benzimidazol-2-one
HN

O
H
N

Mixture of Impurity D and E (EP): Benperidol N-Oxide (cis O


+
N

MM0113.09 118435-01-1 25mg N


and trans) F
O

O
Cl
MM0113.07 4-Chloro-4'-fluorobutyrophenone 3874-54-2 100mg
F

Benserazide Hydrochloride
NH2
H
N OH
N
MM1282.00 Benserazide Hydrochloride 14919-77-8 250mg HO OH
H
O
HCl
OH

N H2
MM1282.01- Impurity A (EP) as Hydrochloride: (2RS)-2-Amino-3- H
N OH HCl
55819-71-1 25mg H2 N
0025 hydroxypropanohydrazide Hydrochloride O

Benzalkonium Chloride
Cl

MM0224.00 Benzalkonium Chloride 8001-54-5 500mg N


+

MM0795.00- OH
Impurity A (EP): Benzyl Alcohol 100-51-6 250mg
0250

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-62
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0528.05- O
Impurity B (EP): Benzaldehyde 100-52-7 500mg
0500

MM0224.06-
Impurity C (EP): (Chloromethyl)benzene 100-44-7 500mg
0500 Cl

Cl

MM0224.01 Benzyldimethyldodecylammonium Chloride 139-07-1 500mg N


+

Cl

MM0224.02 Benzyldimethyltetradecylammonium Chloride 139-08-2 500mg N


+

Cl

MM0224.03 Benzyldimethylhexadecylammonium Chloride 122-18-9 500mg N


+

N
MM0451.05 Dimethyldodecylamine 112-18-5 100mg

Benzbromarone
O
Br

MM0456.00 Benzbromarone 3562-84-3 500mg O


OH
Br

Impurity C (EP): (2-Ethylbenzofuran-3-yl)(4- O


MM0456.03 1477-19-6 100mg
hydroxyphenyl)methanone (Benzarone) OH

MM0456.03- Impurity C (EP): (2-Ethylbenzofuran-3-yl)(4- O


1477-19-6 25mg
0025 hydroxyphenyl)methanone (Benzarone) OH

Benzethonium Chloride
+
O N

MM1425.00 Benzethonium Chloride 121-54-0 250mg O


Cl

Benzocaine
O
MM0094.00- O
Benzocaine 94-09-7 250mg
0250 H2 N

NH2

MM0147.04 Impurity B (EP): (2-Aminophenyl)methanol 5344-90-1 100mg OH

NH2
MM0147.04-
Impurity B (EP): (2-Aminophenyl)methanol 5344-90-1 25mg OH
0025

Impurity C (EP) as Methanesulfonate: Ethyl 3- O


H 2N O O
O
MM3272.00 Aminobenzoate Methanesulfonate (Tricaine 886-86-2 250mg S
OH

Methanesulfonate)
O

MM1255.01- OH
Impurity E (EP): 4-Nitrobenzoic Acid 62-23-7 25mg O +
0025 N
O

MM0094.03 150-13-0 100mg OH


Impurity G (EP): 4-Aminobenzoic Acid
H 2N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-63
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
MM1255.07- O
Impurity H (EP): Methyl 4-Aminobenzoate 619-45-4 25mg
0025 H2 N

O O
MM0094.01-
Benzocaine Acetylsalicylamide 23437-10-7 25mg N
H
0025 O

O O
MM0094.02 N-Acetylbenzocaine 5338-44-3 100mg
N
H

MM0094.02- O O
N-Acetylbenzocaine 5338-44-3 25mg
0025 N
H

O
MM0094.04 Ethyl 4-Nitrobenzoate 99-77-4 100mg O +
N
O

MM0094.04- O
Ethyl 4-Nitrobenzoate 99-77-4 25mg O +
0025 N
O

O O
MM0094.05 Ethyl 4-Formamidobenzoate (N-Formylbenzocaine) 5422-63-9 100mg
N
H

MM0094.05- O O
Ethyl 4-Formamidobenzoate (N-Formylbenzocaine) 5422-63-9 25mg
0025 N
H

Benzoxonium Chloride
HO
OH

MM3761.00 Benzoxonium Chloride 19379-90-9 250mg N


+

5
Cl

Benzoyl Peroxide Hydrous


O
MM0278.01-
Impurity B (EP): Benzoic Acid 65-85-0 250mg OH
0250

MM0730.01 Impurity C (EP): Ethyl Benzoate 93-89-0 100mg O

Benzthiazide
O O O O
S S

MM1716.00 Benzthiazide 91-33-8 50mg H 2N

Cl N
NH
S

Benztropine Mesilate
H
O O

MM1227.00 Benztropine Mesilate 132-17-2 250mg H


O
N
S
OH

H
MM1227.02- H HCl
+
Benztropine N-Oxide Hydrochloride n/a 25mg O N
O
0025 H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-64
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Benzydamine Hydrochloride
N
N O
MM0142.00-
Benzydamine Hydrochloride 132-69-4 250mg N
HCl

0250
H
N
N O
Impurity C (EP): 1-Benzyl-1H-indazol-3-ol (1-Benzyl-1,2-
MM0142.04 2215-63-6 100mg
dihydro-3H-indazol-3-one)

H
N
N O
MM0142.04- Impurity C (EP): 1-Benzyl-1H-indazol-3-ol (1-Benzyl-1,2-
2215-63-6 25mg
0025 dihydro-3H-indazol-3-one)

Impurity G (EP) as Hydrochloride: 3-Chloro-N,N-


dimethylpropan-1-amine Hydrochloride (1-Chloropropyl Cl N HCl
MM0290.02 5407-04-5 100mg
(dimethyl)amine Hydrochloride; N,N-Dimethyl-3-
chloropropylamine Hydrochloride)
Impurity G (EP) as Hydrochloride: 3-Chloro-N,N-
MM0290.02- dimethylpropan-1-amine Hydrochloride (1-Chloropropyl Cl N HCl
5407-04-5 25mg
0025 (dimethyl)amine Hydrochloride; N,N-Dimethyl-3-
chloropropylamine Hydrochloride)

MM0142.08 Benzydamine N-Oxide Hydrochloride 39860-94-1 100mg N

+
HCl

O N
O

NH2

MM0142.06 Methyl 2-Aminobenzoate (Methyl Anthranilate) 134-20-3 100mg O

Benzyl Alcohol

MM0795.00- OH
Benzyl Alcohol 100-51-6 250mg
0250

MM0528.05- O
Impurity A (EP): Benzaldehyde 100-52-7 500mg
0500

OH
MM0795.02 Impurity B (EP): Cyclohexylmethanol 100-49-2 100mg

Benzyl Benzoate
O
MM0570.00- O
Benzyl Benzoate 120-51-4 250mg
0250

Benzyl Nicotinate
O

MM0104.00 Benzyl Nicotinate 94-44-0 500mg N O

O
MM0553.00-
Nicotinic Acid 59-67-6 250mg N OH
0250

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-65
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Benzylpenicillin Benzathine (Penicillin G Benzathine)


O
OH
H O
N

Benzylpenicillin Benzathine
N
H
N
MM0513.00 1538-09-6 500mg S
N H
H O
2

N H2
HN

MM0513.02 Impurity A (EP): Monobenzylethylendiamine 4152-09-4 100mg

O
MM0160.03 Impurity B (EP): Phenylacetic Acid 103-82-2 100mg
OH

MM0160.03- O
Impurity B (EP): Phenylacetic Acid 103-82-2 25mg
0025 OH

O
OH
Impurity C (EP): (4S)-2-[2-[Benzyl[2-(benzylamino)ethyl] HN
H
MM0513.08- amino]-2-oxo-1-(2-phenylacetamido)ethyl]-5,5-dimethyl-1,3- N
S
H
n/a 25mg O N

0025 thiazolidine-4-carboxylic Acid (Benzylpenicilloic Acids O N

Benzathide)
O
Impurity D (EP): (3S,7R,7aR)-5-Benzyl-2,2- OH

dimethyl-2,3,7,7a-tetrahydroimidazo[5,1-b]- N
N
MM0160.07 13093-87-3 100mg
thiazole-3,7-dicarboxylic Acid H
S

HO
(Penillic Acid of Benzylpenicillin) O

O
Impurity D (EP): (3S,7R,7aR)-5-Benzyl-2,2- OH

MM0160.07- dimethyl-2,3,7,7a-tetrahydroimidazo[5,1-b]- N
N
13093-87-3 25mg
0025 thiazole-3,7-dicarboxylic Acid H
S

HO
(Penillic Acid of Benzylpenicillin) O

Impurity E (EP): (4S)-2-[Carboxy[(phenylacetyl)- O


OH

amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
MM0160.01 13057-98-2 100mg N
carboxylic Acid (Penicilloic Acids of O
S

Benzylpenicillin) O OH

Impurity E (EP): (4S)-2-[Carboxy[(phenylacetyl)- O


OH

MM0160.01- amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
13057-98-2 25mg N
0025 carboxylic Acid (Penicilloic Acids of O
S

Benzylpenicillin) O OH

Impurity F (EP): (2RS,4S)-2-[[(Phenylacetyl)- O


OH

amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
MM0160.05 501-34-8 100mg N
carboxylic Acid (Penilloic Acids of O
S

Benzylpenicillin)
Impurity F (EP): (2RS,4S)-2-[[(Phenylacetyl)- O
OH

MM0160.05- amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
501-34-8 25mg N
0025 carboxylic Acid (Penilloic Acids of O
S

Benzylpenicillin)
Impurity G (EP) as Sodium Salt: (2S,5R,6R)-6-[2-(4- O
O Na
+

Hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1- O

H
N
N

MM0160.06 5985-13-7 100mg


azabicyclo[3.2.0]heptane-2-carboxylic Acid Sodium Salt (4- HO
O
H
S

Hydroxybenzylpenicillin Sodium Salt)


Impurity G (EP) as Sodium Salt: (2S,5R,6R)-6-[2-(4- O
O Na
+

MM0160.06- Hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1- O

H
N
N

5985-13-7 25mg
0025 azabicyclo[3.2.0]heptane-2-carboxylic Acid Sodium Salt (4- HO
O
H
S

Hydroxybenzylpenicillin Sodium Salt)


H
N O

MM0513.01 N,N'-Dibenzylethylenediamine Diacetate 122-75-8 100mg N


HO
2
H

H
N O
MM0513.01-
N,N'-Dibenzylethylenediamine Diacetate 122-75-8 25mg N
HO
2
0025 H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-66
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Benzylpenicillin Potassium (Penicillin G Potassium)


O +
O K
O
N
MM0160.00 Benzylpenicillin Potassium 113-98-4 250mg H
N
S
H
O

O
Impurity A (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
MM0026.04 551-16-6 100mg
heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H

O
Impurity A (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
MM0026.04- dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
551-16-6 25mg
0025 heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H

O
MM0160.03 Impurity B (EP): Phenylacetic Acid 103-82-2 100mg
OH

MM0160.03- O
Impurity B (EP): Phenylacetic Acid 103-82-2 25mg
0025 OH

Impurity C (EP) as Sodium Salt: (2S,5R,6R)-6-[[(4-


Hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo- O
N
O
O Na
+

MM0160.06 4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic 5985-13-7 100mg H


N
H
S

Acid Sodium Salt (4-Hydroxybenzylpenicillin HO


O

Sodium Salt)
Impurity C (EP) as Sodium Salt: (2S,5R,6R)-6-[[(4-
MM0160.06- Hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo- O
N
O
O Na
+

4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic 5985-13-7 25mg H


N
H
S

0025 Acid Sodium Salt (4-Hydroxybenzylpenicillin HO


O

Sodium Salt)
O
Impurity D (EP): (3S,7R,7aR)-5-Benzyl-2,2- OH

dimethyl-2,3,7,7a-tetrahydroimidazo[5,1-b]- N
N
MM0160.07 13093-87-3 100mg
thiazole-3,7-dicarboxylic Acid H
S

HO
(Penillic Acid of Benzylpenicillin) O

O
Impurity D (EP): (3S,7R,7aR)-5-Benzyl-2,2- OH

MM0160.07- dimethyl-2,3,7,7a-tetrahydroimidazo[5,1-b]- N
N
13093-87-3 25mg
0025 thiazole-3,7-dicarboxylic Acid H
S

HO
(Penillic Acid of Benzylpenicillin) O

Impurity E (EP): (4S)-2-[Carboxy[(phenyl- O


OH

acetyl)amino]methyl]-5,5-dimethyl- H
HN
MM0160.01 13057-98-2 100mg N
thiazolidine-4-carboxylic Acid (Penicilloic O
S

Acids of Benzylpenicillin) O OH

Impurity E (EP): (4S)-2-[Carboxy[(phenyl- O


OH

MM0160.01- acetyl)amino]methyl]-5,5-dimethyl- H
HN
13057-98-2 25mg N
0025 thiazolidine-4-carboxylic Acid (Penicilloic O
S

Acids of Benzylpenicillin) O OH

Impurity F (EP): (2RS,4S)-2-[[(Phenylacetyl)- O


OH

amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
MM0160.05 501-34-8 100mg N
carboxylic Acid (Penilloic Acids of O
S

Benzylpenicillin)
Impurity F (EP): (2RS,4S)-2-[[(Phenylacetyl)- O
OH

MM0160.05- amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
501-34-8 25mg N
0025 carboxylic Acid (Penilloic Acids of O
S

Benzylpenicillin)

Benzylpenicillin Procaine Monohydrate (Penicillin G Procaine)


O O O
H2O OH
O

MM0302.00 Benzylpenicillin Procaine 6130-64-9 250mg N H


N
N

H
S

N H2 O

MM0094.03 Impurity A (EP): 4-Aminobenzoic Acid 150-13-0 100mg OH

H 2N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-67
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity B (EP): (4S)-2-[Carboxy[(phenyl- O


OH

acetyl)amino]methyl]-5,5-dimethyl- H
HN
MM0160.01 13057-98-2 100mg N
thiazolidine-4-carboxylic Acid O
S

(Penicilloic Acids of Benzylpenicillin) O OH

Impurity B (EP): (4S)-2-[Carboxy[(phenyl- O


OH

MM0160.01- acetyl)amino]methyl]-5,5-dimethyl- H
HN
13057-98-2 25mg N
0025 thiazolidine-4-carboxylic Acid O
S

(Penicilloic Acids of Benzylpenicillin) O OH

Impurity C (EP): (2RS,4S)-2-[[(Phenylacetyl)- O


OH

amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
MM0160.05 501-34-8 100mg N
carboxylic Acid (Penilloic Acids of O
S

Benzylpenicillin)
Impurity C (EP): (2RS,4S)-2-[[(Phenylacetyl)- O
OH

MM0160.05- amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
501-34-8 25mg N
0025 carboxylic Acid (Penilloic Acids of O
S

Benzylpenicillin)
O
Impurity D (EP): (3S,7R,7aR)-5-Benzyl-2,2- OH

dimethyl-2,3,7,7a-tetrahydroimidazo[5,1- N
N
MM0160.07 13093-87-3 100mg
b]thiazole-3,7-dicarboxylic Acid (Penillic H
S

HO
Acid of Benzylpenicillin) O

O
Impurity D (EP): (3S,7R,7aR)-5-Benzyl-2,2- OH

MM0160.07- dimethyl-2,3,7,7a-tetrahydroimidazo[5,1- N
N
13093-87-3 25mg
0025 b]thiazole-3,7-dicarboxylic Acid (Penillic H
S

HO
Acid of Benzylpenicillin) O

O
MM0160.03 Impurity E (EP): Phenylacetic Acid 103-82-2 100mg
OH

MM0160.03- O
Impurity E (EP): Phenylacetic Acid 103-82-2 25mg
0025 OH

Impurity F (EP) as Sodium Salt: (2S,5R,6R)-6-[2-(4- O +


O Na
O
Hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1- H
N

MM0160.06 5985-13-7 100mg N


S
H
azabicyclo[3.2.0]heptane-2-carboxylic Acid (4- O
HO

Hydroxybenzylpenicillin Sodium Salt)


Impurity F (EP) as Sodium Salt: (2S,5R,6R)-6-[2-(4- O +
O Na
O
MM0160.06- Hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1- H
N

5985-13-7 25mg N
S
H
0025 azabicyclo[3.2.0]heptane-2-carboxylic Acid (4- HO
O

Hydroxybenzylpenicillin Sodium Salt)

Bephenium Embonate
+ O
N

MM1833.00 Bephenium Embonate 21847-63-2 50mg O OH HO O

O O

Bephenium Hydroxynaphthoate
+ O
N

MM1832.00 Bephenium Hydroxynaphthoate 3818-50-6 100mg O

OH

Berberine Chloride
O
O

MM1632.00 Berberine Chloride 633-65-8 250mg N


+

O
O Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-68
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Berberine Hemisulfate
O
O

O O

MM3304.00 Berberine Hemisulfate 316-41-6 250mg O


N
+
O
S
O

O
2

Beta Alanine
MM3497.04- O
HCl
Beta Alanine Isopropyl Ester Hydrochloride 51871-17-1 25mg H 2N O
0025

Betahistine Dihydrochloride
H
MM0587.00- N N
Betahistine Dihydrochloride 5579-84-0 250mg HCl
0250 2

N
MM0587.01 Impurity A (EP): 2-Ethenylpyridine (2-Vinylpyridine) 100-69-6 100mg

N OH
Impurity B (EP): 2-(Pyridin-2-yl)ethanol
MM0587.02 103-74-2 100mg
(2-(2-Hydroxyethyl)pyridine)

Impurity C (EP) as Trihydrochloride: N-Methyl-2-


N N N

MM0587.03 (pyridin-2-yl)-N-[2-(pyridin-2-yl)ethyl]ethanamine 2095467-43-7 100mg HCl


3

Trihydrochloride

MM0587.03- Impurity C (EP) as Trihydrochloride: N-Methyl-2-


N N N

(pyridin-2-yl)-N-[2-(pyridin-2-yl)ethyl]ethanamine 2095467-43-7 25mg HCl


3

0025 Trihydrochloride
Impurity C (EP) as Trimesilate: N-Methyl-2-(pyridin-
N N N O O

MM0587.04 2-yl)-N-[2-(pyridin-2-yl)ethyl]ethanamine n/a 100mg S


OH
3

Trimesilate

MM0587.04- Impurity C (EP) as Trimesilate: N-Methyl-2-(pyridin-


N N N O O

2-yl)-N-[2-(pyridin-2-yl)ethyl]ethanamine n/a 25mg S


OH
3

0025 Trimesilate

Betahistine Mesilate
H
N N
O O
MM0367.00 Betahistine Mesilate 54856-23-4 250mg S
OH
2

Betaine
O
MM3894.00- +
Betaine 107-43-7 1g N
1000 O

Betaine Hydrochloride
Cl
O
MM0611.00 Betaine Hydrochloride 590-46-5 500mg +
N
OH

MM0611.01- O
+
Betaine Methyl Ester Chloride 3032-10-8 25mg N Cl
O
0025

MM0611.02- O
+
Betaine Ethyl Ester Chloride 3032-11-9 25mg N Cl
O
0025

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-69
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0611.03- O
+
Betaine Isopropyl Ester Chloride 110675-64-4 25mg N Cl
O
0025
O
MM3894.00- +
Betaine 107-43-7 1g N
1000 O

Betamethasone
O
OH
HO OH

MM0200.00 Betamethasone 378-44-9 250mg H

F H
O

O
OH
HO OH

MM0213.00 Impurity A (EP): Dexamethasone 50-02-2 250mg H

F H
O

Impurity B (EP): 21-Chloro-9-fluoro-11 ,17- HO OH


Cl

MM0200.01 dihydroxy-16 -methylpregna-1,4-diene- 25122-41-2 100mg H

F H
3,20-dione (Clobetasol) O

O
OH
Impurity E (EP): 9,11 -Epoxy-17,21-dihydroxy-16 -methyl- O
OH

MM0200.04 981-34-0 100mg


9 -pregna-1,4-diene-3,20-dione H H
O

O
OH
MM0200.04- Impurity E (EP): 9,11 -Epoxy-17,21-dihydroxy-16 -methyl- O
OH

981-34-0 25mg
0025 9 -pregna-1,4-diene-3,20-dione H H
O

OH
HO
MM0200.11- 9-Fluoro-11 ,21-dihydroxy-16-methylpregna-1,4,16-triene- H
59860-99-0 25mg
0025 3,20-dione F H
O

O OH
MM0213.13- OH
H
17,21-Dihydroxy-16 -methylpregna-1,4-diene-3,11,20-trione 2036-77-3 25mg
0025 H H
O

O
HO
Betamethasone-17-ketone (9a-Fluoro-11ß-hydroxy-16ß- H
MM0200.13 3109-01-1 100mg
methylandrosta-1,4-diene-3,17-dione) F H
O

O
HO
MM0200.13- Betamethasone-17-ketone (9a-Fluoro-11ß-hydroxy-16ß- H
3109-01-1 25mg
0025 methylandrosta-1,4-diene-3,17-dione) F H
O

Betamethasone Acetate
O
O
O
HO OH
MM0201.00 Betamethasone Acetate 987-24-6 250mg H

F H
O

O
OH
HO OH

MM0200.00 Impurity A (EP): Betamethasone 378-44-9 250mg H

F H
O

O
O
O
HO OH
MM0445.00 Impurity B (EP): Dexamethasone Acetate 1177-87-3 250mg H

F H
O

Impurity C (EP): Betamethasone 11,21-Diacetate O O


O

Related compound C (USP): 9-Fluoro-11Beta,17,21- O


H
OH
O

MM0201.03 330157-05-6 100mg


trihydroxy-16Beta-methylpregna-1,4-diene-3,20-dione 11,21- F H

diacetate O

Impurity C (EP): Betamethasone 11,21-Diacetate O O


O

MM0201.03- Related compound C (USP): 9-Fluoro-11Beta,17,21- O


H
OH
O

330157-05-6 25mg
0025 trihydroxy-16Beta-methylpregna-1,4-diene-3,20-dione 11,21- F H

diacetate O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-70
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Betamethasone Dipropionate
O

O
O O

MM0202.00 Betamethasone Dipropionate 5593-20-4 250mg HO


H
O

F H
O

O
OH
HO OH
Impurity A (EP): 9-Fluoro-11 ,17,21-trihydroxy-16 - H
MM0200.00 378-44-9 250mg
methylpregna-1,4-diene-3,20-dione (Betamethasone) F H
O

Impurity C (EP): 9-Fluoro-11 ,17-dihydroxy-16 -methyl-3,20-


O

dioxopregna-1,4-dien-21-yl Propanoate (Betamethasone 21- O


O

HO OH
MM0202.04 Propionate) 75883-07-7 100mg H

F H
Related compound C (USP): 9-Fluoro-11Beta,17-dihydroxy- O

16Beta-methyl-3,20-dioxopregna-1,4-diene-21-yl propionate
Impurity C (EP): 9-Fluoro-11 ,17-dihydroxy-16 -methyl-3,20-
O

dioxopregna-1,4-dien-21-yl Propanoate (Betamethasone 21- O


O
MM0202.04- HO OH
Propionate) 75883-07-7 25mg H
0025 F H
Related compound C (USP): 9-Fluoro-11Beta,17-dihydroxy- O

16Beta-methyl-3,20-dioxopregna-1,4-diene-21-yl propionate
O

Impurity E (EP): 9-Chloro-11 -hydroxy-16 -methyl-3,20- O


O O

HO O
MM0199.00 dioxopregna-1,4-diene-17,21-diyl Dipropanoate 5534-09-8 250mg H

Cl H
(Beclometasone Dipropionate) O

OH
HO
MM0200.11- 9-Fluoro-11 ,21-dihydroxy-16-methylpregna-1,4,16-triene- H
59860-99-0 25mg
0025 3,20-dione F H
O

Betamethasone Sodium Phosphate


+
O O O Na
P +
O O Na
HO OH

MM0303.00 Betamethasone Sodium Phosphate 151-73-5 250mg H

F H
O

Betamethasone Valerate
OH
O O

HO O

MM0203.00 Betamethasone 17-Valerate 2152-44-5 250mg H

F H
O

O
OH
HO OH

MM0200.00 Impurity A (EP): Betamethasone 378-44-9 250mg H

F H
O

Impurity E (EP): 9-Fluoro-11 ,17-dihydroxy-16 -methyl- O

3,20-dioxopregna-1,4-dien-21-yl Pentanoate O
O

MM0203.01 (Betamethasone 21-Valerate) 2240-28-0 100mg HO


H
OH

Related compound A (USP): 9-Fluoro-11beta,17-dihydroxy- O


F H

16beta-methyl-3,20-dioxopregna-1,4-diene-21-yl valerate
Impurity E (EP): 9-Fluoro-11 ,17-dihydroxy-16 -methyl- O

MM0203.01- 3,20-dioxopregna-1,4-dien-21-yl Pentanoate O


O

(Betamethasone 21-Valerate) 2240-28-0 25mg HO


H
OH

0025 Related compound A (USP): 9-Fluoro-11beta,17-dihydroxy- O


F H

16beta-methyl-3,20-dioxopregna-1,4-diene-21-yl valerate

Betaxolol Hydrochloride
OH
H
O N

MM0436.00 Betaxolol Hydrochloride 63659-19-8 250mg O HCl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-71
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP) as Hydrochloride: (2RS)-1-(4-


MM0436.01- Ethylphenoxy)-3-[(1-methylethyl)amino]- OH
H
O N
propan-2-ol Hydrochloride 464877-45-0 25mg HCl

0025 Related compound A (USP): 1-(4-Ethylphenoxy)-3-


(isopropylamino)propan-2-ol
OH
Impurity B (EP): (2RS)-1-[4-(2-Hydroxyethyl)- O
H
N
MM0027.10 62572-94-5 100mg
phenoxy]-3-[(1-methylethyl)amino]propan-2-ol HO

Impurity B (EP): (2RS)-1-[4-(2-Hydroxyethyl)-


OH
H
MM0027.10- O N
62572-94-5 25mg
0025 phenoxy]-3-[(1-methylethyl)amino]propan-2-ol HO

Impurity C (EP): 2-[[4-[2-(Cyclopropylmethoxy)- O


O

MM0436.03 63659-17-6 50mg


ethyl]phenoxy]methyl]oxirane O

OH
Impurity D (EP): 4-[2-(Cyclopropylmethoxy)ethyl]-
MM0436.04 63659-16-5 50mg
phenol O

MM0436.05- Impurity E (EP) as Hydrochloride: (2RS)-1-[4-(2- HCl


OH
H
O N

Butoxyethyl)phenoxy]-3-[(1-methylethyl)amino]- n/a 25mg O


0025 propan-2-ol Hydrochloride
MM0436.06- 1-[4-(2-Cyclobutoxyethyl)phenoxy]-3-(isopropyl- HCl
O
OH
H
N

n/a 25mg
0025 amino)propan-2-ol Hydrochloride O

Bethanechol Chloride
O

MM1634.00 Bethanechol Chloride 590-63-6 250mg H2 N O


+
Cl
N

Bezafibrate
O
O
O OH

MM0063.00 Bezafibrate 41859-67-0 500mg N


H
Cl

Impurity A (EP): 4-Chloro-N-[2-(4- O


OH

MM0063.01 hydroxyphenyl)ethyl]benzamide 41859-57-8 100mg N


H

(4-Chlorobenzoyltyramine) Cl

MM0063.01- Impurity A (EP): 4-Chloro-N-[2-(4- O


OH

hydroxyphenyl)ethyl]benzamide 41859-57-8 25mg N


H
0025 (4-Chlorobenzoyltyramine) Cl

MM0063.03 Impurity B (EP): 4-Chlorobenzoic Acid 74-11-3 100mg OH

Cl

O
MM0063.03-
Impurity B (EP): 4-Chlorobenzoic Acid 74-11-3 25mg OH
0025
Cl

Impurity C (EP): Methyl 2-[4-[2-[(4-Chloro- O


O
O

MM0063.04 benzoyl)amino]ethyl]phenoxy]-2- n/a 100mg N


H

methylpropanoate Cl

MM0063.04- Impurity C (EP): Methyl 2-[4-[2-[(4-Chloro- O


O
O

benzoyl)amino]ethyl]phenoxy]-2- n/a 25mg N


H
0025 methylpropanoate Cl

Impurity D (EP): Ethyl 2-[4-[2-[(4-Chloro- O


O
O

MM0063.02 benzoyl)amino]ethyl]phenoxy]-2- 41859-58-9 100mg N


H

methylpropanoate
Cl

MM0063.02- Impurity D (EP): Ethyl 2-[4-[2-[(4-Chloro- O


O
O

benzoyl)amino]ethyl]phenoxy]-2- 41859-58-9 25mg N


H

methylpropanoate
0025 Cl

Impurity E (EP): Butyl 2-[4-[2-[(4-Chloro- O


O

O O

MM0063.05 benzoyl)amino]ethyl]phenoxy]-2- n/a 100mg N


H
Cl

methylpropanoate

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-72
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0063.05- Impurity E (EP): Butyl 2-[4-[2-[(4-Chloro- O


O

O O

benzoyl)amino]ethyl]phenoxy]-2- n/a 25mg N


H
Cl
0025 methylpropanoate
NH2

MM0063.06 Tyramine 51-67-2 100mg


HO

NH2
MM0063.06-
Tyramine 51-67-2 25mg
0025 HO

Cl

N,O-Bis-(4-chlorobenzoyl)tyramine
O
O
MM0063.07 41859-56-7 100mg N
H
Cl

Cl

MM0063.07- O

N,O-Bis-(4-chlorobenzoyl)tyramine
O
O
41859-56-7 25mg N
H
0025 Cl

O
O
O O

MM0063.08 Bezafibrate Isopropyl Ester 153758-85-1 100mg N


H
Cl

O
O
MM0063.08- O O

Bezafibrate Isopropyl Ester 153758-85-1 25mg N


H
0025 Cl

Bibenzonium Bromide
O +
N

MM1835.00 Bibenzonium Bromide 15585-70-3 100mg Br

Bicalutamide
O OH O F F
H
MM0894.00- S N

Bicalutamide 90357-06-5 250mg F


O
F

0250 N

O OH O F F
H
MM0894.25- S N
F
(R)-Bicalutamide 113299-40-4 25mg O
F
0025 N

O OH O F F
H
MM0894.26- S N
F
(S)-Bicalutamide 113299-38-0 25mg F
O

0025 N

O OH O F F
MM0894.02- Impurity A (EP): (2RS)-N-[4-Cyano-3-(trifluoromethyl) S
H
N
F
90357-05-4 25mg O
0025 phenyl]-2-hydroxy-2-methyl-3-(phenylsulfonyl)propanamide N

MM0894.03- Impurity B (EP): (2RS)-N-[4-Cyano-3-(trifluoromethyl) O


S
OH O
H
N
F F

F
phenyl]-3-[(2-fluorophenyl)sulfonyl]-2-hydroxy-2- 1159977-36-2 25mg F
O
N
0025 methylpropanamide

MM0894.04- Impurity C (EP): (2RS)-N-[4-Cyano-3-(trifluoromethyl) O O


S
H
N
F F

phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-methylpropanamide 906008-94-4 25mg F


O
F

N
0025 (Dehydroxybicalutamide)
F F
H2 N
F
MM0894.05 Impurity D (EP): 4-Amino-2-(trifluoromethyl)benzonitrile 654-70-6 100mg
N

F F
H2 N
MM0894.05- F
Impurity D (EP): 4-Amino-2-(trifluoromethyl)benzonitrile 654-70-6 25mg
0025
N

MM0894.06- Impurity E (EP): (2RS)-N-[4-Cyano-3-(trifluoromethyl) OHO


AND Enantiomer
F F
H

phenyl]-3-[(RS)-(4-fluorophenyl)sulfinyl]-2-hydroxy-2- n/a 25mg F


S

O
N
F

N
0025 methylpropanamide
HO F F
Impurity J (EP): (2RS)-N-[4-Cyano-3-(trifluoromethyl)phenyl]- S
H
N
F
MM0894.12 90356-78-8 100mg O
3-[(4-fluorophenyl)sulfanyl]-2-hydroxy-2-methylpropanamide F
N

HO F F
MM0894.12- Impurity J (EP): (2RS)-N-[4-Cyano-3-(trifluoromethyl)phenyl]- S
H
N
F
90356-78-8 25mg O

0025 3-[(4-fluorophenyl)sulfanyl]-2-hydroxy-2-methylpropanamide F
N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-73
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O HO O
MM0894.15- Impurity M (EP): (2RS)-3-[(4-Fluorophenyl)sulfonyl]-2- HO S
151262-57-6 25mg
0025 hydroxy-2-methylpropanoic Acid O
F

N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-
fluorophenyl)sulfinyl]-2-hydroxy-2-methyl- O HO F F
MM0894.01- propanamide S
H
N
F

Related compound A (USP): N-[4-cyano-3-(trifluoromethyl)


945419-64-7 25mg F
O

0025 N

phenyl]-3-[(4-fluoro-phenyl)sulfinyl]-2-hydroxy-2-methyl-
propanamide
(RS)-N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-(3-
fluorophenylsulfonyl)-2-hydroxy-2-methylpropanamide O OH O
H
F F
MM0894.08- F S N
F
Related compound B (USP): (RS)-N-[4-cyano-3- 1166228-30-3 25mg O

0025 N

(trifluoromethyl)phenyl]-3-(3-fluorophenylsulfonyl)-2-hydroxy-
2-methylpropanamide

MM0894.10- (2RS)-N-[4-Bromo-3- O OH O
H
F F
S N

(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)- n/a 25mg F


O
Br
F

0025 sulfonyl]-2-hydroxy-2-methylpropanamide
O F F
H
N
N-[4-Cyano-3-(trifluoromethyl)phenyl]-2-methyl-oxirane-2- F
MM0894.11 90357-51-0 100mg O
carboxamide N

O F F
H
N
MM0894.11- N-[4-Cyano-3-(trifluoromethyl)phenyl]-2-methyl-oxirane-2- F
90357-51-0 25mg O
0025 carboxamide N

O O OH
MM0894.16- Methyl 3-(4-Fluorophenyl)sulfonyl-2-hydroxy-2- S O
512776-93-1 25mg O
0025 methylpropanoate F

SH
MM0894.17-
4-Fluorothiophenol 371-42-6 100mg
0100 F

F F
H
MM0894.18- N
N-[4-Cyano-3-(trifluoromethyl)phenyl]-2-methylprop-2- F
90357-53-2 25mg O
0025 enamide N

O O
MM0894.19- S
4-Fluorobenzenesulfonic Acid 368-88-7 100mg OH
0100
F

F
F F

MM0894.20- H2 N
4-Amino-3-(trifluoromethyl)benzonitrile 327-74-2 25mg
0025
N

F
F
O F
H
MM0894.21- N-[4-Cyano-2-(trifluoromethyl)phenyl]-2-methyloxirane-2- N
1375105-27-3 25mg
0025 carboxamide O
N

MM0894.22- O O O F F
H
S N
O-Acetylbicalutamide 1375105-24-0 25mg F
O
0025 F
N

OH F F
H
MM0894.31- N-[4-Cyano-3-(trifluoromethyl)phenyl]-2,3-dihydroxy-2- HO N
F
316373-92-9 25mg O
0025 methylpropanamide N

OH F F
H
MM0894.32- 3-Chloro-N-[4-cyano-3-(trifluoromethyl)phenyl]-2-hydroxy-2- Cl N
F
627484-44-0 25mg O
0025 methylpropanamide N

Bictegravir Sodium
H O O
MM3948.00- O F F

Bictegravir Sodium 1807988-02-8 250mg H


O
N

H
N
H
N
Na
+

0250 O F

F F
MM3948.03- H2 N
2,4,6-Trifluorobenzylamine 214759-21-4 100mg
0100
F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-74
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Bifonazole

MM0318.00 Bifonazole 60628-96-8 500mg N

Impurity A (EP): (RS)-(Biphenyl-4-yl)-


MM0318.01 7598-80-3 100mg
phenylmethanol OH

MM0318.01- Impurity A (EP): (RS)-(Biphenyl-4-yl)-


7598-80-3 25mg
0025 phenylmethanol OH

H
N
MM0015.02 Impurity C (EP): 1H-Imidazole (Imidazole) 288-32-4 100mg
N

Impurity D (EP) as Chloride: 1,3-Bis[(biphenyl- N


+

Cl
MM0318.03 66600-13-3 100mg
4-yl)phenylmethyl]-1H-imidazolium Chloride N

MM0318.03- Impurity D (EP) as Chloride: 1,3-Bis[(biphenyl- N


+

Cl
66600-13-3 25mg
0025 4-yl)phenylmethyl]-1H-imidazolium Chloride N

Bilastine
OH
O
MM3614.00- O

Bilastine 202189-78-4 250mg N


N

0250 N

MM3614.01- 1-(2-Ethoxyethyl)-2-(4-piperidinyl)-1H-benzimidazole NH
HCl
n/a 25mg N
0025 Hydrochloride N

Bimatoprost
O

N
H
HO

MM3603.00 Bimatoprost 155206-00-1 100mg


HO
HO

O
H
MM3603.01- [(3aR,4R,5R,6aS)-4-Formyl-2-oxo-3,3a,4,5,6,6a- H
38754-71-1 25mg O
0025 hexahydrocyclopenta[b]furan-5-yl] 4-Phenylbenzoate O

O
[(3aR,4R,5R,6aS)-4-[(E,3S)-3-Hydroxy-5-phenylpent-1-enyl]- O
MM3316.05- H H

2-oxo-3,3a,4,5,6,6a-hexahydrocyclopenta[b]furan-5-yl] 4- 41639-73-0 25mg O


OH

0025 O
Phenylbenzoate

Biperiden Hydrochloride
AND Enantiomer

OH
MM0288.00 Biperiden Hydrochloride 1235-82-1 250mg H H
N HCl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-75
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

AND Enantiomer

OH O
H H
+
MM0288.07 Biperiden N-Oxide n/a 100mg N

AND Enantiomer

MM0288.08- H H
OH O
+
Biperiden Epoxide N-Oxide n/a 25mg N

0025 O
H

Bisacodyl
O O

O O

MM0031.00 Bisacodyl 603-50-9 500mg N

Impurity A (EP): 4,4'-(Pyridin-2-ylmethylene)- HO OH

diphenol
MM0031.01
Related compound A (USP): 4,4'-(Pyridin-2-ylmethylene)
603-41-8 100mg N

diphenol
Impurity A (EP): 4,4'-(Pyridin-2-ylmethylene)- HO OH

MM0031.01- diphenol
Related compound A (USP): 4,4'-(Pyridin-2-ylmethylene)
603-41-8 25mg N
0025
diphenol
OH
Impurity B (EP): 2-[(RS)-(4-Hydroxyphenyl)-
MM0031.04- (pyridin-2-yl)methyl]phenol
Related compound B (USP): 2,4'-(Pyridin-2-ylmethylene)
16985-05-0 25mg OH
0025 N

diphenol
Impurity C (EP): 4-[(RS)-(4-Hydroxyphenyl)- HO O

(pyridin-2-yl)methyl]phenyl Acetate O

MM0031.02
Related compound C (USP): 4-[(4-Hydroxyphenyl)(pyridin-
72901-16-7 100mg N

2-yl)methyl]phenyl acetate
Impurity C (EP): 4-[(RS)-(4-Hydroxyphenyl)- HO O

MM0031.02- (pyridin-2-yl)methyl]phenyl Acetate O

Related compound C (USP): 4-[(4-Hydroxyphenyl)(pyridin-


72901-16-7 25mg N
0025
2-yl)methyl]phenyl acetate
O

Impurity E (EP): 2-[(RS)-[4-(Acetyloxy)phenyl]- O O

(pyridin-2-yl)methyl]phenyl Acetate O
MM0031.03
Related compound E (USP): 2-[(4-Acetoxyphenyl)(pyridin-2-
111664-35-8 50mg
N
yl)methyl]phenyl acetate

4-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl)- HO O
S
O Na
+

methyl]phenyl Sodium Sulphate O O

MM0054.01
(4-[(Pyridin-2-yl)(4-hydroxyphenyl)methyl]-
32500-19-9 100mg N

phenyl Sodium Sulphate)


4-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl)- HO O
S
O Na
+

MM0054.01- methyl]phenyl Sodium Sulphate O O

(4-[(Pyridin-2-yl)(4-hydroxyphenyl)methyl]-
32500-19-9 25mg N
0025
phenyl Sodium Sulphate)
2-[(RS)-(Pyridin-2-yl)[4-(sulphonatooxy)- Na
+O
S
O

MM0054.02- phenyl]methyl]phenyl Disodium Sulphate O O


Na
+

n/a 25mg
0025 (2,4'-[(Pyridin-2-yl)methylene]bisphenyl N
O

O O
S
O

Bis(Sodium Sulphate))

Bis(2-ethylhexyl) Maleate

MM2104.00 Bis(2-ethylhexyl) Maleate 142-16-5 250mg O


O O
O

Bisoctrizole
N OH OH N
N N
N N
MM3255.00-
Bisoctrizole 103597-45-1 250mg
0250

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-76
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HO
N
2-(2H-Benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol N
N
MM3255.01 Related compound A (USP): 2-(2H-Benzotriazol-2-yl)-4- 3147-75-9 100mg
(1,1,3,3-tetramethylbutyl) phenol
HO
N
2-(2H-Benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol N
MM3255.01- N
Related compound A (USP): 2-(2H-Benzotriazol-2-yl)-4- 3147-75-9 25mg
0025
(1,1,3,3-tetramethylbutyl) phenol

Bisoprolol Fumarate
OH
H
O N

MM0460.00 Bisoprolol 66722-44-9 100mg


O
O

OH OH
H
O N O
MM0460.08-
Bisoprolol Fumarate 104344-23-2 250mg O
O
0250 O HO
2

OH
H
Impurity A (EP): (RS)-1-(4-Hydroxymethyl- O N

MM0460.01 62572-93-4 100mg


phenoxy)-3-isopropylaminopropan-2-ol OH

OH
H
MM0460.01- Impurity A (EP): (RS)-1-(4-Hydroxymethyl- O N

62572-93-4 25mg
0025 phenoxy)-3-isopropylaminopropan-2-ol OH

OH
H
O N
Impurity B (EP): (RS)-1-Isopropylamino-3-[4-(2-
MM0460.07 1447715-44-7 100mg
propoxyethoxymethyl)phenoxy]propan-2-ol O
O

Impurity C (EP): (RS)-1-[4-[4-(2-Hydroxy- H


OH OH
H

3-isopropylaminopropoxy)benzyl]-
N O O N

MM0460.15 1225195-70-9 100mg


phenoxy]-3-isopropylaminopropan-2-ol

MM0460.15- Impurity C (EP): (RS)-1-[4-[4-(2-Hydroxy- H


OH OH
H

3-isopropylaminopropoxy)benzyl]-
N O O N

1225195-70-9 25mg
0025 phenoxy]-3-isopropylaminopropan-2-ol

MM0460.11- Impurity D (EP): (RS)-1-[4-[4-(2-Hydroxy-3- H


OH OH
H

isopropylaminopropoxy)benzyloxymethyl]phenoxy]-3-
N O O N

1225195-71-0 25mg O

0025 isopropylaminopropan-2-ol
O
H
Impurity E (EP): EZ-[3-[4-(2-Isopropoxyethoxy- N

MM0460.19 1217245-60-7 100mg


methyl)phenoxy]allyl]isopropylamine O
O

Impurity G (EP): (2RS)-1-[4-[[(2-Isopropoxy-


OH
ethoxy)methoxy]methyl]phenoxy]-3-iso- O
H
N

MM0460.21 propylaminopropan-2-ol 1215342-36-1 100mg


Related compound D (USP): 1-(4-[(2-Isopropoxyethoxy) O O
O

methoxy]methylphenoxy)-3-(isopropylamino)propan-2-ol
OH

MM0460.22- Impurity H (Pharmeuropa): 2-Hydroxyethyl 4-[((2RS)- HO


O
H
N

1346601-19-1 25mg O

0025 2-Hydroxy-3-(isopropylamino)propyl)oxy]benzoate O

MM0460.23- (2RS)-1-[4-((2-Hydroxy-ethoxy)methyl)phenoxy]- HO
O
OH
H
N
109791-18-6 25mg
0025 3-(isopropylamino)-2-propanol O

Impurity J (Pharmeuropa): (2RS)-3-[4-((2-Isopropoxy- O


O
OH
OH
MM0460.24 n/a 100mg
ethoxy)methyl)phenoxy]-1,2-propanediol O

Impurity K (EP): 2-Isopropoxyethyl 4-[[(2RS)-2- O


OH
H
N

MM0460.18 Hydroxy-3-(isopropylamino)propyl]oxy]- 864544-37-6 100mg O


O

benzoate (Bisoprolol Ester)

MM0460.18- Impurity K (EP): 2-Isopropoxyethyl 4-[[(2RS)-2- O


OH
H
N

Hydroxy-3-(isopropylamino)propyl]oxy]- 864544-37-6 25mg O


O

O
0025 benzoate (Bisoprolol Ester)
Impurity L (EP) as Hydrochloride: 4-[[(2RS)-2--
HCl OH
(isopropylamino)propyl]oxy]benz-Hydrochloride (4-[(2RS)-2- O
H
N
MM0027.24 1956321-87-1 100mg
Hydroxy- O

-[(1-methylethyl)amino]propoxy]benzaldehyde)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-77
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity L (EP) as Hydrochloride: 4-[[(2RS)-2--


HCl OH
MM0027.24- (isopropylamino)propyl]oxy]benz-Hydrochloride (4-[(2RS)-2- O
H
N
1956321-87-1 25mg
0025 Hydroxy- O

-[(1-methylethyl)amino]propoxy]benzaldehyde)
Impurity M (Pharmeuropa): 4-[(2-Isopropoxy- O
OH
MM0460.02 177034-57-0 100mg
ethoxy)methyl]phenol O

Impurity N (EP): [(2RS)-1-[4-[(2-Ethoxyethoxy)- O


O
OH
H
N

MM0460.25 n/a 100mg


methyl]phenoxy]-3-isopropylaminopropan-2-ol O

MM0460.25- Impurity N (EP): [(2RS)-1-[4-[(2-Ethoxyethoxy)- O


O
OH
H
N

n/a 25mg
0025 methyl]phenoxy]-3-isopropylaminopropan-2-ol O

OH
H
(2RS)-4-[2-Hydroxy-3-(isopropylamino)propoxy]- O N

MM0460.27 HO
benzoic Acid Hydrochloride
33948-04-8 50mg
O HCl

Impurity Q (EP): (2RS)-1-(Isopropylamino)-3-[4-(2- O


O
OH
H
N

MM0460.05 n/a 100mg


methoxyethoxy)methylphenoxy]propan-2-ol O

MM0460.05- Impurity Q (EP): (2RS)-1-(Isopropylamino)-3-[4-(2- O


O
OH
H
N
n/a 25mg
0025 methoxyethoxy)methylphenoxy]propan-2-ol O

OH
MM0460.28- Impurity R (EP): (2RS)-1-(Isopropylamino)-3-(4- O
H
N
5790-46-5 25mg
0025 methylphenoxy)propan-2-ol
OH

MM0460.14 Impurity S (EP): 4-Hydroxybenzaldehyde 123-08-0 100mg


O

OH

MM0460.14-
Impurity S (EP): 4-Hydroxybenzaldehyde 123-08-0 25mg
0025
O
O

Impurity T (EP): 4-[(3-Isopropyl-2-oxo-1,3-oxazolidin-5- O


N
MM0460.17- O
yl)methoxy]benzaldehyde (Bisoprolol Oxazolidinone- 1173203-26-3 25mg
0025 benzaldehyde) O

MM0460.16- Impurity U (EP): 5-[[4-(Hydroxymethyl)phenoxy]- O


O

methyl]-3-isopropyl-1,3-oxazolidin-2-one 1071765-44-0 25mg O


N

0025 (Bisoprolol Oxazolidinonebenzylalcohol) HO

O
O

2-[4-(2-Isopropoxyethoxymethyl)-
phenoxymethyl]oxirane
MM0460.03 66722-57-4 100mg
O
O

OH

MM0460.06 4-Hydroxybenzyl Alcohol 623-05-2 100mg HO

OH
MM0460.06-
4-Hydroxybenzyl Alcohol 623-05-2 25mg HO
0025
O
MM0460.10- HO
Fumaric Acid 110-17-8 250mg OH
0250 O

HO

O
MM0460.13- N
iso-Bisoprolol n/a 25mg H

0025
O
O

OH
H
O N
MM0460.29- Isopropyl 4-(2-Hydroxy-3-isopropylpropoxy)- O

benzoate Hydrochloride
n/a 25mg
O
0025 HCl

O
OH
O N

MM0460.30 N-Formylbisoprolol 1447715-45-8 100mg


O
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-78
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
OH
O N

MM0460.31 N-Acetylbisoprolol 66722-65-4 100mg


O
O

O
O
O
MM0460.33- O N
N,O-Diacetylbisoprolol n/a 25mg
0025
O
O

O
N
MM0460.34- 5-[[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]methyl]-3- O

87844-84-6 25mg
0025 (1-methylethyl)-2-oxazolidinone
O
O

O
MM0460.35- HO OH
(E)-4-(Carboxymethoxy)-4-oxobut-2-enoic Acid 2169861-24-7 25mg O
0025 O O

OH OH

MM0460.36- O N O
1,1'-[(1-Methylethyl)imino]bis(1-(4-((2-isopropoxyethoxy)
n/a 100mg
O O
0100 methyl)phenoxy)propan-2-ol O O

O
MM0460.37- O
[[4-(Hydroxymethyl)phenoxy]methyl]oxirane 4204-78-8 25mg HO
0025
OH
H
O N O
MM0460.38- N-[2-Hydroxy-3-[4-(2-isopropoxyethoxymethyl)phenoxy]
1346602-59-2 25mg
0025 propyl]formamide (N-Desisopropyl-N-formyl Bisoprolol) O
O

Bitoscanate
N
C
MM1837.00 Bitoscanate 4044-65-9 250mg S
C
S
N

Boldenone
OH

H
MM0864.00 Boldenone 846-48-0 100mg
H H
O

Boldenone Cypionate
O

O
MM3718.00-
Boldenone Cypionate 106505-90-2 100mg H

H H
0100 O

Boldenone Undecylenate
O

MM3560.00 Boldenone Undecylenate 13103-34-9 100mg H


H

H
O

Bortezomib

N-[(1S)-2-Amino-1-benzyl-2-oxoethyl]pyrazine-2- O
MM3368.02 289472-80-6 100mg N NH2
carboxamide N
H
O
N

MM3368.02- N-[(1S)-2-Amino-1-benzyl-2-oxoethyl]pyrazine-2- O
289472-80-6 25mg N NH2
0025 carboxamide N
H
O
N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-79
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

( S)- -Amino-N-[(1R)-1-[(3aS,4S,6S,7aR)-hexahydro-3a,5,5- H

MM3368.04- trimethyl-4,6-methano-1,3,2-benzodioxaborol-2-yl]-3- H
N
O
B
O
H

HCl
H 2N H

methylbutyl]benzenepropanamide Hydrochloride (Bortezomib


205393-21-1 25mg O
0025
Intermediate II)

MM3368.07- (2S)-3-Phenyl-2-[[(pyrazin-2-yl)carbonyl]amino]propanoic O
114457-94-2 25mg N OH
0025 Acid N
H
O
N

Bosentan Monohydrate
O O
S
NH O
O
N

MM3369.00 Bosentan Monohydrate 157212-55-0 250mg N


N O
H2O

OH

4-tert-Butyl-N-[6-chloro-5-(2-methoxyphenoxy)-2,2'-
O O
S
bipyrimidin-4-yl]benzenesulfonamide NH O
MM3369.01- O
N
Related compound A (USP): 4-(tert-butyl)-N-[6-chloro-5-(2- 150727-06-3 25mg N
0025 N Cl

methoxyphenoxy)-(2,2'-bipyrimidin)-4-yl] N

benzenesulfonamide
O O
4-(tert-Butyl)benzenesulfonamide S
NH2
MM3369.02 Related compound E (USP): 4-(tert-butyl) 6292-59-7 100mg
benzenesulfonamide
O O
4-(tert-Butyl)benzenesulfonamide S
MM3369.02- NH2
Related compound E (USP): 4-(tert-butyl) 6292-59-7 25mg
0025
benzenesulfonamide
Cl O
4,6-Dichloro-5-(2-methoxyphenoxy)-2,2'-bipyrimidine O
N
MM3369.03 Related compound D (USP): 4,6-dichloro-5-(2- 150728-13-5 100mg N
N Cl

methoxyphenoxy)-2,2'-bipyrimidine N

Cl O
4,6-Dichloro-5-(2-methoxyphenoxy)-2,2'-bipyrimidine O
MM3369.03- N
Related compound D (USP): 4,6-dichloro-5-(2- 150728-13-5 25mg N
N Cl
0025
methoxyphenoxy)-2,2'-bipyrimidine N

OH O
O
4,6-Dihydroxy-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl) N
MM3369.04 329923-15-1 100mg N
pyrimidine N OH
N

OH O
O
MM3369.04- 4,6-Dihydroxy-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl) N
329923-15-1 25mg N
N OH
0025 pyrimidine
N

Brexpiprazole
H
O N O
N

MM3702.00 Brexpiprazole 913611-97-9 250mg


N

NH
N
HCl
MM3702.01 1-Benzo[b]thien-4-yl-piperazine Hydrochloride 913614-18-3 100mg
S

NH

MM3702.01- N
HCl
1-Benzo[b]thien-4-yl-piperazine Hydrochloride 913614-18-3 25mg
0025
S

Brimonidine Tartrate
N OH O
MM1324.00-
Brimonidine Tartrate
N Br HO
HN OH
70359-46-5 250mg N N
O OH

0250 H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-80
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP): N-(Imidazolidin-2-ylidene)quinoxalin-6- N


HN
MM1324.01 91147-43-2 100mg
amine N
N
H

N
MM1324.01- Impurity A (EP): N-(Imidazolidin-2-ylidene)quinoxalin-6- N
HN
91147-43-2 25mg
0025 amine N
N
H

N
MM1324.02- Impurity B (EP): 5-Bromoquinoxalin-6-amine N Br
Related compound A (USP): 5-Bromoquinoxalin-6-amine
50358-63-9 25mg
0025
NH2

N
N
MM1324.03 Impurity C (EP): Quinoxalin-6-amine 6298-37-9 100mg
NH2

N
MM1324.03- N
Impurity C (EP): Quinoxalin-6-amine 6298-37-9 25mg
0025
NH2

N
Impurity D (EP): 1-(5-Bromoquinoxalin-6-yl)thiourea N Br
MM1324.04-
Related compound B (USP): 1-(5-Bromoquinoxalin-6-yl) 842138-74-3 25mg S
0025 thiourea N
H
NH2

N
MM1324.10- N Br
S
1-(2-Aminoethyl)-3-(5-bromoquinoxalin-6-yl)thiourea 134892-47-0 25mg NH2
0025 N N
H H

MM1324.13- N Cl
N
5-Chloro-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine 91147-46-5 25mg
0025 N N
H H

Brinzolamide
O O
O S S
O N O
S

MM1300.00 Brinzolamide 138890-62-7 250mg H 2N

HN

O O
O S S
MM1300.03- (4S)-3,4-Dihydro-4-hydroxy-2-(3-methoxypropyl)-2H-thieno O N O
S
154127-42-1 25mg H2 N
0025 [3,2-e]-1,2-thiazine-6-sulfonamide 1,1-Dioxide OH

O O
O S S
O N O
(4R)-4-(Isopropylamino)-2-(3-methoxypropyl)-3,4-dihydro-2H- S
H 2N
MM1300.05 n/a 100mg HN
thieno[3,2-e]-1,2-thiazine-6-sulfonamide 1,1-Dioxide
O O
O S S
O N O
MM1300.05- (4R)-4-(Isopropylamino)-2-(3-methoxypropyl)-3,4-dihydro-2H- S
H 2N
n/a 25mg HN
0025 thieno[3,2-e]-1,2-thiazine-6-sulfonamide 1,1-Dioxide
O O
(4R)-4-(Ethylamino)-2-(3-methoxypropyl)-3,4-dihydro-2H- O S S
O N O
S
HN
MM1300.06 thieno[3,2-e]-1,2-thiazine-6-(N-methylsulfonyl)sulfonamide n/a 100mg S
HN
O
O
1,1-Dioxide (Brinzolamide Methanesulfonimide Analogue)
O O
(4R)-4-(Ethylamino)-2-(3-methoxypropyl)-3,4-dihydro-2H- O S S
O N O
MM1300.06- S
HN
thieno[3,2-e]-1,2-thiazine-6-(N-methylsulfonyl)sulfonamide n/a 25mg S
HN
0025 O
O
1,1-Dioxide (Brinzolamide Methanesulfonimide Analogue)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-81
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Brivaracetam
O

H 2N
MM3939.00- N
Brivaracetam 357336-20-0 250mg O
0250

Bromazepam
H O
N

Br N
MM0064.00 Bromazepam 1812-30-2 CS 100mg
N

NH2

O
Impurity A (EP): (2-Amino-5-bromophenyl)- Br
MM0064.01 1563-56-0 100mg
(pyridin-2-yl)methanone N

NH2

O
MM0064.01- Impurity A (EP): (2-Amino-5-bromophenyl)- Br
1563-56-0 25mg
0025 (pyridin-2-yl)methanone N

O
Cl
NH

MM0064.02- Impurity B (EP): N-[4-Bromo-2-(pyridin-2- O


41526-21-0 25mg Br
0025 ylcarbonyl)phenyl]-2-chloroacetamide
N

H O
N

Impurity C (EP): 7-Bromo-5-(6-methylpyridin-2- Br N


MM0064.09 868350-97-4 50mg
yl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one N

H
N O

Impurity D (EP): 3-Amino-6-bromo-4-(pyridin- Br NH2


MM0064.04 77616-97-8 50mg
2-yl)quinolin-2(1H)-one N

O
Br
NH

Impurity E (EP): 2-Bromo-N-[4-bromo-2-(pyridin- O


MM0064.07 1694-64-0 50mg Br
2-ylcarbonyl)phenyl]acetamide
N

Bromazine Hydrochloride

MM0640.02-
4-Bromo- -phenylbenzenemethanol (4-Bromobenzhydrol) 29334-16-5 25mg
0025 OH

Br

OH
N
MM1681.02 Deanol (2-(Dimethylamino)ethanol) 108-01-0 100mg

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-82
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Bromfenac Sodium Sesquihydrate


O NH2

MM3532.00 Bromfenac Sodium Sesquihydrate 120638-55-3 250mg Br


O
O

2
Na
+

2
H2 O
3

O N H2
MM3532.01- O
Bromfenac Methyl Ester n/a 25mg O
0025 Br

O N H2
MM3532.02- O
Bromfenac Ethyl Ester 102414-22-2 25mg O
0025 Br

O N H2
MM3532.03- O
Bromfenac Isopropyl Ester n/a 25mg O
0025 Br

O
H
O N

MM3532.08 7-(4-Bromobenzoyl)indolin-2-one (Bromfenac Lactam) 91713-91-6 100mg


Br

O
H
O N
MM3532.08-
7-(4-Bromobenzoyl)indolin-2-one (Bromfenac Lactam) 91713-91-6 25mg
0025
Br

Bromhexine Hydrochloride
Br

MM0065.00-
Bromhexine Hydrochloride 611-75-6 250mg Br
N
HCl

0250 NH2

Br
OH
Impurity A (EP): (2-Amino-3,5-
MM0005.01 50739-76-9 100mg
dibromophenyl)methanol NH2
Br

Br
OH
MM0005.01- Impurity A (EP): (2-Amino-3,5-
50739-76-9 25mg
0025 dibromophenyl)methanol NH2
Br

Br
O
Impurity B (EP): 2-Amino-3,5-
MM0005.02 50910-55-9 100mg
dibromobenzaldehyde NH2
Br

Br
O
MM0005.02- Impurity B (EP): 2-Amino-3,5-
50910-55-9 25mg
0025 dibromobenzaldehyde NH2
Br

Impurity C (EP): N-(2-Aminobenzyl)-N- N


MM0065.02 57365-08-9 100mg
methylcyclohexanamine NH2

MM0065.02- Impurity C (EP): N-(2-Aminobenzyl)-N- N


57365-08-9 25mg
0025 methylcyclohexanamine NH2

Br
Impurity D (EP) as Dihydrochloride: N-(2-
MM0065.03 Amino-5-bromobenzyl)-N-methyl- 10076-98-9 100mg N HCl
2

cyclohexanamine Dihydrochloride NH2

Br

MM0065.03- Impurity D (EP) as Dihydrochloride: N-(2-


Amino-5-bromobenzyl)-N-methyl- 10076-98-9 25mg N HCl
2
0025 cyclohexanamine Dihydrochloride NH2

Br

Impurity E (EP) as Chloride: (3RS)-6,8-


MM0065.08 Dibromo-3-cyclohexyl-3-methyl-1,2,3,4- 1660957-93-6 100mg Br
Cl

tetrahydroquinazolin-3-ium Chloride HN N
+

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-83
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Br

MM0065.08- Impurity E (EP) as Chloride: (3RS)-6,8-


Dibromo-3-cyclohexyl-3-methyl-1,2,3,4- 1660957-93-6 25mg Br
Cl
0025 tetrahydroquinazolin-3-ium Chloride HN N
+

N-(2-Nitrobenzyl)-N-cyclohexyl-N- N

methylamine
MM0065.01 80638-08-0 100mg +
N
O O

MM0065.01- N-(2-Nitrobenzyl)-N-cyclohexyl-N- N

methylamine
80638-08-0 25mg +
0025 N
O O

Br

6,8-Dibromo-3-cyclohexyl-3,4- Br
MM0065.05
dihydro-2(1H)-quinazolinone
21237-84-3 100mg
HN N

Br

MM0065.05- 6,8-Dibromo-3-cyclohexyl-3,4- Br
dihydro-2(1H)-quinazolinone
21237-84-3 25mg
0025 HN N

Br

MM0065.09 Bromhexine N-Oxide n/a 100mg Br


N
+

O
NH2

Br

Bromhexine Levulinamide Hydrochloride (N-[2,4-Dibromo-6- N HCl


MM0065.11- Br

[[cyclohexyl(methyl)amino]methyl]phenyl]-4-oxo-pentanamide HN O
n/a 25mg
0025
Hydrochloride) O

Bromisoval
O

MM1128.01 Ethyl 2-Bromoisovalerate 609-12-1 100mg O


Br

Bromocriptine Mesilate
Br H
N O
H O
HN N N

MM1159.00 Bromocriptine Mesilate 22260-51-1 100mg O O


OH
H
N

O O
S
OH

Brompheniramine Maleate
O
N
OH
MM0060.00 Brompheniramine Maleate 980-71-2 500mg N
OH

O
Br

Cl

O
MM0090.00- Impurity A (EP) as Maleate: Chlorphenamine OH
113-92-8 250mg
0250 Maleate N
N
OH

Cl
O

Impurity B (EP) as Maleate: Dexchlorpheniramine OH


MM1114.00 2438-32-6 100mg OH
Maleate N
N
O

N
N
Impurity C (EP): (3RS)-N,N-Dimethyl-3-phenyl-
MM0059.01 86-21-5 100mg
3-(pyridin-2-yl)propan-1-amine (Pheniramine)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-84
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0059.00- Impurity C (EP) as Maleate: (3RS)-N,N-Dimethyl- N


N
O

OH
3-phenyl-3-(pyridin-2-yl)propan-1-amine 132-20-7 250mg OH

0250 Maleate (Pheniramine Maleate) O

MM1439.00- OH
Maleic Acid 110-16-7 250mg
0250 OH

H
N N N
MM0090.04 2,2'-Dipyridylamine 1202-34-2 100mg

H
N N N
MM0090.04-
2,2'-Dipyridylamine 1202-34-2 25mg
0025

N
HCl
MM0060.18 Brompheniramine N-Oxide Dihydrochloride n/a 100mg N
+

O
2

Br

OH
N
MM0060.19- O
Brompheniramine N-Oxide Maleate n/a 100mg +
N O
O
0100 Br OH

O
N
OH
MM0060.16 Desmethylbrompheniramine Maleate n/a 100mg N
H
OH

O
Br

O
N
MM0060.16- OH
Desmethylbrompheniramine Maleate n/a 25mg N
H
OH

0025 Br
O

Brotizolam
Br

MM1443.00 Brotizolam 57801-81-7 CS 250mg


N
Cl N
N
N

Broxyquinoline
OH
Br N

MM1841.00 Broxyquinoline 521-74-4 250mg

Br

Brucine
H N
O
H H
MM1714.00 Brucine 357-57-3 100mg O N
H
O O
H

Buclizine Hydrochloride
Cl
N
N

MM0475.00 Buclizine Hydrochloride 129-74-8 250mg HCl


2

Impurity A (BP): 1,4-Bis(4-chlorobenzhydryl)piperazine N


Cl

MM0380.04 346451-15-8 100mg N

(1,4-Bis[(4-chlorophenyl)phenylmethyl]piperazine) Cl

MM0380.04- Impurity A (BP): 1,4-Bis(4-chlorobenzhydryl)piperazine N


Cl

346451-15-8 25mg N

0025 (1,4-Bis[(4-chlorophenyl)phenylmethyl]piperazine) Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-85
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0380.09 4-Chlorobenzhydrol 119-56-2 100mg


OH

Cl

MM0380.09-
4-Chlorobenzhydrol 119-56-2 25mg
0025 OH

Cl

MM0380.10 4-Chlorobenzophenone 134-85-0 100mg


O

Cl

MM0380.10-
4-Chlorobenzophenone 134-85-0 25mg
0025 O

Cl

Cl
NH
1-(4-Chlorobenzhydryl)piperazine N

MM0380.01 ((RS)-1-[(4-Chlorophenyl)phenylmethyl]- 303-26-4 100mg


piperazine)

Cl
NH

MM0380.01- 1-(4-Chlorobenzhydryl)piperazine N

((RS)-1-[(4-Chlorophenyl)phenylmethyl]- 303-26-4 25mg


0025 piperazine)

Budesonide
OH
O

MM0204.00- HO O

Budesonide 51333-22-3 250mg H O

0250 H H
O

OH
O
Impurity A (EP): 11 ,16 ,17,21-Tetrahydroxy- HO OH

MM0204.01 pregna-1,4-diene-3,20-dione (16 -Hydroxy- 13951-70-7 100mg H OH

prednisolone) O
H H

OH
O

MM0204.01- Impurity A (EP): 11 ,16 ,17,21-Tetrahydroxy- HO OH

pregna-1,4-diene-3,20-dione (16 -Hydroxy- 13951-70-7 25mg H OH

0025
prednisolone) O
H H

OH
O

Impurity B (EP): 16 ,17-[(1RS)-Ethylidenebis(oxy)]- HO


H
O
O
MM0204.02 1040085-98-0 50mg
11 ,21-dihydroxypregna-1,4-diene-3,20-dione H H
O

O OH
Impurity C (EP): 16 ,17-[(1RS)-Butylidenebis(oxy)]-11 - HO O
MM0204.03- H
hydroxy-17-(hydroxymethyl)-D-homo-androsta-1,4-diene- 1040085-99-1 25mg O
H H H
0025 O
3,17a-dione
OH
O

MM0204.06- HO O
Impurity F (EP): 16a,17-[1-Methylethylidenebis(oxy)]-11ß,21- H O
638-94-8 25mg
0025 dihydroxypregna-1,4-diene-3,20-dione (Desonide) H H
O

Impurity G (EP): 16 ,17-[(1RS)-Butylidenebis(oxy)]-


OH
O

MM0204.07- 11 ,21-dihydroxypregn-4-ene-3,20-dione HO O

(1,2-Dihydrobudesonide) 137174-25-5 25mg H O

H H
Related compound G (USP): 16alpha,17-[butylidenebis
0025
O

(oxy)]-11beta, 21-dihydroxypregna-4-ene-3,20-dione
OH
O

MM0204.12- Impurity H (EP): 16 ,17-[(1RS)-Butylidenebis(oxy)]- H


O
O
313474-58-7 25mg
0025 21-hydroxypregna-1,4,9(11)-triene-3,20-dione H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-86
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
O

MM0204.13- Impurity I (EP): 11 ,17,21-Trihydroxy-3,20-dioxopregna- HO


H
OH
O
113930-13-5 25mg
0025 1,4-dien-16 -yl Butanoate O
H H O

OH
O

MM0204.14- Impurity J (EP): 16 ,17-[(1RS)-Butylidenebis(oxy)]-9 - HO


H
O
O
313474-59-8 25mg
0025 bromo-11 ,21-dihydroxypregna-1,4-diene-3,20-dione Br H
O

O
O
MM0204.15- Impurity K (EP): 16 ,17-[(1RS)-Butylidenebis(oxy)]-11 ,21- HO O
51333-05-2 25mg H O
0025 dihydroxypregna-1,4-diene-3,20-dione-21-acetate H H
O

Impurity L (EP): 16 ,17-[(1RS)-Butylidene-bis(oxy)]- O


OH

MM0204.16- 21-hydroxypregna-1,4-diene-3,11,20-trione O
H
O
O
216453-74-6 25mg
0025 Related compound L (USP): 16alpha,17-[butylidenebis H H
O
(oxy)]-21-hydroxypregna-1,4-diene-3,11,20-trione
O
OH
HO O
MM0204.08-
Budesonide 20-Carboxylic Acid 192057-49-1 25mg H O

0025 H H
O

O O
HO
MM0204.10- 11 ,16 -Dihydroxyandrosta-1,4-diene-3,17-dione H O
85234-64-6 25mg
0025 16-Butyrate O
H H

O
O
MM0204.18- HO O
Budesonide 21-Butanoate 2408495-96-3 25mg H O
0025 H H
O

Bufexamac
H
N

MM0179.00 Bufexamac 2438-72-4 500mg O


O
OH

OH

MM0179.01 Impurity A (EP): 2-(4-Butoxyphenyl)acetic Acid 4547-57-3 100mg O


O

OH
MM0179.01-
Impurity A (EP): 2-(4-Butoxyphenyl)acetic Acid 4547-57-3 25mg O
O
0025

Impurity B (EP): Methyl 2-(4-Butoxyphenyl)- O

MM0179.02 29056-06-2 100mg O


acetate O

Impurity C (EP): Butyl 2-(4-Butoxyphenyl)- O

MM0179.03 1185726-73-1 100mg O

acetate O

NH2

MM0179.04 Impurity D (EP): 2-(4-Butoxyphenyl)acetamide 3413-59-0 100mg O


O

NH2
MM0179.04-
Impurity D (EP): 2-(4-Butoxyphenyl)acetamide 3413-59-0 25mg O
O
0025

Buflomedil Hydrochloride
O O

MM0066.00 Buflomedil Hydrochloride 35543-24-9 500mg N

O O HCl

Impurity A (EP) as Hydrochloride: 4-(Pyrrolidin-


OH O
MM0066.01- 1-yl)-1-(2-hydroxy-4,6-dimethoxyphenyl)- N
70585-57-8 25mg
0025 butan-1-one Hydrochloride O O HCl

(o-Desmethyl-Buflomedil Hydrochloride)
Impurity B (EP) as Hydrochloride: 4-(Pyrrolidin-
O O
1-yl)-1-(4-hydroxy-2,6-dimethoxyphenyl)- N
MM0066.02 70585-59-0 100mg
butan-1-one Hydrochloride HO O
HCl

(p-Desmethyl-Buflomedil Hydrochloride)
Impurity B (EP) as Hydrochloride: 4-(Pyrrolidin-
O O
MM0066.02- 1-yl)-1-(4-hydroxy-2,6-dimethoxyphenyl)- N
70585-59-0 25mg
0025 butan-1-one Hydrochloride HO O
HCl

(p-Desmethyl-Buflomedil Hydrochloride)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-87
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0066.05 1,3,5-Trimethoxybenzene 621-23-8 100mg


O O

O
MM0066.05-
1,3,5-Trimethoxybenzene 621-23-8 25mg
0025
O O

Cl

MM0066.06 1-Chloro-3,5-dimethoxybenzene 7051-16-3 100mg


O O

Cl
MM0066.06-
1-Chloro-3,5-dimethoxybenzene 7051-16-3 25mg
0025
O O

MM0066.07 1,3-Dimethoxybenzene 151-10-0 100mg


O O

MM0066.08 1,2,4-Trimethoxybenzene 135-77-3 100mg


O O

Br

MM0066.09 1-Bromo-3,5-dimethoxybenzene 20469-65-2 100mg


O O

Br
MM0066.09-
1-Bromo-3,5-dimethoxybenzene 20469-65-2 25mg
0025
O O

Br

MM0066.10 1,3,5-Tribromobenzene 626-39-1 100mg


Br Br

Br
MM0066.10-
1,3,5-Tribromobenzene 626-39-1 25mg
0025
Br Br

O O
O
MM0066.12- N
+
HCl
Buflomedil N-Oxide Hydrochloride n/a 25mg
0025 O O

Buformin Hydrochloride
NH NH HCl

MM1843.00 Buformin Hydrochloride 1190-53-0 100mg H2 N N N


H H

Bumetanide
O O O
S
H2 N OH
MM1290.00-
Bumetanide 28395-03-1 250mg O
0250 HN

O O O
Impurity A (EP): 3-Nitro-4-phenoxy-5-sulphamoylbenzoic H2 N
S
OH

MM1290.01 Acid O
28328-53-2 100mg
Related compound B (USP): 3-Nitro-4-phenoxy-5- O
N
+

O
sulfamoylbenzoic Acid
O O O
Impurity A (EP): 3-Nitro-4-phenoxy-5-sulphamoylbenzoic H2 N
S
OH
MM1290.01- Acid O
28328-53-2 25mg
0025 Related compound B (USP): 3-Nitro-4-phenoxy-5- O
N
+

O
sulfamoylbenzoic Acid

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-88
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O O O

Impurity B (EP): 3-Amino-4-phenoxy-5-sulfamoylbenzoic H 2N


S
OH
Acid O
Related compound A (USP): 3-Amino-4-phenoxy-5-
MM1290.02 28328-54-3 100mg
NH2

sulfamoylbenzoic Acid
O O O
S
H2 N O
Impurity C (EP): Butyl 3-(Butylamino)-4-phenoxy-5- O
MM1290.03 32643-00-8 100mg
sulfamoylbenzoate HN

O O O
S
H2 N O
MM1290.03- Impurity C (EP): Butyl 3-(Butylamino)-4-phenoxy-5- O
32643-00-8 25mg
0025 sulfamoylbenzoate HN

Bunolol Hydrochloride
OH
H

MM0642.00 Bunolol Hydrochloride 31969-05-8 100mg O


O N HCl

Buparvaquone
O

MM3576.00 Buparvaquone 88426-33-9 250mg OH


O

Buphenine Hydrochloride
OH

MM0710.00 Buphenine Hydrochloride 849-55-8 500mg HO


HN
HCl

Bupivacaine Hydrochloride
MM0613.00- H
N HCl H2 O
N
Bupivacaine Hydrochloride Monohydrate 73360-54-0 250mg O
0250

H
Impurity A (EP): N-(2,6-Dimethylphenyl)pyridine- N
MM0368.03 39627-98-0 100mg N
2-carboxamide O

H
MM0368.03- Impurity A (EP): N-(2,6-Dimethylphenyl)pyridine- N
39627-98-0 25mg N
0025 2-carboxamide O

Impurity B (EP): (2RS)-N-(2,6-Dimethylphenyl)piperidine-2-


H
MM0368.08 carboxamide 15883-20-2 100mg N
N
Related compound B (USP): N-(2,6-dimethylphenyl)piperidine- O
H

2-carboxamide
Impurity B (EP): (2RS)-N-(2,6-Dimethylphenyl)piperidine-2-
H
MM0368.08- carboxamide 15883-20-2 25mg N
N
0025 Related compound B (USP): N-(2,6-dimethylphenyl)piperidine- O
H

2-carboxamide
Cl
Impurity D (EP): (2RS)-2,6-Dichloro-N-(2,6- H
N
Cl
MM0613.04 1037184-07-8 50mg
dimethylphenyl)hexanamide O

Impurity E (EP): 6-(Butylamino)-N-(2,6-dimethylphenyl)


H
MM0613.08- hexanamide N
N
1330172-81-0 25mg H
O
0025 Related compound A (USP): 6-(butylamino)-N-(2,6-
dimethylphenyl)hexanamide
Impurity E (EP) as Hydrochloride: 6-(Butylamino)-N-
MM0613.05- (2,6-dimethylphenyl)hexanamide Hydrochloride H
N
HCl

N
H
Related compound A (USP): 6-(butylamino)-N-(2,6-
2518187-63-6 25mg O
0025
dimethylphenyl)hexanamide

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-89
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N H2
MM0102.02 Impurity F (EP): 2,6-Dimethylaniline 87-62-7 100mg

MM0613.07 Bupivacaine N-Oxide 1346597-81-6 100mg N


N
+

O
O

Buprenorphine
N

MM0120.00- OH
Buprenorphine 52485-79-7 CS 250mg
0250 H
HO O O

H
N
Impurity B (EP): (2S)-2-(4,5 -Epoxy-3-hydroxy-6-methoxy-
MM0120.10- OH
6 ,14-ethano-14 -morphinan-7 -yl)-3,3-dimethylbutan-2-ol 78715-23-8 25mg
0025 H
(Norbuprenorphine) HO O O

Impurity C (EP): 4,5 -Epoxy-7 -[(1S)-1-hydroxy-1,2,2-


N
trimethylpropyl]-3,6-dimethoxy-6 ,14-ethano-14 -morphinan- N
MM0120.11- OH
17-carbonitrile (4,5-Epoxy-7-[(1S)-1-hydroxy-1,2,2- 16614-60-1 25mg
0025 H
trimethylpropyl]-3,6-dimethoxy-6,14-ethano-14-morphinan- O O O

17-carbonitrile)
Impurity E (EP): (2S)-2-[17-(Cyclopropylmethyl)-4,5 -epoxy- N

MM0120.03- 3,6-dihydroxy-6 ,14-ethano-14 -morphinan-7 -yl]-3,3- OH


130668-48-3 25mg
0025 dimethylbutan-2-ol (6-O-Desmethylbuprenorphine; Desmethyl H
HO O OH
Buprenorphine)
O +
N

OH
MM0120.15 Buprenorphine N-Oxide 112242-17-8 100mg
H
HO O O

O +
N

MM0120.15- OH
Buprenorphine N-Oxide 112242-17-8 25mg
0025 H
HO O O

Buprenorphine Hydrochloride
N HCl

OH
MM1237.00 Buprenorphine Hydrochloride 53152-21-9 CS 250mg
H
HO O O

H
N
Impurity B (EP): (2S)-2-(4,5 -Epoxy-3-hydroxy-6-methoxy-
MM0120.10- OH
6 ,14-ethano-14 -morphinan-7 -yl)-3,3-dimethylbutan-2-ol 78715-23-8 25mg
0025 H
(Norbuprenorphine) HO O O

Impurity C (EP): 4,5 -Epoxy-7 -[(1S)-1-hydroxy-1,2,2-


N
trimethylpropyl]-3,6-dimethoxy-6 ,14-ethano-14 -morphinan- N
MM0120.11- OH
17-carbonitrile (4,5-Epoxy-7-[(1S)-1-hydroxy-1,2,2- 16614-60-1 25mg
0025 H
trimethylpropyl]-3,6-dimethoxy-6,14-ethano-14-morphinan- O O O

17-carbonitrile)
Impurity E (EP): (2S)-2-[17-(Cyclopropylmethyl)-4,5 -epoxy- N

MM0120.03- 3,6-dihydroxy-6 ,14-ethano-14 -morphinan-7 -yl]-3,3- OH


130668-48-3 25mg
0025 dimethylbutan-2-ol (6-O-Desmethylbuprenorphine; Desmethyl H
HO O OH
Buprenorphine)
O +
N

OH
MM0120.15 Buprenorphine N-Oxide 112242-17-8 100mg
H
HO O O

O +
N

MM0120.15- OH
Buprenorphine N-Oxide 112242-17-8 25mg
0025 H
HO O O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-90
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Bupropion Hydrochloride
O
H
Cl N
MM0745.00 Bupropion Hydrochloride 31677-93-7 100mg HCl

2-(tert-Butylamino)-4'-chloropropiophenone
O
Hydrochloride H
N
HCl

Related compound A (USP): 2-(tert-butylamino)-4'-


MM0745.02 1049718-72-0 100mg
Cl

chloropropiophenone
2-(tert-Butylamino)-4'-chloropropiophenone
O
MM0745.02- Hydrochloride H
N
HCl

0025 Related compound A (USP): 2-(tert-butylamino)-4'- 1049718-72-0 25mg


Cl

chloropropiophenone
2-(tert-Butylamino)-3'-bromopropiophenone
O
Hydrochloride Br
H
N
HCl

Related compound B (USP): 2-(tert-butylamino)-3'-


MM0745.03 1049718-43-5 100mg
bromopropiophenone
2-(tert-Butylamino)-3'-bromopropiophenone
O
MM0745.03- Hydrochloride Br
H
N
HCl

0025 Related compound B (USP): 2-(tert-butylamino)-3'- 1049718-43-5 25mg


bromopropiophenone
O
1-(3-Chlorophenyl)-2-hydroxy-1-propanone Cl OH
MM0745.04 Related compound C (USP): 1-(3-chlorophenyl)-2- 152943-33-4 100mg
hydroxypropan-1-one
O
2-(tert-Butylamino)propiophenone H
N
HCl

Hydrochloride
MM0745.05 63199-74-6 100mg

O
MM0745.05- 2-(tert-Butylamino)propiophenone H
N
HCl
63199-74-6 25mg
0025 Hydrochloride
O
Cl O
MM0745.06 1-(3-Chlorophenyl)-1,2-propandione 10557-17-2 100mg

O
Cl
MM0745.08 3-Chloropropiophenone 34841-35-5 100mg

O
MM0745.08- Cl
3-Chloropropiophenone 34841-35-5 25mg
0025

AND Enantiomer

MM0745.14- O
Hydroxybupropion (as (RS,RS)-cyclic Hemiketal) 233600-52-7 25mg Cl
HO
NH

0025

O
2-Bromo-1-(3-chlorophenyl)propan-1-one (2-Bromo-3'- Cl Br
MM0745.15 chloropropiophenone) 34911-51-8 100mg
Related compound G (USP): 2-Bromo-1-(3-chlorophenyl)

O
MM0745.16- Cl
3-Chlorobenzoic Acid 535-80-8 25mg OH
0025

Buspirone Hydrochloride
O

MM0464.00 Buspirone Hydrochloride 33386-08-2 500mg O


N
N N
HCl

Impurity A (EP) as Dihydrochloride: 2-(Piperazin- HN

MM0464.02 1-yl)pyrimidine Dihydrochloride 94021-22-4 100mg N N


HCl
2
N
Related compound A (USP): 2-(Piperazin-1-yl)pyrimidine

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-91
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP) as Dihydrochloride: 2-(Piperazin- HN


MM0464.02-
1-yl)pyrimidine Dihydrochloride 94021-22-4 25mg N N
HCl
2
N
0025 Related compound A (USP): 2-(Piperazin-1-yl)pyrimidine
+
Impurity B (EP) as Bromide: 8-(Pyrimidin-2-yl)- N
N N Br
MM0464.05 81461-73-6 100mg
8-aza-5-azoniaspiro[4.5]decane Bromide N

+
MM0464.05- Impurity B (EP) as Bromide: 8-(Pyrimidin-2-yl)- N
N N Br
81461-73-6 25mg
0025 8-aza-5-azoniaspiro[4.5]decane Bromide N

Impurity C (EP): 2,2'-[Butane-1,4-diylbis(piperazine- N N


N
N
MM0464.04 257877-45-5 50mg
1,4-diyl)]dipyrimidine N

N
N

O
N
N N

Impurity D (EP): 2,2'-[Oxybis[butane-1,4-diyl- N


N
MM0464.06 n/a 50mg
(piperazine-1,4-diyl)]]dipyrimidine N N

MM0464.19- Impurity E (EP) as Hydrochloride: [1-[2-Oxo-2-[[4-[4- O


HCl
O HN

(pyrimidin-2-yl)piperazin-1-yl]butyl]amino]ethyl]- 257877-46-6 25mg OH


N
N N

0025 cyclopentyl]acetic Acid Hydrochloride N

Impurity F (EP) as Dioxalate: 4-[4-(Pyrimidin-2-yl)--yl]butyl O

MM0464.20- [1-[2-Oxo-2-[[4-[4-(pyrimidin- O

O
HN

N
N
N N
O OH

n/a 25mg
-yl)piperazin-1-yl]butyl]amino]ethyl]cyclopentyl]-
O OH
N N N 2

0025 N

acetate Dioxalate
N
Impurity G (EP): 2,2'-(Piperazine-1,4-diyl)dipyrimidine
N N
MM0464.12 Related compound G (USP): 1,4-Di(pyrimidin-2-yl) 84746-24-7 50mg N N

piperazine N

MM0464.21- Impurity H (EP) as Dioxalate: Bis[4-[4-(pyrimidin-2-) O O


O

O OH
N

piperazin-1-yl]butyl] (Cyclopentane-1,1-diyl)di- n/a 25mg O


N
N N
N

N
N
O OH
2

0025 acetate Dioxalate N

MM0464.14- Impurity I (EP): 8-[4-[4-(5-Chloropyrimidin-2-yl)- O

piperazin-1-yl]butyl]-8-azaspiro[4.5]decane- n/a 25mg O


N
N N

0025 7,9-dione N
Cl

Impurity J (EP) as Oxalate: 4-(7,9-Dioxo-8-[4.5]dec-8-yl)butyl H


N
N

[1-[2-Oxo-2- O

O
O
O
N

N
N

MM0464.22 n/a 50mg


[[4-[4-(pyrimidin-2-yl)piperazin-1-yl]butyl]-
N
O OH
O

amino]ethyl]cyclopentyl]acetate Oxalate O OH

O
Impurity K (EP): 8-Azaspiro[4,5]decane-7,9-dione
MM0464.08 Related compound K (USP): 8-azaspiro[4.5]decane-7,9- 1075-89-4 100mg NH
dione
O

O
Impurity K (EP): 8-Azaspiro[4,5]decane-7,9-dione
MM0464.08-
Related compound K (USP): 8-azaspiro[4.5]decane-7,9- 1075-89-4 25mg NH
0025 dione
O

Impurity L (EP): 8-(4-Chlorobutyl)-8-azaspiro[4.5]-


O
decane-7,9-dione
MM0464.09 N
Related compound L (USP): 8-(4-Chlorobutyl)-8-azaspiro
21098-11-3 50mg Cl
O
[4.5]decane-7,9-dione
O
Impurity M (EP): 8-(4-Bromobutyl)-8-azaspiro[4.5]-
MM0464.16 80827-62-9 50mg N
decane-7,9-dione O
Br

Impurity N (EP): 8,8'-(Butane-1,4-diyl)bis(8-azaspiro- O

[4.5]decane-7,9-dione) N
N
O

Related compound N (USP): 8,8'-(Butane-1,4-diyl)bis(8-


MM0464.10 257877-44-4 50mg O
O

azaspiro[4.5]decane-7,9-dione
HO
N
MM0464.17- N N
4-[4-(Pyrimidin-2-yl)piperazin-1-yl]butanol Hydrochloride n/a 25mg HCl
0025 N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-92
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
O
OH
O HO
MM0464.31- N
N
+ O
Buspirone N-Oxide Oxalate 1797880-63-7 25mg O N N
0025 N

O
O
MM0464.25 7,9-Dioxo-8-azaspiro[4.5]decane-8-butanoic Acid 105920-65-8 100mg N
OH
O

O
MM0464.25- O
7,9-Dioxo-8-azaspiro[4.5]decane-8-butanoic Acid 105920-65-8 25mg N
OH
0025 O

Busulfan
O O

MM0374.00 Busulfan 55-98-1 250mg S


O
O

O
S
O

Butacaine Sulfate
O
O O

MM1638.00 Butacaine Sulfate 149-15-5 250mg H2 N


O N
HO
S
OH

O
MM1638.01- O
+
O N
Butacaine N-Oxide n/a 25mg H 2N
0025

O
MM1638.02- O
+ HCl
O N
Butacaine N-Oxide Hydrochloride n/a 25mg H 2N
0025

Butafosfan
O
H H
MM3311.00 Butafosfan 17316-67-5 250mg N P
OH

Butalamine Hydrochloride
H
N O
N
N

MM1845.00 Butalamine Hydrochloride 56974-46-0 50mg N


HCl

O H
+ N O
N
MM1845.02- N
N
Butalamine N-Oxide n/a 25mg
0025

Butalbital
H
O N O
MM0774.00-
Butalbital 77-26-9 CS 250mg NH
0250
O

H
O N O

MM0899.00 5,5-Diallybarbituric acid (Allobarbital) 52-43-7 CS 100mg NH

Butamben
O

MM1802.00 Butamben 94-25-7 250mg O

H 2N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-93
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Butamirate Citrate
O
OH
O O

MM3771.00 Butamirate Citrate 18109-81-4 250mg O


O
N
OH
OH
OH

O
OH
OH
O
MM0606.00 Butetamate Citrate 13900-12-4 500mg O
N OH
OH
O
O

OH
MM1030.05 (2RS)-2-Phenylbutanoic Acid 90-27-7 100mg
O

MM1030.05- OH
(2RS)-2-Phenylbutanoic Acid 90-27-7 25mg
0025
O

O
MM3771.01- O
O N
2-[2-(Diethylamino)ethoxy]ethyl 2-Phenylacetate 47092-75-1 100mg
0100
O

MM3771.02 N,N-Diethyl-2-phenylbutanamide 92321-53-4 100mg N

O
MM3771.02-
N,N-Diethyl-2-phenylbutanamide 92321-53-4 25mg N
0025

MM3771.03- N
4-Ethylmorpholine 100-74-3 100mg
0100 O

Butobarbital
H
O N O

MM1625.00 Butobarbital 77-28-1 CS 100mg NH

Butoconazole Nitrate
Cl
O

MM1637.00 Butoconazole Nitrate 64872-77-1 250mg Cl


Cl S

N
N
HO
N
+

Cl
MM1637.03- Cl S O HCl
Butoconazole Sulfoxide Hydrochloride n/a 25mg N
0025 Cl N

Cl

MM1637.02- O
Cl S
Butoconazole Sulfone n/a 25mg O
0025 N
Cl N

Butorphanol Tartrate
N OH O

MM1192.00 Butorphanol Tartrate 58786-99-5 100mg HO


HO

O OH
OH

HO

O
+
N

MM1192.01 Butorphanol N-Oxide 112269-63-3 100mg HO

HO

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-94
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
+
N
MM1192.01-
Butorphanol N-Oxide 112269-63-3 25mg HO
0025
HO

Butyl Parahydroxybenzoate
O

MM0496.00 Butyl Parahydroxybenzoate 94-26-8 500mg O

HO

O
MM0045.01-
Impurity A (EP): 4-Hydroxybenzoic Acid 99-96-7 250mg OH
0250
HO

O
MM0431.00- Impurity B (EP): Methyl 4-Hydroxybenzoate (Methyl O
99-76-3 250mg
0250 Parahydroxybenzoate)
HO

O
MM0498.00- Impurity C (EP): Ethyl 4-Hydroxybenzoate (Ethyl O
120-47-8 250mg
0250 Parahydroxybenzoate) HO

O
MM0432.00- Impurity D (EP): Propyl 4-Hydroxybenzoate O
94-13-3 250mg
0250 (Propyl Parahydroxybenzoate) HO

O
Impurity E (EP): 2-Methylpropyl 4-Hydroxybenzoate (Isobutyl O
MM0496.05 4247-02-3 100mg
Parahydroxybenzoate) HO

O
MM0496.05- Impurity E (EP): 2-Methylpropyl 4-Hydroxybenzoate (Isobutyl O
4247-02-3 25mg
0025 Parahydroxybenzoate) HO

Butylene Glycol

MM0839.00 Butylene Glycol (Butane-1,3-diol) 107-88-0 250mg


HO OH

Butylhydroxyanisole
OH
OH

MM1179.00 Butylhydroxyanisole 25013-16-5 250mg O


O

Butylhydroxytoluene

MM0679.00- OH
Butylhydroxytoluene 128-37-0 250mg
0250

MM0679.01- OH
2,6-Di-tert-butyl-4-hydroxymethylphenol 88-26-6 25mg
0025 HO

Cabazitaxel
O O O
O
O
O
MM3517.00- N
H

Cabazitaxel
H O
H O
HO O
183133-96-2 250mg O OH O

0250 O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-95
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cabozantinib L-Malate
N O

O
MM3947.00- O
O
F
HO
OH
O O
Cabozantinib (S)-Malate 1140909-48-3 250mg N N
O OH

H H
0250

Caffeine
O

N
MM0494.00- N
Caffeine 58-08-2 250mg
0250
O N N

O
H
N N
MM0176.00 Impurity A (EP): Theophylline 58-55-9 500mg
O N N

O
H
Impurity B (EP): N-(6-Amino-1,3-dimethyl- N
N

MM0176.02 2,4-dioxo-1,2,3,4-tetrahydropyrimidin- 7597-60-6 100mg O


5-yl)formamide O N N H2

O
H
MM0176.02- Impurity B (EP): N-(6-Amino-1,3-dimethyl- N
N

2,4-dioxo-1,2,3,4-tetrahydropyrimidin- 7597-60-6 25mg O


0025 5-yl)formamide O N N H2

N
Impurity C (EP): 1,3,9-Trimethyl-3,9-dihydro- N
MM0494.03 519-32-4 50mg
1H-purine-2,6-dione (Isocaffeine) N
O N

HN N
MM0577.00 Impurity D (EP): Theobromine 83-67-0 500mg
O N N

O
Impurity E (EP) as Nitrate: N,1-Dimethyl-4- N O
N +
MM0494.06 (methylamino)-1H-imidazole-5-carbox- 209725-34-8 100mg H
N
HO N
O
HN
amide Nitrate (Caffeidine Nitrate)
O
Impurity E (EP) as Nitrate: N,1-Dimethyl-4- N O
MM0494.06- N +
(methylamino)-1H-imidazole-5-carbox- 209725-34-8 25mg H
N
HO N
O
HN
0025 amide Nitrate (Caffeidine Nitrate)
O
Impurity F (EP): 1,7-Dimethyl-3,7-dihydro- N
N
MM0494.04 1H-purine-2,6-dione (Paraxanthine; 611-59-6 50mg
1,7-Dimethylxanthine) O N N
H

N
MM0599.08- 8-Chloro-1,3,7-trimethyl-3,7-dihydro-1H-purine-2,6-dione (8- N
4921-49-7 25mg Cl
0025 Chlorocaffeine) O N N

O
+
Na N
O
Sodium 4-[N-Methyl-N-(N-methylaminocarbonyl)amino]-1- N
N
methylimidazole-5-carboxylate
MM0494.10 n/a 50mg
HN O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-96
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Caffeine Citrate
O
O OH
O
N
N
OH
MM1851.00 Caffeine Citrate 69-22-7 250mg O N N OH
OH
O

Calcifediol Monohydrate
H
HO

MM1549.00 Calcifediol Monohydrate 63283-36-3 100mg H H2 O

HO

Calcitriol
OH
H

MM0205.00 Calcitriol 32222-06-3 50mg H

HO OH

Calcium Citrate Tetrahydrate


O
O
OH O

MM3489.00 Calcium Citrate Tetrahydrate 5785-44-4 250mg Ca


2+

3
O
H2 O
4
O
O
2

Calcium Dobesilate Monohydrate


O O
2+
HO S

MM0632.00 Calcium Dobesilate Monohydrate n/a 250mg Ca O H2O

OH
2

HO
MM0632.01-
Impurity A (EP): Benzene-1,4-diol (Hydroquinone) 123-31-9 250mg
0250 OH

Calcium Folinate (Leucovorin Calcium)


O O
O
2+
Ca
H O
O N

MM0324.00 Calcium Folinate 1492-18-8 250mg N


N
N
H
H

O
O

H 2N N N
H H

O OH
Impurity A (EP): (2S)-2-(4-Aminobenzamido)pentanedioic O

MM0621.01- N
Acid ((2S)-2-[(4-Aminobenzoyl)amino]pentanedioic Acid; N- 4271-30-1 25mg H
OH
0025 H 2N
O
(4-Aminobenzoyl)-L-glutamic Acid)

Calcium Levofolinate Hydrate


O OH
Impurity A (EP): (2S)-2-(4-Aminobenzamido)pentanedioic O

MM0621.01- N
Acid ((2S)-2-[(4-Aminobenzoyl)amino]pentanedioic Acid; N- 4271-30-1 25mg H
OH
0025 H 2N
O
(4-Aminobenzoyl)-L-glutamic Acid)

Calcium Orotate Dihydrate


H
O N O

MM0881.00-
Orotic Acid 65-86-1 250mg NH
0250
O OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-97
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Calcium Pantothenate
O O

Calcium Pantothenate HO 2+
Ca
N O
MM1499.00 137-08-6 250mg OH
H
2

O
MM1463.01 Impurity A (EP): 3-Aminopropanoic Acid ( -Alanine) 107-95-9 100mg
H 2N OH

O
HO
MM1352.03- Impurity C (EP): (3R)-3-Hydroxy-4,4-dimethyldihydrofuran-2
599-04-2 25mg O
0025 (3H)-one (Pantolactone)

O
HO
Impurity C (EP) as Racemate: (3RS)-3-Hydroxy-4,4-
MM1352.04 79-50-5 100mg O
dimethyldihydrofuran-2(3H)-one (D,L-Pantolactone)

O
HO
MM1352.04- Impurity C (EP) as Racemate: (3RS)-3-Hydroxy-4,4-
79-50-5 25mg O
0025 dimethyldihydrofuran-2(3H)-one (D,L-Pantolactone)

O O
Impurity D (EP): Methyl 3-[(2R)-2,4-Dihydroxy-3,3- HO
MM1499.01 50692-78-9 50mg N O
H
dimethylbutanamido]propanoate (Methyl Pantothenate) OH

O O
HO
N O
MM1499.02 Ethyl Pantothenate 10527-68-1 50mg OH
H

Camphor, Racemic
AND Enantiomer

O
MM0103.00 Camphor, Racemic 76-22-2 250mg
H

O
MM0103.01 rac-Norcamphor 497-38-1 100mg

O
MM0103.01-
rac-Norcamphor 497-38-1 25mg
0025

D-Camphor

MM3327.00 D-Camphor 464-49-3 250mg

MM3327.01 L-Camphor 464-48-2 100mg

O
MM3327.01-
L-Camphor 464-48-2 25mg
0025
H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-98
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Canadine
O
O

MM3085.00 Canadine 522-97-4 100mg N


O
O

Candesartan Cilexetil
O O

O O O

MM0776.00- N N
Candesartan Cilexetil 145040-37-5 250mg N HN
N
N
0250 O

O
Impurity A (EP): Ethyl 2-Ethoxy-1-[[2'-(1H-tetrazol-5-yl) O
N N
MM0776.01- biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylate HN N
N
139481-58-6 25mg N
0025 Related compound A (USP): Ethyl 1-[2'-(1H-tetrazol-5-yl) O

biphenyl-4-yl]methyl-2-ethoxybenzimidazole-7-carboxylate
Impurity B (EP): (1RS)-1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl
O
2-Oxo-3-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-2,3- O O
O
MM0776.02- dihydro-1H-benzimidazole-4-carboxylate O
N N
869631-11-8 25mg HN N
0025 Related compound B (USP): 1-(Cyclohexyloxycarbonyloxy) N

N
ethyl 1-[2'-(1H- tetrazol-5-yl)biphenyl-4-yl]methyl-2-oxo-2,3- H O

dihydrobenzimidazole-7-carboxylate
O

MM0776.03- Impurity C (EP): (1RS)-1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl O

O
O
O

N N
3-[[2'-(1-Ethyl-1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-2-oxo- 1185255-99-5 25mg N
N N
0025 2,3-dihydro-1H-benzimidazole-4-carboxylate N
H O

Impurity D (EP): (1RS)-1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl


3-[[2'-(2-Ethyl-2H-tetrazol-5-yl)biphenyl-4-yl]methyl]-2-oxo- O
O

O
MM0776.04- 2,3-dihydro-1H-benzimidazole-4-carboxylate O
O
N N
1185256-03-4 25mg N N
0025 Related compound D (USP): 1-[(Cyclohexyloxy)carbonyl] N
N

oxyethyl 3-(2'-(2-ethyl-2H-tetrazol-5-yl)-[1,1'-biphenyl]-4- H O

ylmethyl)-2-oxo-2,3-dihydro-1H-benzimidazole-4-carboxylate
O

MM0776.05- Impurity E (EP): (1RS)-1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl O

O
O
O

N N
2-Ethoxy-1-[[2'-(1-ethyl-1H-tetrazol-5-yl)biphenyl-4-yl]methyl]- 914613-35-7 25mg N
N N

0025 1H-benzimidazole-7-carboxylate N
O

Impurity F (EP): (1RS)-1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl


2-Ethoxy-1-[[2'-(2-ethyl-2H-tetrazol-5-yl)-biphenyl-4-yl] O
O

O
O
MM0776.06- methyl]-1H-benzimidazole-7-carboxylate O
N N
914613-36-8 25mg N N

0025 Related compound F (USP): 1-(Cyclohexyloxycarbonyloxy) N


N

ethyl 2-ethoxy-1-[2'-(2-ethyl-2H-tetrazol-5-yl)biphenyl-4-yl] O

methyl-1H-benzimidazole-7-carboxylate
Impurity G (EP): 2-Ethoxy-1-[[2'-(1H-tetrazol-5-yl)- N
N
N

MM0776.09- biphenyl-4-yl]methyl]-1H-benzimidazole-7- N
H

carboxylic Acid (Candesartan) 139481-59-7 25mg O OH

0025 Related compound G (USP): 1-[2'-(1H-tetrazol-5-yl) N


O
N
biphenyl-4-yl]methyl-2-ethoxybenzimidazole-7-carboxylic acid
O

Impurity I (EP): Methyl 2-Ethoxy-1-[[2'-(1H-tetrazol-5- O

HN
N N
N
MM0776.10 yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7- 139481-69-9 100mg N
N

carboxylate (Candesartan Methyl Ester) O

MM0776.10- Impurity I (EP): Methyl 2-Ethoxy-1-[[2'-(1H-tetrazol-5- O

HN
N N
N

yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7- 139481-69-9 25mg N


N

0025 carboxylate (Candesartan Methyl Ester) O

O
N
Ethyl 1-[(2'-Cyanobiphenyl-4-yl)methyl]-2-ethoxy-1H- N
MM0776.11 139481-41-7 100mg N
benzimidazole-7-carboxylate O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-99
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
N
MM0776.11- Ethyl 1-[(2'-Cyanobiphenyl-4-yl)methyl]-2-ethoxy-1H- N
139481-41-7 25mg N
0025 benzimidazole-7-carboxylate O

O
O O
MM0776.17- O
O
N N
N2-Tritylcandesartan Cilexetil 886999-34-4 25mg N
N N
0025 N
O

OH
MM0776.18- N N
N N
N2-Tritylcandesartan 894806-43-0 25mg N

0025 N
O

N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20

Cantharidin
O

MM2534.00 Cantharidin 56-25-7 100mg O O

Capecitabine
O

HN O
F
N

MM0992.00 Capecitabine 154361-50-9 100mg O N

O OH

OH

O N NH2
Impurity A (EP): 4-Amino-1-(5-deoxy- -D-ribofuranosyl)-5- N
MM0992.05- O
fluoropyrimidin-2(1H)-one (5'-Deoxy-5-fluorocytidine) 66335-38-4 25mg F

0025 Related compound A (USP): 5'-deoxy-5-fluorocytidine HO


OH

H
O N O
Impurity B (EP): 1-(5-Deoxy- -D-ribofuranosyl)-5-
MM0992.06- O N
fluoropyrimidine-2,4(1H,3H)-dione (5'-Deoxy-5-fluorouridine) 3094-09-5 25mg F
0025 Related compound B (USP): 5'-deoxy-5-fluorouridine OH
HO

N H2
F
N

O N
Impurity C (EP): 1-(2,3-Di-O-acetyl-5-deoxy- -D-
MM0992.07 161599-46-8 100mg O
ribofuranosyl)-4-amino-5-fluoropyrimidin-2(1H)-one O O

O
O

N H2
F
N

O N
MM0992.07- Impurity C (EP): 1-(2,3-Di-O-acetyl-5-deoxy- -D-
161599-46-8 25mg O
0025 ribofuranosyl)-4-amino-5-fluoropyrimidin-2(1H)-one O O

O
O

HN O

MM0992.08- Impurity D (EP): (2RS)-2-Methylbutyl [1-(5-Deoxy- -D- N


F

ribofuranosyl)-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl] 910129-15-6 25mg O N


0025 carbamate O OH

OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-100
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HN O
Impurity E (EP): 3-Methylbutyl [1-(5-Deoxy- -D- F
N
MM0992.09-
ribofuranosyl)-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl] 162204-30-0 25mg O N
0025
carbamate O OH

OH

Impurity F (Pharmeuropa): Pentyl [5-fluoro-1- O

[(3aR,4R,6R,6aR)-6-methyl-2-oxotetrahydrofuro[3,4-d][1,3] HN O

MM0992.02- dioxol-4-yl]-2-oxo-1,2-dihydropyrimidin-4-yl]carbamate (2',3'- N


F

O-Carbonyl-5'-deoxy-5-fluoro-N4 921769-65-5 25mg O N

-(pentyloxycarbonyl)cytidine)
0025
O O

Related compound C (USP): 2',3'-O-carbonyl-5'-deoxy-5-fluoro- O


O

N4-(pentyloxycarbonyl)cytidine
O

HN O
F
N
Impurity G (EP): Pentyl [1-(2,3-Di-O-acetyl-5-deoxy- -D-
MM0992.10- O N
ribofuranosyl)-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl] 162204-20-8 25mg O
0025 O O
carbamate (Capecitabine Diacetate)
O
O

Caprylic Acid
O
MM3387.00 Caprylic Acid 124-07-2 250mg OH

Capsaicin
HO
MM0016.01- H

Dihydrocapsaicin 19408-84-5 25mg O


N

O
0025

N-[(4-Hydroxy-3-methoxyphenyl)methyl]octanamide (N- O
N
O

Vanillyloctanamide; Caprylic Vanillylamide)


MM1033.02 58493-47-3 100mg HO

MM1033.02- N-[(4-Hydroxy-3-methoxyphenyl)methyl]octanamide (N- O


N
H
O

58493-47-3 25mg
0025 Vanillyloctanamide; Caprylic Vanillylamide) HO

Captodiame Hydrochloride
S
N

MM1853.00 Captodiame Hydrochloride 904-04-1 50mg HCl

Captopril
O OH
O
MM0067.00-
Captopril 62571-86-2 250mg HS N
0250

Impurity A (EP): 1,1'-[Disulfanediylbis-


O OH

[(2S)-2-methyl-1-oxopropane-3,1-diyl]]- N S
S
O

N
MM0067.01 64806-05-9 100mg
bis[(2S)-pyrrolidine-2-carboxylic] Acid HO O
O

(Captopril Disulfide)
Impurity A (EP): 1,1'-[Disulfanediylbis-
O OH
MM0067.01- [(2S)-2-methyl-1-oxopropane-3,1-diyl]]- N S
S
O

N
64806-05-9 25mg
0025 bis[(2S)-pyrrolidine-2-carboxylic] Acid HO O
O

(Captopril Disulfide)
O
MM0067.07- Impurity B (EP): (2S)-1-[(2S)-3-Bromo-2- O OH

methylpropanoyl]pyrrolidine-2-carboxylic 80629-35-2 25mg Br N


0025 Acid

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-101
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
Impurity C (EP): (2RS)-2-Methyl-3-sulfanyl-
MM0067.02 26473-47-2 100mg HS OH
propanoic Acid

O
Impurity D (EP): (2RS)-3-Bromo-2-methyl-
MM0067.06 56970-78-6 100mg Br OH
propanoic Acid

O
O OH
Impurity E (EP): (2S)-1-[2-Methylpropanoyl]-
MM0067.08 23500-15-4 100mg N
pyrrolidine-2-carboxylic Acid

O
O OH
MM0067.08- Impurity E (EP): (2S)-1-[2-Methylpropanoyl]-
23500-15-4 25mg N
0025 pyrrolidine-2-carboxylic Acid

Impurity G (EP) as (S)-enantiomer: (2S)-3-(Acetylsulfanyl)-2- O O

MM0067.04 methylpropanoic Acid ((2S)-3-(Acetylthio)-2-methylpropanoic 76497-39-7 100mg S OH

Acid)
Impurity J (EP) as Hydrate: (2S)-1-[(2S)-3- O

(Acetylsulfanyl)-2-methylpropanoyl]- O O OH
H2 O
MM0067.05 801293-45-8 100mg S N
pyrrolidine-2-carboxylic Acid Hydrate
(Acetylcaptopril Hydrate)
Impurity J (EP) as Hydrate: (2S)-1-[(2S)-3- O
MM0067.05- (Acetylsulfanyl)-2-methylpropanoyl]- O O OH
H2 O
801293-45-8 25mg S N

0025 pyrrolidine-2-carboxylic Acid Hydrate


(Acetylcaptopril Hydrate)
O
MM0067.15- Impurity N (EP): 3,3'-Disulfanediylbis[(2S)-2- HO S
S OH
65134-74-9 25mg
0025 methylpropanoic] Acid O

Impurity O (EP): 1,1'-[Propane-2,2-diylbis-


MM0067.16- [sulfanediyl[(2S)-2-methyl-1-oxopropane- HO
O

N
O

S S
O
O

N
OH

n/a 25mg
0025 3,1-diyl]]]bis[(2S)-pyrrolidine-2-carboxylic]
Acid
O
O O

MM0067.03 Captopril Ethyl Ester 86938-12-7 100mg HS N

O
O O

MM0067.19 Captopril Methyl Ester 176036-41-2 100mg HS N

O
O O

MM0067.20 Captopril Isopropyl Ester 176036-42-3 100mg HS N

Caramiphen Hydrochloride
O

MM1585.00 Caramiphen Hydrochloride 125-85-9 50mg O


N HCl

Carbamazepine

N NH2
MM0076.00 Carbamazepine 298-46-4 250mg

N H2
Impurity A (EP): 10,11-Dihydro-5H-dibenzo[b,f]- O
azepine-5-carboxamide (10,11-Dihydro- N
MM0076.04 3564-73-6 100mg
carbamazepine)
Related compound A (USP): 10,11-dihydrocarbamazepine

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-102
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N H2
Impurity A (EP): 10,11-Dihydro-5H-dibenzo[b,f]- O
MM0076.04- azepine-5-carboxamide (10,11-Dihydro- N
carbamazepine)
3564-73-6 25mg
0025
Related compound A (USP): 10,11-dihydrocarbamazepine

N
MM0076.09 Impurity B (EP): 9-Methylacridine 611-64-3 100mg

MM0076.09- N
Impurity B (EP): 9-Methylacridine 611-64-3 25mg
0025

O O

Impurity C (EP): (5H-Dibenzo[b,f]azepin-5-yl- N N N H2


MM0076.12 1219170-51-0 100mg H
carbonyl)urea (N-Carbamoylcarbamazepine)

O O

MM0076.12- Impurity C (EP): (5H-Dibenzo[b,f]azepin-5-yl- N N N H2


1219170-51-0 25mg H
0025 carbonyl)urea (N-Carbamoylcarbamazepine)

Impurity D (EP): 5H-Dibenzo[b,f]azepine


MM0076.08 (Iminostilbene) 256-96-2 100mg
N
Related compound B (USP): 5H-Dibenz[b,f]azepine H

Impurity D (EP): 5H-Dibenzo[b,f]azepine


MM0076.08-
(Iminostilbene) 256-96-2 25mg
N
0025 Related compound B (USP): 5H-Dibenz[b,f]azepine H

Impurity E (EP): 10,11-Dihydro-5H-dibenzo[b,f]- NH


MM0076.06 494-19-9 100mg
azepine (Iminodibenzyl)

MM0076.06- Impurity E (EP): 10,11-Dihydro-5H-dibenzo[b,f]- NH


494-19-9 25mg
0025 azepine (Iminodibenzyl)

MM0076.18- Impurity F (EP): 5H-Dibenzo[b,f]azepine-5-carbonyl Chloride N Cl


33948-22-0 25mg
0025 (5-Chlorocarbonyliminostilbene)

Impurity G (EP): 10-Bromo-5H-dibenzo[b,f]azepine- N N H2


MM0076.05 59690-97-0 100mg
5-carboxamide (10-Bromocarbamazepine)
Br

MM0076.05- Impurity G (EP): 10-Bromo-5H-dibenzo[b,f]azepine- N N H2


59690-97-0 25mg
0025 5-carboxamide (10-Bromocarbamazepine)
Br

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-103
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N NH2
MM0076.01 Carbamazepine 10,11-Epoxide 36507-30-9 100mg
O

MM0076.01- N NH2
Carbamazepine 10,11-Epoxide 36507-30-9 25mg
0025 O

NH
MM0076.07 10-Hydroxyiminodibenzyl 4014-77-1 100mg

HO

MM0076.07- NH
10-Hydroxyiminodibenzyl 4014-77-1 25mg
0025
HO

N N H2
MM0076.10 10-Hydroxy-10,11-dihydrocarbamazepine 29331-92-8 100mg
HO

MM0076.10- N N H2
10-Hydroxy-10,11-dihydrocarbamazepine 29331-92-8 25mg
0025
HO

10-Methoxycarbamazepine (10-Methoxy-5H-dibenz[b,f] N N H2
MM0076.13 28721-09-7 100mg
azepine-5-carboxamide)
O

MM0076.13- 10-Methoxycarbamazepine (10-Methoxy-5H-dibenz[b,f] N N H2


28721-09-7 25mg
0025 azepine-5-carboxamide)
O

H
N
10-Ketoiminodibenzyl (10-Oxo-10,11-dihydro-5H-dibenz[b,f]
MM0076.14 21737-58-6 100mg
azepine)
O

H
N
MM0076.14- 10-Ketoiminodibenzyl (10-Oxo-10,11-dihydro-5H-dibenz[b,f]
21737-58-6 25mg
0025 azepine)
O

MM0076.15- 10-Methoxyiminostilbene (10-Methoxy-5H-dibenzo[b,f] NH


4698-11-7 25mg
0025 azepine)
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-104
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N N H2
MM0076.17 Oxcarbazepine 28721-07-5 100mg
O

Carbasalate Calcium
O

O O O
Impurity A (EP): 2-(Acetyloxy)benzoic Anhydride O
MM0133.02 1466-82-6 100mg
(Acetylsalicylic Anhydride) O

O O O
MM0133.02- Impurity A (EP): 2-(Acetyloxy)benzoic Anhydride O
1466-82-6 25mg
0025 (Acetylsalicylic Anhydride) O

OH O
Impurity B (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]benzoic O O
MM0133.01 530-75-6 100mg
Acid (Acetylsalicylsalicylic Acid)
O

OH O
MM0133.01- Impurity B (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]benzoic O O
530-75-6 25mg
0025 Acid (Acetylsalicylsalicylic Acid)
O

O
MM0045.00- OH
Impurity C (EP): Salicylic Acid 69-72-7 250mg
0250
OH

OH
MM0133.03- Impurity D (EP): 2-[(2-Hydroxybenzoyl)oxy]benzoic O OH
552-94-3 250mg
0250 Acid (Salicylsalicylic Acid)
O

Carbendazim
O
H
N O
MM2500.00 Carbendazim 10605-21-7 100mg N
H
N

N NH2

MM2500.01 2,3-Diaminophenazine 655-86-7 100mg


N NH2

N NH2
MM2500.01-
2,3-Diaminophenazine 655-86-7 25mg
0025 N NH2

N NH2

MM2500.02 2-Amino-3-hydroxyphenazine 4569-77-1 100mg


N OH

N NH2
MM2500.02-
2-Amino-3-hydroxyphenazine 4569-77-1 25mg
0025 N OH

H
N
MM2500.03 2-Aminobenzimidazole 934-32-7 100mg NH2
N

H
MM2500.03- N
2-Aminobenzimidazole 934-32-7 25mg NH2
0025 N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-105
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

H
N
MM0474.03 2-Hydroxybenzimidazole 615-16-7 100mg O
N
H

H
N
MM0474.03-
2-Hydroxybenzimidazole 615-16-7 25mg O
0025 N
H

N H2
MM0602.01-
1,2-Phenylenediamine 95-54-5 25mg
0025 N H2

Carbidopa
O

OH
MM1501.00 Carbidopa 38821-49-7 250mg HO
HN
N H2
H2 O

OH

Impurity A (EP) as Sesquihydrate: (2S)-2-Amino-3-(3,4- O

OH
N H2 H2O
MM0643.00 dihydroxyphenyl)-2-methylpropanoic Acid Sesquihydrate (L- 41372-08-1 250mg HO 3

OH
2

Methyldopa Sesquihydrate; Methyldopa Sesquihydrate)


Impurity B (EP) as Hydrochloride: Methyl (2S)-2-Amino-3- O

MM1501.22- O
(3,4-dihydroxyphenyl)-2-methylpropanoate Hydrochloride 115054-62-1 25mg H 2N HCl
HO
0025 OH
(Methyldopa Methyl Ester Hydrochloride)
Impurity C (EP) as Racemate: (RS)-2-Hydrazino-3-(4- O

hydroxy-3-methoxyphenyl)-2-methylpropanoic Acid ((RS)-3- OH


MM1501.09 85933-19-3 100mg HN
HO NH2
O-Methylcarbidopa) O
Related compound A (USP): 3-O-Methylcarbidopa
Impurity C (EP) as Racemate: (RS)-2-Hydrazino-3-(4- O

MM1501.09- hydroxy-3-methoxyphenyl)-2-methylpropanoic Acid ((RS)-3- OH


85933-19-3 25mg HN
HO NH2
0025 O-Methylcarbidopa) O
Related compound A (USP): 3-O-Methylcarbidopa
O

Impurity E (EP): Methyl (2S)-3-(3,4-Dihydroxyphenyl)-2- O


MM1501.04 52514-63-3 100mg HN
hydrazino-2-methylpropanoate (Carbidopa Methyl Ester) HO N H2
OH

MM1501.04- Impurity E (EP): Methyl (2S)-3-(3,4-Dihydroxyphenyl)-2- O


52514-63-3 25mg HN
0025 hydrazino-2-methylpropanoate (Carbidopa Methyl Ester) HO N H2
OH

Impurity F (EP): Ethyl (2S)-3-(3,4-Dihydroxyphenyl)-2- O


MM1501.05 1458640-32-8 100mg HN
HO N H2
hydrazino-2-methylpropanoate (Carbidopa Ethyl Ester) OH

MM1501.05- Impurity F (EP): Ethyl (2S)-3-(3,4-Dihydroxyphenyl)-2- O


1458640-32-8 25mg HN
HO N H2
0025 hydrazino-2-methylpropanoate (Carbidopa Ethyl Ester) OH

O
MM0262.01 Impurity G (EP): 1-(3,4-Dihydroxyphenyl)propan-2-one 2503-44-8 50mg HO
OH

O
MM1501.12- (2RS)-3-(3,4-Dihydroxyphenyl)-2-hydrazino-2- HO
OH
302-53-4 25mg NH
0025 methylpropanoic Acid (rac-Carbidopa) HO H 2N

MM1501.14- O
1-(3,4-Dimethoxyphenyl)propan-2-one 776-99-8 100mg O
0100 O

Carbimazole

N N O
MM1748.00 Carbimazole 22232-54-8 250mg
S O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-106
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Carbinoxamine Maleate
Cl
O

MM1135.00- O
N OH
Carbinoxamine Maleate 3505-38-2 250mg OH
N
0250 O

Cl

O +
N
MM1135.01 Carbinoxamine N-Oxide 1256285-70-7 100mg O
N

Cl

2-(4-Chlorobenzoyl)pyridine O
MM1135.02-
Related compound A (USP): (4-Chlorophenyl)(pyridin-2-yl) 6318-51-0 25mg
0025 N
methanone

Cl

4-Chlorophenyl-2-pyridinylmethanol OH
MM1135.03-
Related compound B (USP): (4-Chlorophenyl)(pyridin-2-yl) 27652-89-7 25mg
0025 N
methanol

N,N-Dimethyl-2-[(RS)-1-phenyl(pyridin-2-yl)methoxy]
ethanamine Hydrogen Fumarate (Deschlorocarbinoxamine O

OH

MM0101.03 Hydrogen Fumarate) n/a 50mg N N HO


O
O

Related compound C (USP): N,N-Dimethyl-2-[phenyl(pyridin-


2-yl)methoxy]ethan-1-amine

Carbocisteine
O
HO
MM0236.00 Carbocisteine 638-23-3 500mg S OH
O NH2

O
(S)-Carboxymethyl-L-cysteine HO
S OH
MM0236.01
(R/S)-Sulphoxide
5439-87-2 100mg
O O NH2

O
MM0236.01- (S)-Carboxymethyl-L-cysteine HO
S OH
5439-87-2 25mg
0025 (R/S)-Sulphoxide O O NH2

NH
MM0236.02 Lactam of (S)-Carboxymethyl-L-cysteine 62305-89-9 100mg S OH

MM0236.02- NH
Lactam of (S)-Carboxymethyl-L-cysteine 62305-89-9 25mg S OH
0025
O

O
HO
MM0236.03 L-Cysteinesulfinic Acid 1115-65-7 100mg S OH
O NH2

O
MM0236.03- HO
L-Cysteinesulfinic Acid 1115-65-7 25mg S OH
0025 O NH2

MM0236.04- NH
Lactam of (S)-Carboxymethyl-(D,L)-cysteine 14226-97-2 25mg S OH
0025
O

O
O
S O
MM0236.09 Carbocisteine Diisopropyl Ester 792135-12-7 100mg O N H2

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-107
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HCl
O
MM0236.13- O
Carbocisteine Diethyl Ester Hydrochloride 92282-33-2 25mg S O

0025 O N H2

O
O
S OH HCl
MM0236.14 S-[2-(1-Methylethoxy)-2-oxoethyl]-L-cysteine Hydrochloride n/a 100mg O NH2

O
MM0236.14- O
S OH HCl
S-[2-(1-Methylethoxy)-2-oxoethyl]-L-cysteine Hydrochloride n/a 25mg O NH2
0025
O

MM0236.19- (3R)-5-Oxothiomorpholine-3-carboxamide (Lactam of S- NH


n/a 25mg S N H2
0025 Carboxymethyl-L-cysteinamide)
O

O
MM0236.20- O
S O
68114-23-8 25mg HCl
Carbocisteine Diisopropyl Ester Hydrochloride O N H2
0025

Carboplatin
O

MM1519.01- OH
Impurity B (EP): Cyclobutane-1,1-dicarboxylic Acid 5445-51-2 25mg OH
0025
O

O
MM1519.02-
Cyclobutanecarboxylic Acid 3721-95-7 100mg OH
0100

Carbromal
O O
Br
MM1686.00 Carbromal 77-65-6 250mg H2 N N
H

Carbutamide
O O O
S
MM1856.00 Carbutamide 339-43-5 100mg N
H
N
H
H 2N

Cariprazine Hydrochloride
AND Enantiomer

MM3927.00- N Cl
N Cl
Cariprazine 839712-12-8 250mg O

N N
0250 H

Carisoprodol
O O

MM0782.00 Carisoprodol 78-44-4 250mg N


H
O O NH2

Impurity A (EP): (2RS)-2-(Hydroxymethyl)-2- N O OH


MM0782.01 25462-17-3 50mg H
methylpentyl (1-Methylethyl)carbamate

O O
MM0782.02 Impurity B (EP): 5-Methyl-5-propyl-1,3-dioxan-2-one 7148-50-7 100mg

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-108
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HO OH
MM0782.03 Impurity C (EP): 2-Methyl-2-propylpropane-1,3-diol 78-26-2 100mg

MM0782.03- HO OH
Impurity C (EP): 2-Methyl-2-propylpropane-1,3-diol 78-26-2 25mg
0025

Carmustine
O
MM0923.01- Impurity A (EP): 1,3-Bis(2-chloroethyl)urea Cl Cl
2214-72-4 25mg N N
0025 Related compound A (USP): 1,3-bis(2-chloroethyl)urea H H

Carprofen
H
N OH
MM1484.00-
Carprofen 53716-49-7 250mg O

0250
Cl

H
N O
MM1484.02- Impurity G (EP): Ethyl (2RS)-2-(6-Chloro-9H-carbazol-2-yl) O
52262-89-2 25mg
0025 propanoate (Carprofen Ethyl Ester)
Cl

H
N
Carbazole
Related compound A (USP): carbazole
MM1484.01 86-74-8 100mg

H
N
MM1484.01- Carbazole
Related compound A (USP): carbazole
86-74-8 25mg
0025

H
N O
MM1484.03- O
Carprofen Methyl Ester 52263-88-4 25mg
0025
Cl

H
N O
MM1484.04- O
Carprofen Isopropyl Ester n/a 25mg
0025 Cl

H
N O

O OH

MM1484.05- Carprofen 1,3-Butylene Glycol Esters (Mixture of Regio- and Cl

n/a 25mg H
O OH
0025 Stereoisomers) N

Cl

OH
H
N O
MM1484.06- O
Carprofen 2,3-Butylene Glycol Ester n/a 25mg
0025 Cl

OH
H
N O H
MM1484.07- Carprofen 1,2-Propylene Glycol Esters (Mixture of Regio- and O
N

O
O
OH

n/a 25mg Cl
Cl
0025 Stereoisomers)
OH
H
N O OH

MM1484.08- Carprofen 1,2,3-Propanetriol Esters (Mixture of Regio- and O H


N O
OH
n/a 25mg Cl
O
OH

0025 Stereoisomers) Cl

Carvedilol
OH
H
O N
MM0291.00- O

Carvedilol 72956-09-3 250mg O

0250 N
H

Impurity A (EP): 1-[[9-[2-Hydroxy-3-[[2-(2-methoxy-


phenoxy)ethyl]amino]propyl]-9H-carbazol-4-
MM0291.01- yl]oxy]-3-[[2-(2-methoxyphenoxy)ethyl]amino]- O

O
OH
H

propan-2-ol
O N
O
1198090-73-1 25mg N
O

0025 Related compound A (USP): 1-(4-(2-hydroxy-3-(2-(2- H

HO
N

methoxyphenoxy)ethylamino)propoxy)-9H-carbazol-9-yl)-3-(2-
(2-methoxyphenoxy)ethylamino)propan-2-ol

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-109
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity B (EP): 1,1'-[[2-(2-Methoxyphenoxy)ethyl]- OH

MM0291.02- nitrilo]bis[3-(9H-carbazol-4-yloxy)propan-2-ol] O
OH
N
O NH

Related compound B (USP): 3,3'-(2-(2-methoxyphenoxy)


918903-20-5 25mg O
0025 N

ethylazanediyl)bis(1-(9H-carbazol-4-yloxy)propan-2-ol) H

Impurity C (EP): (2RS)-1-[Benzyl[2-(2-methoxy-


MM0291.03- phenoxy)ethyl]amino]-3-(9H-carbazol-4- OH
O N
yloxy)propan-2-ol 72955-94-3 25mg O
O
0025 Related compound C (USP): 1-(9H-Carbazol-4-yloxy)-3- N
H

(benzyl(2-(2-methoxyphenoxy)ethyl)amino)propan-2-ol
Impurity D (EP): 1-(9H-Carbazol-4-yloxy)-3-[4-[2-hydroxy-3- O
OH
H
N
O
O

MM0291.13 [[2-(2-methoxyphenoxy)ethyl]amino]propoxy]-9H-carbazol-9- 1391052-16-6 100mg HN


O
HO
N

yl]propan-2-ol

MM0291.13- Impurity D (EP): 1-(9H-Carbazol-4-yloxy)-3-[4-[2-hydroxy-3- O


OH
H
N
O
O

[[2-(2-methoxyphenoxy)ethyl]amino]propoxy]-9H-carbazol-9- 1391052-16-6 25mg HN


O
HO
N

0025 yl]propan-2-ol

MM0291.04 Toluene 108-88-3 100mg

H 2N

MM0291.09- 2-(2-Methoxyphenoxy)ethylamine O
O
Related compound E (USP): 2-(2-Methoxyphenoxy)ethyl 1836-62-0 25mg
0025 amine hydrochloride monohydrate
O
O
MM0291.10- 4-(2,3-Epoxypropoxy)carbazole
Related compound D (USP): 4-(Oxiran-2-ylmethoxy)-9H- 51997-51-4 25mg
0025 carbazole N
H

2-(2-Methoxyphenoxy)ethylamine H 2N
O
Hydrochloride O HCl

Related compound E (USP): 2-(2-Methoxyphenoxy)ethyl


MM0291.11 64464-07-9 100mg
amine hydrochloride monohydrate
2-(2-Methoxyphenoxy)ethylamine H 2N
O
MM0291.11- Hydrochloride O HCl

0025 Related compound E (USP): 2-(2-Methoxyphenoxy)ethyl 64464-07-9 25mg


amine hydrochloride monohydrate
OH

MM0291.12-
4-Hydroxycarbazole 52602-39-8 25mg
0025
N
H

OH
O OH
MM0291.14-
3-(9H-Carbazol-4-yloxy)propane-1,2-diol 123119-89-1 25mg
0025 N
H

OH
O N
MM0291.17- 1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl](1- O
O
1246819-01-1 25mg
0025 methylethyl)amino]propan-2-ol (N-Isopropylcarvedilol) N
H

OH OH
O N
MM0291.21- 1-(9H-Carbazol-4-yloxy)-3-[hydroxy[2-(2-methoxyphenoxy) O
O
1059573-38-4 25mg
N
0025 ethyl]amino]-2-propanol (N-Hydroxycarvedilol) H

O
OH
O N
MM0291.22- O
O
N-Formylcarvedilol n/a 25mg
0025 N
H

Castor Oil, Hydrogenated


O

MM3599.01 Methyl 12-Hydroxystearate 141-23-1 100mg OH


O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-110
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cefaclor
O OH

O Cl

Cefaclor Monohydrate NH2 N H2 O


H
MM0326.00 70356-03-5 100mg N
S
H
O

NH2
Impurity A (EP): (2R)-2-Amino-2-phenylacetic OH
MM0253.12 875-74-1 100mg
Acid (D-Phenylglycine) O

NH2
MM0253.12- Impurity A (EP): (2R)-2-Amino-2-phenylacetic OH
875-74-1 25mg
0025 Acid (D-Phenylglycine) O

Impurity D (EP): (2R,6R,7R)- and (2S,6R,7R)-7-[[(2R)-2- O OH

O
Amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia- NH2
H
N
Cl

MM0326.03 152575-13-8 100mg N


1-azabicyclo[4.2.0]oct-3-ene-2-carboxylic Acid O
H
S

(delta-3-Cefaclor)
Impurity D (EP): (2R,6R,7R)- and (2S,6R,7R)-7-[[(2R)-2- O OH

O
MM0326.03- Amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia- NH2
H
N
Cl

152575-13-8 25mg N
0025 1-azabicyclo[4.2.0]oct-3-ene-2-carboxylic Acid O
H
S

(delta-3-Cefaclor)
HO N

MM0253.08 Impurity F (EP): 3-Phenylpyrazin-2-ol 73200-73-4 100mg N

HO N

MM0253.08-
Impurity F (EP): 3-Phenylpyrazin-2-ol 73200-73-4 25mg N
0025

Cefadroxil Monohydrate
O OH
H 2O
O
N H2 N
MM0972.00 Cefadroxil Monohydrate 66592-87-8 250mg H
N
S
H
O
HO

NH2

Impurity A (EP): (2R)-2-Amino-2-(4-hydroxyphenyl)- OH


MM0232.09 22818-40-2 100mg
acetic Acid HO
O

NH2
MM0232.09- Impurity A (EP): (2R)-2-Amino-2-(4-hydroxyphenyl)- OH
22818-40-2 25mg
0025 acetic Acid HO
O

Impurity B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo- O OH


5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic
O
Acid (7-ADCA; 7-Aminodesacetoxycephalosporanic N
MM0811.01
Acid)
22252-43-3 100mg
Related compound B (USP): (6R,7R)-7-amino-3-methyl-8- H 2N
H
S

oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
Impurity B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo- O OH
5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic
O
MM0811.01- Acid (7-ADCA; 7-Aminodesacetoxycephalosporanic N
Acid)
22252-43-3 25mg
0025
Related compound B (USP): (6R,7R)-7-amino-3-methyl-8- H 2N
H
S

oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

Cefalexin Monohydrate (Cephalexin)


O OH
H2 O
O
N H2 N
MM0605.00 Cefalexin Monohydrate 23325-78-2 500mg H
N
S
H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-111
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

NH2
Impurity A (EP): (2R)-2-Amino-2-phenylacetic OH
MM0253.12 875-74-1 100mg
Acid (D-Phenylglycine) O

NH2
MM0253.12- Impurity A (EP): (2R)-2-Amino-2-phenylacetic OH
875-74-1 25mg
0025 Acid (D-Phenylglycine) O

O OH
Impurity B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-
O
5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic N
MM0811.01 22252-43-3 100mg
Acid (7-Aminodesacetoxycephalosporanic Acid;
S
7-ADCA) H 2N
H

O OH
Impurity B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-
O
MM0811.01- 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic N
22252-43-3 25mg
0025 Acid (7-Aminodesacetoxycephalosporanic Acid;
S
7-ADCA) H 2N
H

O
MM0605.11- HCl
Methyl (2R)-2-Amino-2-phenylacetate Hydrochloride 19883-41-1 25mg O
0025 N H2

O OH
O
(6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo-5-thia-1- O
N O
MM0238.08 957-68-6 100mg
azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA) H 2N S
H

O OH
O
MM0238.08- (6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo-5-thia-1- O
N O
957-68-6 25mg
0025 azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA) H 2N S
H

HO N

MM0253.08 3-Phenylpyrazin-2-ol 73200-73-4 100mg N

HO N

MM0253.08-
3-Phenylpyrazin-2-ol 73200-73-4 25mg N
0025

Cefalonium Dihydrate
H2 O O O
2
O

MM3169.00 Cefalonium Dihydrate 1385046-35-4 250mg S


O

N
N

S
N
+

NH2
H H
O

Cefazolin Sodium
+
O O Na

O
N
N O N S
MM0238.00 Cefazolin Sodium 27164-46-1 100mg N
N
N S S N
H H
N

S
Impurity E (EP): 5-Methyl-1,3,4-thiadiazol-2-thiol SH
MM0238.05 29490-19-5 100mg
(MMTD) N N

S
MM0238.05- Impurity E (EP): 5-Methyl-1,3,4-thiadiazol-2-thiol SH
29490-19-5 25mg
0025 (MMTD) N N

O OH
Impurity H (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7- O
O

MM0238.08 amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2- 957-68-6 100mg N O

ene-2-carboxylic Acid (7-ACA) H 2N


H
S

O OH

MM0238.08- Impurity H (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7- O


O

amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2- 957-68-6 25mg N O

0025 ene-2-carboxylic Acid (7-ACA) H 2N


H
S

N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-112
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cefdinir
O OH

O
S O N
MM1042.00 Cefdinir 91832-40-5 250mg H 2N
N N S
H H
N
OH

Cefepime Dihydrochloride Monohydrate


O O
HCl
2 O
O

Cefepime Dihydrochloride Monohydrate


+
H2O N N N
H
MM1475.00 123171-59-5 250mg H2 N
N N
S
H H
S O

O
Impurity D (EP): (2Z)-(2-Aminothiazol-4-yl)(methoxyimino) N
MM1475.01 65872-41-5 100mg N OH
acetic Acid H 2N
S O

O
MM1475.01- Impurity D (EP): (2Z)-(2-Aminothiazol-4-yl)(methoxyimino) N
65872-41-5 25mg N OH
0025 acetic Acid H 2N
S O

Cefetamet
O OH

O
MM0811.01 7-Aminodesacetoxycephalosporanic Acid 22252-43-3 100mg N

H 2N S
H

O OH

O
MM0811.01-
7-Aminodesacetoxycephalosporanic Acid 22252-43-3 25mg N
0025
H 2N S
H

Cefixime Trihydrate
O
O OH
H2 O OH
O
Cefixime Trihydrate
3 O
N N
MM0316.00 125110-14-7 250mg H
N N
H2 N S
H
S O

Cefoperazone Sodium
SH

MM0853.03 Impurity C (EP): 1-Methyl-1H-tetrazole-5-thiol 13183-79-4 100mg N N


N N

SH
MM0853.03-
Impurity C (EP): 1-Methyl-1H-tetrazole-5-thiol 13183-79-4 25mg N N
0025
N N
O OH
Impurity E (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7- O
O

MM0238.08 amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2- 957-68-6 100mg N O

ene-2-carboxylic Acid (7-ACA) H 2N


H
S

O OH

MM0238.08- Impurity E (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7- O


O

amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2- 957-68-6 25mg N O

0025 ene-2-carboxylic Acid (7-ACA) H 2N


H
S

N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-113
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cefotaxime Sodium
+
O O Na
O
O O

MM0414.00 Cefotaxime Sodium 64485-93-4 250mg H2 N


N
N
H
N
N

S
O

H
S O

O
N
MM1475.01 (2Z)-(2-Aminothiazol-4-yl)(methoxyimino)acetic Acid 65872-41-5 100mg N OH
H 2N
S O

O
MM1475.01- N
(2Z)-(2-Aminothiazol-4-yl)(methoxyimino)acetic Acid 65872-41-5 25mg N OH
0025 H 2N
S O

O OH
O
(6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo-5-thia-1- O
N O
MM0238.08 957-68-6 100mg
azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA) H 2N S
H

O OH
O
MM0238.08- (6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo-5-thia-1- O
N O
957-68-6 25mg
0025 azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA) H 2N S
H

O
MM0251.04- S-Benzothiazol-2-yl (2Z)-(2-aminothiazol-4-yl)(methoxyimino) N N
80756-85-0 25mg N S
H2 N S
0025 thioacetate S O

Cefotetan Disodium
N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20

Cefoxitin Sodium
+
O O Na
O
O

MM1858.00 Cefoxitin Sodium 33564-30-6 250mg S


H
N
N

S
O NH2

O H
O

Cefradine
O OH

O
NH2 N
MM0833.00 Cefradine 38821-53-3 250mg H
N
S
H
O

O OH
Impurity A (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-
O
5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic N
MM0811.01 22252-43-3 100mg
Acid (7-Aminodeacetoxycephalosporanic Acid,
S
7-ADCA) H 2N
H

O OH
Impurity A (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-
O
MM0811.01- 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic N
22252-43-3 25mg
0025 Acid (7-Aminodeacetoxycephalosporanic Acid,
S
7-ADCA) H 2N
H

Ceftiofur
O OH
O
O O

MM3577.00 Ceftiofur 80370-57-6 250mg H2 N


N
N
H
N
N

H
S
S
O

S O

Ceftriaxone Sodium
O
+ +
O O Na O Na
N

MM0251.00 Ceftriaxone Sodium Hemiheptahydrate 104376-79-6 250mg H2 N


N
N
O

O
O

H
N
N

H
S
S N
N H2O
7

S
2

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-114
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
O
MM0251.03- Impurity C (EP): 2-Methyl-3-sulfanyl-1,2-dihydro-1,2,4- N
58909-39-0 25mg
0025 triazine-5,6-dione NH
HS N

MM0251.04- Impurity D (EP): S-Benzothiazol-2-yl (2Z)-(2-Aminothiazol-4- N


O

S
N
80756-85-0 25mg N

0025 yl)(methoxyimino)thioacetate H2 N
S O
S

Cefuroxime Axetil
O OH
O
O O

MM1341.10 Impurity D (EP): Cefuroxime 55268-75-2 100mg O


N
H
N
N

S
O NH2

H
O

Impurity E (EP): (5aR,6R)-6-[[(2Z)-2-(Furan-2-yl)-2- O


O

O O
MM1341.08- (methoxyimino)acetyl]amino]-5a,6-dihydro-3H,7H-azeto[2,1- N N
947723-87-7 25mg H
O N
0025 b]furo[3,4-d][1,3]thiazine-1,7(4H)-dione S
H
O
(Descarbamoylcefuroxime Lactone)

Cefuroxime Sodium
+
O O Na
O
O O

MM1341.00 Cefuroxime Sodium 56238-63-2 250mg O


N
H
N
N

S
O NH2

H
O

O OH
O
O O
N N O NH2
H
MM1341.10 Cefuroxime 55268-75-2 100mg O N
S
H
O

O
MM1341.11- O OH
2-(Furan-2-yl)-2-oxoacetic Acid 1467-70-5 25mg
0025
O

Celecoxib

O O
S
N H2

MM0344.00 Celecoxib 169590-42-5 100mg N


N
F
F
F

O O
Impurity A (EP): 4-[5-(3-Methylphenyl)-3-(trifluoromethyl)-1H- S
N H2

MM0344.06 pyrazol-1-yl]benzenesulfonamide 170570-01-1 50mg N


Related compound A (USP): 4-[5-(3-methylphenyl)-3- N
F
(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide F
F

Impurity B (EP): 4-[3-(4-Methylphenyl)-5-(trifluoromethyl)-1H-


MM0344.07- pyrazol-1-yl]benzenesulfonamide N
331943-04-5 25mg
0025 Related compound B (USP): 4-[3-(4-methylphenyl)-5- N

F
(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide F F S
NH2

O O

HO

O O
4-[5-[4-(Hydroxymethyl)phenyl]-3- S
NH2
MM0344.02 (trifluoromethyl)-1H-pyrazol-1-yl]- 170571-00-3 100mg N

benzenesulfonamide F
N

F
F

HO

O O

MM0344.02- 4-[5-[4-(Hydroxymethyl)phenyl]-3- S
NH2
(trifluoromethyl)-1H-pyrazol-1-yl]- 170571-00-3 25mg N
0025 benzenesulfonamide F
N

F
F

O
HO

4-[1-[4-(Aminosulfonyl)phenyl]-3- O O
S
N H2
MM0344.03 (trifluoromethyl)-1H-pyrazol-5- 170571-01-4 100mg N
yl]benzoic Acid N
F
F
F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-115
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
HO

4-[1-[4-(Aminosulfonyl)phenyl]-3- O O
S
MM0344.03- N H2
(trifluoromethyl)-1H-pyrazol-5- 170571-01-4 25mg N
0025 yl]benzoic Acid N
F
F
F

O O
S
MM0344.08- NH2
HCl
[4-(Aminosulfonyl)phenyl]hydrazine Hydrochloride 17852-52-7 25mg HN
0025
NH2

MM0344.09 4'-Methylacetophenone 122-00-9 100mg

MM0344.10-
1-(4-Methylphenyl)-4,4,4-trifluorobutane-1,3-dione 720-94-5 25mg
0025 O
F
F O
F

MM0344.11-
3-(4-Methylphenyl)-5-(trifluoromethyl)-1H-pyrazole 219986-64-8 25mg
0025 N
NH
F
F
F

O
MM0344.12- O
Methyl 4-Methylbenzoate 99-75-2 100mg
0100

O O
S
N H2
MM0344.19- 4-[5-(2-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]
170569-99-0 25mg N

0025 benzenesulfonamide N
F
F
F

Celiprolol Hydrochloride
O
OH
H
MM0128.00- O N

Celiprolol Hydrochloride 57470-78-7 250mg N


O

N
H
HCl

0250
Impurity A (EP): 1-[5-Amino-2-[(2RS)-3-[(1,1- O
OH
H
O N
MM0128.01 dimethylethyl)amino]-2-hydroxypropoxy]- 56980-94-0 100mg
phenyl]ethanone H 2N

MM0128.01- Impurity A (EP): 1-[5-Amino-2-[(2RS)-3-[(1,1- O


OH
H
O N
dimethylethyl)amino]-2-hydroxypropoxy]- 56980-94-0 25mg
0025 phenyl]ethanone H 2N

Impurity C (EP): 1-[3-Acetyl-4-[(2RS)-3-[(1,1- O


OH
H
O N

MM0128.03 dimethylethyl)amino]-2-hydroxypropoxy]- 57471-01-9 100mg N


O

phenyl]-3-(1,1-dimethylethyl)urea H H

MM0128.03- Impurity C (EP): 1-[3-Acetyl-4-[(2RS)-3-[(1,1- O


OH
H
O N

dimethylethyl)amino]-2-hydroxypropoxy]- 57471-01-9 25mg N


O

N
0025 phenyl]-3-(1,1-dimethylethyl)urea H H

Impurity D (EP): 3-[3-Acetyl-4-[(2RS)-3- O

O
OH
N
O

MM0128.10 (diethylamino)-2-hydroxypropoxy]phenyl]- n/a 100mg N N


H

1,1-diethylurea

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-116
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0128.10- Impurity D (EP): 3-[3-Acetyl-4-[(2RS)-3- O

O
OH
N
O

(diethylamino)-2-hydroxypropoxy]phenyl]- n/a 25mg N N


H
0025 1,1-diethylurea
Impurity E (EP): 1,1'-[[(1,1-Dimethyl- O
OH OH
O

MM0128.05- ethyl)imino]bis[(2-hydroxypropane- HN
O N O

NH
n/a 25mg
0025 1,3-diyl)oxy(3-acetyl-1,4-phenylene)]]- O N N O

bis(3,3-diethylurea)
O

Impurity F (EP): 3-(3-Acetyl-4-hydroxyphenyl)- O


OH

MM0128.07 79881-89-3 100mg


1,1-diethylurea N N
H

MM0128.07- Impurity F (EP): 3-(3-Acetyl-4-hydroxyphenyl)- O


OH

79881-89-3 25mg
0025 1,1-diethylurea N N
H

O
O
Impurity G (EP): 3-[3-Acetyl-4-[[(RS)-oxiranyl]- O
O

MM0128.06 56980-98-4 100mg


methoxy]phenyl]-1,1-diethylurea N N
H

O
O
MM0128.06- Impurity G (EP): 3-[3-Acetyl-4-[[(RS)-oxiranyl]- O
O

56980-98-4 25mg
0025 methoxy]phenyl]-1,1-diethylurea N N
H

Impurity H (EP): 3-[3-Acetyl-4-[(2RS)-3-bromo- O

O
OH
Br
O
MM0128.04 2-hydroxypropoxy]phenyl]-1,1-diethylurea 85045-98-3 100mg N N
H
(Bromhydrin Compound)

MM0128.04- Impurity H (EP): 3-[3-Acetyl-4-[(2RS)-3-bromo- O

O
OH
Br
O
2-hydroxypropoxy]phenyl]-1,1-diethylurea 85045-98-3 25mg N N
H
0025 (Bromhydrin Compound)
O

MM0128.11- OH HCl
3-Acetyl-4-hydroxyaniline Hydrochloride 57471-32-6 25mg
0025 H2 N

MM0128.58- OH
5-Acetamido-2-hydroxyacetophenone 7298-67-1 25mg O
0025
N
H

Cephalexin, see Cefalexin Monohydrate

Cethexonium Bromide
AND Enantiomer

rac-trans-2-Dimethylaminocyclohexanol N
MM0501.01 40571-56-0 100mg OH
Hydrochloride HCl

AND Enantiomer
MM0501.01- rac-trans-2-Dimethylaminocyclohexanol N
40571-56-0 25mg OH
0025 Hydrochloride HCl

Cetirizine Dihydrochloride
O
Cl O
N OH
MM0380.00-
Cetirizine Dihydrochloride
N

83881-52-1 250mg HCl


0250 2

Cl
NH
N
Impurity A (EP): (RS)-1-[(4-Chlorophenyl)-
MM0380.01 303-26-4 100mg
phenylmethyl]piperazine

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-117
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cl
NH
N
MM0380.01- Impurity A (EP): (RS)-1-[(4-Chlorophenyl)-
303-26-4 25mg
0025 phenylmethyl]piperazine

Impurity B (EP) as Dihydrochloride: (RS)- Cl


N
OH

2-[4-[(4-Chlorophenyl)phenylmethyl]- N O

MM0380.02 n/a 100mg


piperazin-1-yl]acetic Acid HCl
2

Dihydrochloride
Impurity B (EP) as Dihydrochloride: (RS)- Cl
N
OH

MM0380.02- 2-[4-[(4-Chlorophenyl)phenylmethyl]- N O

n/a 25mg
0025 piperazin-1-yl]acetic Acid HCl
2

Dihydrochloride
Impurity C (EP) as Dihydrochloride: (RS)- O
O

N OH
2-[2-[4-[(2-Chlorophenyl)phenylmethyl]- N
MM0380.03 n/a 100mg
piperazin-1-yl]ethoxy]acetic Acid Cl HCl
2

Dihydrochloride
Impurity C (EP) as Dihydrochloride: (RS)- O
O

N OH
MM0380.03- 2-[2-[4-[(2-Chlorophenyl)phenylmethyl]- N
n/a 25mg
0025 piperazin-1-yl]ethoxy]acetic Acid Cl HCl
2

Dihydrochloride

Impurity D (EP): 1,4-Bis[(4-chlorophenyl)- N


Cl

MM0380.04 346451-15-8 100mg N

phenylmethyl]piperazine Cl

MM0380.04- Impurity D (EP): 1,4-Bis[(4-chlorophenyl)- N


Cl

346451-15-8 25mg N

0025 phenylmethyl]piperazine Cl

Impurity E (EP) as Dihydrochloride: (RS)-


2-[2-[2-[4-[(4-Chlorophenyl)phenyl- Cl

N
N
O
O
O
OH

MM0380.05 methyl]piperazin-1-yl]ethoxy]ethoxy]- 83881-56-5 100mg HCl


2

acetic Acid Dihydrochloride


(Ethoxycetirizine Dihydrochloride)
Impurity E (EP) as Dihydrochloride: (RS)-
MM0380.05- 2-[2-[2-[4-[(4-Chlorophenyl)phenyl- Cl

N
N
O
O
O
OH

methyl]piperazin-1-yl]ethoxy]ethoxy]- 83881-56-5 25mg HCl


2

0025 acetic Acid Dihydrochloride


(Ethoxycetirizine Dihydrochloride)
Impurity F (EP) as Dihydrochloride: [2-[4- N
O
O

OH
N

MM0380.06 (Diphenylmethyl)piperazin-1- 83881-54-3 100mg HCl


2

yl]ethoxy]acetic Acid Dihydrochloride

MM0380.06- Impurity F (EP) as Dihydrochloride: [2-[4- N


O
O

OH
N

(Diphenylmethyl)piperazin-1- 83881-54-3 25mg HCl


2

0025 yl]ethoxy]acetic Acid Dihydrochloride


Impurity G (EP) as Dihydrochloride: 2-[4-
[(RS)-(4-Chlorophenyl)phenylmethyl]- Cl

N
N
OH

MM0380.11 piperazin-1-yl]ethanol Dihydrochloride 164726-80-1 100mg HCl


2

Related compound G (USP): 2-4-[(4-Chlorophenyl)


phenylmethyl]piperazin-1-ylethanol
Impurity G (EP) as Dihydrochloride: 2-[4-
MM0380.11- [(RS)-(4-Chlorophenyl)phenylmethyl]- Cl

N
N
OH

piperazin-1-yl]ethanol Dihydrochloride 164726-80-1 25mg HCl


2

0025 Related compound G (USP): 2-4-[(4-Chlorophenyl)


phenylmethyl]piperazin-1-ylethanol
O
Cl O
N O

Isopropyl Ester of Cetirizine


N

MM0380.08 324047-27-0 100mg

MM0380.09 4-Chlorobenzhydrol 119-56-2 100mg


OH

Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-118
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0380.09-
4-Chlorobenzhydrol 119-56-2 25mg
0025 OH

Cl

MM0380.10 4-Chlorobenzophenone 134-85-0 100mg


O

Cl

MM0380.10-
4-Chlorobenzophenone 134-85-0 25mg
0025 O

Cl
O
O
Cl + O
N OH
N

MM0380.13 Cetirizine N-Oxide 1076199-80-8 100mg

Ethyl Ester of Cetirizine Dihydrochloride


O
Cl O
N O

MM0380.15 Related compound A (USP): (RS)-2-[2-[4-[(4-Chlorophenyl) n/a 100mg


N

HCl
2

phenylmethyl]piperazin-1-yl]ethoxy]acetic acid ethyl ester


Ethyl Ester of Cetirizine Dihydrochloride
O
Cl O
N O
MM0380.15-
Related compound A (USP): (RS)-2-[2-[4-[(4-Chlorophenyl) n/a 25mg
N

HCl
2
0025 phenylmethyl]piperazin-1-yl]ethoxy]acetic acid ethyl ester
O
Cl O
N O

Methyl Ester of Cetirizine Dihydrochloride


N
HCl
MM0380.16 83881-48-5 100mg 2

O
Cl O
N O
MM0380.16-
Methyl Ester of Cetirizine Dihydrochloride
N
HCl
83881-48-5 25mg 2

0025
3-Chlorocetirizine Dihydrochloride O
O

((RS)-2-[2-[4-[(3-Chlorophenyl)phenyl- Cl
N
N OH

MM0380.17 1232460-29-5 100mg


methyl]piperazin-1-yl]ethoxy]acetic Acid HCl
2

Dihydrochloride)
3-Chlorocetirizine Dihydrochloride O
O

MM0380.17- ((RS)-2-[2-[4-[(3-Chlorophenyl)phenyl- Cl
N
N OH

1232460-29-5 25mg
0025 methyl]piperazin-1-yl]ethoxy]acetic Acid HCl
2

Dihydrochloride)
OH
2-(4-Benzhydrylpiperazin-1-yl)ethan-1-ol Dihydrochloride N

MM0380.20- N
HCl
Related compound B (USP): 2-(4-Benzhydrylpiperazin-1-yl) 108983-83-1 25mg 2

0025
ethan-1-ol
O O
MM0380.23- S
N
1-[(4-Methylphenyl)sulfonyl]piperazine 27106-51-0 25mg
0025 HN

Cetrimide

MM0876.00 Cetrimide 1119-97-7 250mg N


+
Br

Chenodeoxycholic Acid
O

H
OH
MM0836.00- H
Impurity A (EP): Ursodeoxycholic Acid 128-13-2 250mg H H
0250 HO
H
OH

O
OH
H
OH
MM0835.02- Impurity B (EP): 3 ,7 ,12 -Trihydroxy-5 -cholan-24-oic Acid H
81-25-4 250mg H H
0250 (Cholic Acid) HO
H
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-119
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0835.03- Impurity C (EP): 3 -Hydroxy-5 -cholan-24-oic Acid H


H
OH

434-13-9 25mg
0025 (Lithocholic Acid) HO
H H

O
OH
H
OH
MM0835.05- Impurity E (EP): 3 ,12 -Dihydroxy-5 -cholan-24-oic Acid H
83-44-3 250mg H H
0250 (Deoxycholic Acid) HO
H

H
O

MM0835.07 Impurity G (EP): Methyl 3 ,7 -Dihydroxy-5 -cholan-24-oate 10538-55-3 100mg H


H

H
HO OH
H

H
O
MM0835.07-
Impurity G (EP): Methyl 3 ,7 -Dihydroxy-5 -cholan-24-oate 10538-55-3 25mg H
H

H
0025 HO
H
OH

O
OH
H O
MM0835.12- H
Methyl Cholate 1448-36-8 25mg H H
0025 HO
H
OH

Chloral Hydrate
OH
Cl
MM1650.00 Chloral Hydrate 302-17-0 250mg OH
Cl Cl

Chlorambucil
OH

Cl O

MM0821.00 Chlorambucil 305-03-3 500mg N

Cl

Cl O
N
MM0821.08 Chlorambucil Methyl Ester 79481-83-7 100mg
Cl

Cl O
N
MM0821.09 Chlorambucil Ethyl Ester 64977-24-8 100mg
Cl

Cl O
N
MM0821.10 Chlorambucil Isopropyl Ester 77063-20-8 100mg
Cl

Chloramphenicol
O
+
OH N
O O
MM0516.00 Chloramphenicol 56-75-7 500mg Cl
N
H
Cl OH

O
Impurity A (EP): (1R,2R)-2-Amino-1-(4-nitrophenyl)propane- +
OH N
O
MM0516.01 1,3-diol ((D)-(-)-threo-2-Amino-1-(4-nitrophenyl)-1,3- 716-61-0 100mg
H 2N
propanediol)) OH

O
Impurity A (EP): (1R,2R)-2-Amino-1-(4-nitrophenyl)propane- +
OH N
MM0516.01- O
1,3-diol ((D)-(-)-threo-2-Amino-1-(4-nitrophenyl)-1,3- 716-61-0 25mg
0025 H 2N
propanediol)) OH

MM1255.06-
Impurity B (EP): 4-Nitrobenzaldehyde 555-16-8 25mg O
0025 +
N
O

Chlorcyclizine Hydrochloride
Cl
N
N

MM1653.00 Chlorcyclizine Hydrochloride 14362-31-3 100mg HCl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-120
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
Cl +
N
N
MM1653.01 Chlorcyclizine N-Oxide 10457-56-4 100mg

O
Cl +
N
MM1653.01- N
Chlorcyclizine N-Oxide 10457-56-4 25mg
0025

Chlordiazepoxide Hydrochloride
H
N
N

MM0028.00 Chlordiazepoxide Hydrochloride 438-41-5 CS 250mg Cl N


+

O
HCl

H
N
N

MM0028.08- +
Chlordiazepoxide 58-25-3 CS 250mg Cl N
0250 O

H O
Impurity A (EP): 7-Chloro-5-phenyl-1,3-dihydro- N

2H-1,4-benzodiazepin-2-one 4-Oxide +
Cl N
MM0028.02 (Demoxepam) 963-39-3 100mg O
Related compound A (USP): 7-Chloro-1,3-dihydro-5-phenyl-
2H-1,4-benzodiazepin-2-one 4-Oxide
H O
Impurity A (EP): 7-Chloro-5-phenyl-1,3-dihydro- N

2H-1,4-benzodiazepin-2-one 4-Oxide +
MM0028.02- Cl N
(Demoxepam) 963-39-3 25mg O
0025 Related compound A (USP): 7-Chloro-1,3-dihydro-5-phenyl-
2H-1,4-benzodiazepin-2-one 4-Oxide
N
Cl
+
N
Impurity B (EP): 6-Chloro-2-(chloromethyl)-4- Cl O
MM0028.04 5958-24-7 100mg
phenylquinazoline 3-Oxide

N
Cl
+
N
MM0028.04- Impurity B (EP): 6-Chloro-2-(chloromethyl)-4- Cl O
5958-24-7 25mg
0025 phenylquinazoline 3-Oxide

N H2

O
MM0028.03- Impurity C (EP): (2-Amino-5-chlorophenyl)phenyl- Cl
719-59-5 25mg
0025 methanone (Aminochlorobenzophenone)

Chlorhexidine Diacetate
H H H
N N N

MM0162.00- NH NH O

Chlorhexidine Diacetate 56-95-1 250mg


Cl
Cl
NH NH
OH
2

0250 N
H
N
H
N
H

Impurity E (EP) as Hydrochloride: 1-(4-Chlorophenyl) H


MM0162.08- N NH2
HCl
guanidine Hydrochloride ((4-Chlorophenyl)guanidine 14279-91-5 25mg NH
0025 Cl
Hydrochloride)
Cl
O
Impurity F (EP): 1-(4-Chlorophenyl)urea ((4-Chlorophenyl)
MM0162.07 140-38-5 100mg N NH2
urea) H

Cl
MM0162.07- O
Impurity F (EP): 1-(4-Chlorophenyl)urea ((4-Chlorophenyl)
140-38-5 25mg N NH2
0025 urea) H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-121
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cl

MM0162.05 Impurity P (EP): 4-Chloroaniline 106-47-8 100mg


NH2

Cl
MM0162.05-
Impurity P (EP): 4-Chloroaniline 106-47-8 25mg
0025 NH2

H H
N N
N
NH
MM0162.16-
1,1'-(Hexane-1,6-diyl)bis[3-cyanoguanidine] 15894-70-9 25mg
0025 NH
N
N N
H H

Cl
MM0840.06- N-(4-Chlorophenyl)-N -cyanoguanidine NH
N
1482-62-8 25mg N N
0025 H H

MM0162.17- H2 N
NH2 HCl
Hexane-1,6-diamine Dihydrochloride 6055-52-3 25mg 2

0025
Cl
MM0162.23- NH NH
HCl
1-(4-Chlorophenyl)biguanide Hydrochloride 4022-81-5 25mg N
H
N
H
N H2
0025

Chlorhexidine Dihydrochloride
H H H
N N N

NH NH
MM0946.00-
Chlorhexidine Dihydrochloride
Cl
HCl
3697-42-5 250mg Cl 2
NH NH
0250 N
H
N
H
N
H

Chlormadinone Acetate
O

O
H
MM0529.00 Chlormadinone Acetate 302-22-7 100mg H H
O

O
Cl

Impurity D (EP): 6-Chloro-3,20-dioxopregna-1,4,6-trien-17-yl O


H
MM0529.07 Acetate (Delmadinone Acetate; 1,2-Didehydrochlormadinone 13698-49-2 100mg O
H H
O
Acetate) Cl

Impurity D (EP): 6-Chloro-3,20-dioxopregna-1,4,6-trien-17-yl O


MM0529.07- H
Acetate (Delmadinone Acetate; 1,2-Didehydrochlormadinone 13698-49-2 25mg O
H H
0025 O
Acetate) Cl

Impurity G (EP): 3,20-Dioxopregn-4-en-17-yl Acetate O


H
MM0532.09 302-23-8 100mg O
(Hydroxyprogesterone Acetate) H H
O

MM0532.09- Impurity G (EP): 3,20-Dioxopregn-4-en-17-yl Acetate O


H
302-23-8 25mg O
0025 (Hydroxyprogesterone Acetate) H H
O

MM0222.09- OH
H
17 -Hydroxyprogesterone 68-96-2 25mg
0025 H H
O

O O
S
OH H2O
MM0598.02 4-Methylbenzenesulphonic Acid Hydrate 6192-52-5 100mg

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-122
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Chlormezanone
Cl
O O
S
MM0017.00 Chlormezanone 80-77-3 250mg
N

O
MM0017.03 4-Chlorobenzaldehyde 104-88-1 100mg Cl
H

O
MM0017.03-
4-Chlorobenzaldehyde 104-88-1 25mg Cl
0025 H

Chlorobutanol Hemihydrate
OH
Cl H2 O
MM0535.00 Chlorobutanol Hemihydrate 6001-64-5 500mg
Cl Cl
2

Chlorocresol
OH
MM0459.00-
Chlorocresol 59-50-7 250mg
0250 Cl

Chloropyramine Hydrochloride
Cl

MM1894.00 Chloropyramine Hydrochloride 6170-42-9 250mg N N


N
HCl

Cl

MM1894.04- HCl
Chloropyramine N-Oxide Hydrochloride n/a 25mg N N
N
+
0025 O

Cl
1-[(4-Chlorophenyl)methyl]-2,3-dihydroimidazo[1,2-a] N
MM1894.03 63111-28-4 100mg +
pyridinium Chloride N
Cl

Cl
MM1894.03- 1-[(4-Chlorophenyl)methyl]-2,3-dihydroimidazo[1,2-a] N
63111-28-4 25mg +
0025 pyridinium Chloride N
Cl

Chloroquine Phosphate
Cl N
O OH
P
MM1055.00- HO OH
2
Chloroquine Phosphate 50-63-5 250mg HN
N
0250

Chloroquine Sulfate
Cl N

Chloroquine Sulfate Monohydrate


O O
S H2 O
HN HO OH
MM1868.00 6823-83-2 250mg N

Chloroxylenol
OH

MM1997.00 Chloroxylenol 88-04-0 250mg


Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-123
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cl
OH
2-Chloro-3,5-dimethylphenol
MM1997.01 5538-41-0 100mg
Related compound A (USP): 2-chloro-3,5-dimethylphenol

Cl
OH
MM1997.01- 2-Chloro-3,5-dimethylphenol
5538-41-0 25mg
0025 Related compound A (USP): 2-chloro-3,5-dimethylphenol

Chlorphenamine Maleate (Chlorpheniramine Maleate)


Cl

O
MM0090.00-
Chlorphenamine Maleate 113-92-8 250mg N
OH
OH
0250 N
O

Impurity A (EP) as Dihydrochloride: 2-(4- Cl

Chlorophenyl)-4-(dimethylamino)-2- N

HCl
MM0090.03 2575516-39-9 100mg
[2-(dimethylamino)ethyl]butanenitrile N N
2

Dihydrochloride
Impurity A (EP) as Dihydrochloride: 2-(4- Cl

MM0090.03- Chlorophenyl)-4-(dimethylamino)-2- N
HCl
2575516-39-9 25mg
0025 [2-(dimethylamino)ethyl]butanenitrile N N
2

Dihydrochloride
H
Impurity B (EP): N-(Pyridin-2-yl)pyridin-2-amine N N N
MM0090.04 (2,2'-Dipyridylamine) 1202-34-2 100mg
Related compound B (USP): di(pyridin-2-yl)amine
H
Impurity B (EP): N-(Pyridin-2-yl)pyridin-2-amine N N N
MM0090.04-
(2,2'-Dipyridylamine) 1202-34-2 25mg
0025 Related compound B (USP): di(pyridin-2-yl)amine
Impurity C (EP) as Maleate: (3RS)-3-(4-Chloro- Cl

phenyl)-N-methyl-3-(pyridin-2-yl)propan-1- O

OH
MM0090.13 amine Maleate 22630-25-7 100mg N
OH

Related compound C (USP): 3-(4-chlorophenyl)-N-methyl-3- NH


O

(pyridin-2-yl)propan-1-amine
Impurity C (EP) as Maleate: (3RS)-3-(4-Chloro- Cl

MM0090.13- phenyl)-N-methyl-3-(pyridin-2-yl)propan-1- O

OH
amine Maleate 22630-25-7 25mg N
OH
0025 Related compound C (USP): 3-(4-chlorophenyl)-N-methyl-3- NH
O

(pyridin-2-yl)propan-1-amine
Cl

Impurity D (EP) as Maleate: (2RS)-2-(4-Chloro- N


O

OH
MM0090.05 phenyl)-4-(dimethylamino)-2-(pyridin-2- n/a 100mg N
N
OH

yl)butanenitrile Maleate O

Cl

MM0090.05- Impurity D (EP) as Maleate: (2RS)-2-(4-Chloro- N


O

OH

phenyl)-4-(dimethylamino)-2-(pyridin-2- n/a 25mg N


N
OH

0025 yl)butanenitrile Maleate O

Cl

2-(4-Chlorophenyl)-4-dimethylaminobutyronitrile HCl
MM0090.14 854863-55-1 100mg
Hydrochloride N
N

Cl

MM0090.14- 2-(4-Chlorophenyl)-4-dimethylaminobutyronitrile HCl


854863-55-1 25mg
0025 Hydrochloride N
N

Cl
O

OH
MM0090.15 Chlorphenamine N-Oxide Maleate 2575516-38-8 100mg OH
N +
N
O O

Cl
+
N
MM0090.16 1-(4-Chlorophenyl)-2,3-dihydro-1H-indolizin-4-ium Chloride n/a 100mg Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-124
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cl

O
MM1135.02-
2-(4-Chlorobenzoyl)pyridine 6318-51-0 25mg
0025 N

Chlorphenesin Carbamate
OH
O O N H2
MM1996.00 Chlorphenesin Carbamate 886-74-8 50mg O
Cl

MM1996.01- Chlorphenesin 2-Carbamate (3-(4-Chlorophenoxy)-1,2- O N H2

61514-96-3 25mg O OH
0025 propanediol 2-Carbamate)
Cl

Chlorpheniramine Maleate, see Chlorphenamine Maleate

Chlorphenoxamide
Cl
O O

Chlorphenoxamide
Cl
MM1990.00 3576-64-5 100mg O + N
N OH
O

Chlorphenoxamine Hydrochloride

MM1291.00 Chlorphenoxamine Hydrochloride 562-09-4 100mg O


N HCl

Cl

O
+
MM1291.02 Chlorphenoxamine N-Oxide 110203-91-3 100mg N
O

Cl

Chlorpromazine Hydrochloride

N N
MM0420.00 Chlorpromazine Hydrochloride 69-09-0 500mg S

HCl
Cl

Impurity A (EP): 3-(2-Chloro-10H-phenothiazin- N N


MM0420.01 10-yl)-N,N-dimethylpropan-1-amine S-Oxide 969-99-3 100mg O
S

(Chlorpromazine Sulfoxide)
Cl

MM0420.01- Impurity A (EP): 3-(2-Chloro-10H-phenothiazin- N N


10-yl)-N,N-dimethylpropan-1-amine S-Oxide 969-99-3 25mg O
S
0025 (Chlorpromazine Sulfoxide)
Cl

Impurity B (EP) as Dihydrochloride: N-[3-(2-Chloro-


N N N
MM0420.06 10H-phenothiazin-10-yl)propyl]-N,N',N'-trimethyl- n/a 100mg S

propane-1,3-diamine Dihydrochloride Cl
HCl
2

MM0420.06- Impurity B (EP) as Dihydrochloride: N-[3-(2-Chloro-


N N N
10H-phenothiazin-10-yl)propyl]-N,N',N'-trimethyl- n/a 25mg S

0025 propane-1,3-diamine Dihydrochloride Cl


HCl
2

Impurity C (EP) as Hydrochloride: 3-(10H-Phenothiazin-


MM0290.00- N N
10-yl)-N,N-dimethylpropan-1-amine Hydrochloride 53-60-1 250mg S
HCl

0250 (Promazine Hydrochloride)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-125
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity D (EP) as Hydrochloride: 3-(2-Chloro-10H-


phenothiazin-10-yl)-N-methylpropan-1-amine N NH HCl
MM0420.07 3953-65-9 100mg S
Hydrochloride (Desmethylchlorpromazine
Hydrochloride) Cl

Impurity D (EP) as Hydrochloride: 3-(2-Chloro-10H-


MM0420.07- phenothiazin-10-yl)-N-methylpropan-1-amine N NH HCl
3953-65-9 25mg S
0025 Hydrochloride (Desmethylchlorpromazine
Hydrochloride) Cl

NH
MM0420.04 Impurity E (EP): 2-Chloro-10H-phenothiazine 92-39-7 100mg S

Cl

MM0420.04- NH
Impurity E (EP): 2-Chloro-10H-phenothiazine 92-39-7 25mg S
0025
Cl

O
+
MM0420.02- N N OH
Chlorpromazine Sulphoxide N-Oxide Maleate 150111-59-4 25mg O
S
O
OH

0025 Cl
O

+ HCl
Chlorpromazine Sulfone N-Oxide Hydrochloride N N
MM0420.11 109724-46-1 100mg O S O
O
(Chlorpromazine N,S,S-Trioxide Hydrochloride) Cl

+ HCl
MM0420.11- Chlorpromazine Sulfone N-Oxide Hydrochloride N N
109724-46-1 25mg O S O
O
0025 (Chlorpromazine N,S,S-Trioxide Hydrochloride) Cl

MM0420.12- N N
HCl
Chlorpromazine Sulfone Hydrochloride 18683-73-3 25mg O S
O
0025 Cl

+
N N
HCl
MM0420.13 Chlorpromazine N-Oxide Hydrochloride n/a 100mg S O

Cl

Chlorpropamide
O O O
S
MM1635.00 Chlorpropamide 94-20-2 250mg N
H
N
H
Cl

MM1635.01 Impurity B (EP): 1,3-Dipropylurea 623-95-0 100mg N N


H H

O
MM1635.01-
Impurity B (EP): 1,3-Dipropylurea 623-95-0 25mg N N
0025 H H

Chlorprothixene Hydrochloride

N HCl
MM1321.00 Chlorprothixene Hydrochloride 6469-93-8 250mg S

Cl

OH

Impurity A (EP): (RS)-2-Chloro-9-[3-(dimethylamino)- N


MM1321.01 4295-65-2 100mg S
propyl]-9H-thioxanthen-9-ol
Cl

OH
MM1321.01- Impurity A (EP): (RS)-2-Chloro-9-[3-(dimethylamino)- N
4295-65-2 25mg S
0025 propyl]-9H-thioxanthen-9-ol
Cl

Impurity B (EP) as Hydrochloride: N,N-Dimethyl-3-


MM1321.07- N HCl
(9H-thioxanthen-9-ylidene)propan-1-amine Hydro- 4907-84-0 25mg S
0025 chloride

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-126
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity C (EP) as Hydrochloride: (Z)-3-(2-Chloro-9H--


MM1321.08- N
ylidene)-N-methylpropan-1-amine n/a 25mg S
H HCl

0025 Hydrochloride Cl

O
Cl
MM1321.05 Impurity E (EP): 2-Chloro-9H-thioxanthen-9-one 86-39-5 100mg
S

O
MM1321.05- Cl
Impurity E (EP): 2-Chloro-9H-thioxanthen-9-one 86-39-5 25mg
0025 S

Chlorquinaldol
OH
Cl N

MM0390.00 Chlorquinaldol 72-80-0 500mg


Cl

OH
N
MM0390.01 8-Hydroxyquinaldine (8-Hydroxy-2-methylquinoline) 826-81-3 100mg

OH
MM0390.01- N
8-Hydroxyquinaldine (8-Hydroxy-2-methylquinoline) 826-81-3 25mg
0025

Chlortalidone (Chlorthalidone)
H O
O O N
HO
S
MM0297.00 Chlortalidone 77-36-1 250mg H2 N

Cl

Impurity B (EP): 2-(4-Chloro-3-sulfamoylbenzoyl)benzoic O OH


O O O
Acid H 2N
S
MM0297.02
Related compound A (USP): 4'-Chloro-3'-sulfamoyl-2-
5270-74-6 100mg
Cl

benzophenone Carboxylic Acid


Impurity B (EP): 2-(4-Chloro-3-sulfamoylbenzoyl)benzoic O OH
O O O
MM0297.02- Acid H 2N
S

Related compound A (USP): 4'-Chloro-3'-sulfamoyl-2-


5270-74-6 25mg
0025 Cl

benzophenone Carboxylic Acid

Chlortetracycline Hydrochloride
OH O OH O O
OH
N H2

MM0607.00 Chlortetracycline Hydrochloride 64-72-2 500mg H H


OH
Cl H O N HCl

OH O OH O O
OH

Impurity B (EP) as Hydrochloride: H H


NH2

MM0636.00 64-73-3 250mg


Demeclocycline Hydrochloride Cl OH N
OH
HCl

Impurity D (EP) as Hydrochloride: (4R,4aS,5aS,6S,12aS)-4- OH O OH O


OH
O

(Dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11- H H
N H2

MM0452.01 23313-80-6 50mg


dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2- HO N
OH
HCl

carboxamide Hydrochloride (4-Epitetracycline Hydrochloride)


Impurity E (EP) as Hydrochloride: (4R,4aS,5aS,6S,12aS)-7-
OH O OH O O
Chloro-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-1,11- OH
N H2

MM0636.01 dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2- 179471-95-5 50mg H H


OH
HCl
carboxamide Hydrochloride (4-Epidemeclocycline Cl OH N

Hydrochloride; 4-Epidemethylchlortetracycline Hydrochloride)


Impurity J (EP) as Hydrochloride: (4S,4aS,12aS)-4- OH OH O O O
OH
MM0452.03- (Dimethylamino)-3,10,12,12a-tetrahydroxy-6-methyl-1,11- N H2
H
13803-65-1 25mg OH
0025 dioxo-1,4,4a,5,11,12a-hexahydrotetracene-2-carboxamide HCl N

Hydrochloride (Anhydrotetracycline Hydrochloride)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-127
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH O OH O O
OH
N H2

MM0452.00 Tetracycline Hydrochloride 64-75-5 500mg H H


OH
HO N HCl

Chlorthalidone, see Chlortalidone

Chlorzoxazone
O
O
MM0908.00 Chlorzoxazone 95-25-0 250mg N
Cl
H

OH
2-Amino-4-chlorophenol
MM0908.01 95-85-2 100mg
Related compound A (USP): 2-Amino-4-chlorophenol Cl N H2

OH
MM0908.01- 2-Amino-4-chlorophenol
95-85-2 25mg
0025 Related compound A (USP): 2-Amino-4-chlorophenol Cl N H2

Cholecalciferol
HO
MM0249.00- H
Cholecalciferol 67-97-0 250mg H

0250

Impurity B (EP): Cholesta-5,7-dien-3 -ol H

MM0249.02 434-16-2 100mg


(7,8-Didehydrocholesterol; Provitamin D3) HO
H H

MM0249.02- Impurity B (EP): Cholesta-5,7-dien-3 -ol H

434-16-2 25mg
0025 (7,8-Didehydrocholesterol; Provitamin D3) HO
H H

H
MM3002.00 Alfacalcidol 41294-56-8 50mg

HO OH

H
HO

H H2 O
MM1549.00 Calcifediol Monohydrate 63283-36-3 100mg

HO

Cholesterol
H
MM0206.00-
Cholesterol 57-88-5 250mg H
H

H
0250 HO

Cholic Acid
O
OH
H
OH
MM0835.02- H
Cholic Acid 81-25-4 250mg H H
0250 HO
H
OH

O
OH
H
MM3876.01- O
H
Cholic Acid Ethyl Ester 47676-48-2 25mg H H
0025 HO
H
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-128
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Ciclesonide

O
O O
H

MM3608.00 Ciclesonide 126544-47-6 100mg HO


H
O
O

H H
O

Ciclopirox
OH
N O
MM3420.00 Ciclopirox 29342-05-0 250mg

Ciclopirox Olamine
OH
N O

MM0418.00 Ciclopirox Olamine 41621-49-2 250mg H 2N


OH

Impurity A (EP): [(5RS)-3-Cyclohexyl-5-methyl-4,5-dihydro-


1,2-oxazol-5-yl]acetic Acid N
O
O
Related compound A (USP): 3-Cyclohexyl-4,5-dihydro-5-
MM0418.01 1823487-53-1 100mg
OH
methyl-5-isoxazolyl acetic acid
Impurity A (EP): [(5RS)-3-Cyclohexyl-5-methyl-4,5-dihydro-
MM0418.01- 1,2-oxazol-5-yl]acetic Acid N
O
O
Related compound A (USP): 3-Cyclohexyl-4,5-dihydro-5-
1823487-53-1 25mg
0025 OH
methyl-5-isoxazolyl acetic acid

Impurity B (EP): 6-Cyclohexyl-4-methyl-2H-


O O
pyran-2-one
Related compound B (USP): 6-Cyclohexyl-4-methyl-2-
MM0418.02 14818-35-0 100mg
pyrone

Impurity B (EP): 6-Cyclohexyl-4-methyl-2H-


O O
MM0418.02- pyran-2-one
Related compound B (USP): 6-Cyclohexyl-4-methyl-2-
14818-35-0 25mg
0025
pyrone

Impurity C (EP): 6-Cyclohexyl-4-methyl- H


N O
pyridin-2(1H)-one
Related compound C (USP): 6-Cyclohexyl-4-methylpyridin-2
MM0418.03 67587-24-0 50mg
(1H)-one

Ciclosporin (Cyclosporine)
O O
N N
N N
H
O NH O O
O N
O
MM0241.00 Ciclosporin 59865-13-3 250mg N
N
O
N
N
O
NH
H
OH
H
O O

Cidofovir
NH2

MM3558.00 Cidofovir 113852-37-2 100mg O N O OH


O P
OH

OH

Cilastatin Sodium
O O +
Na

Cilastatin Sodium
HO S O

MM1092.00 81129-83-1 250mg NH2 HN

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-129
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM1092.20- H 2N
(1S)-2,2-Dimethylcyclopropanecarboxamide 75885-58-4 25mg
0025
O

MM0024.02 L-Cysteine 52-90-4 100mg HS OH


NH2

Cilazapril
OH
O
O

MM3519.00 Cilazapril Monohydrate 92077-78-6 250mg


H
N N
N
H2 O

O O

Cilostazol
H
N O
N N
N

MM0796.00 Cilostazol 73963-72-1 250mg N O

3,4-Dehydrocilostazol (6-[4-(1-Cyclohexyl-1H-tetrazol-5-yl)- H
N O
N N
butoxy]-1H-quinolin-2-one) N
N O
MM0796.01 73963-62-9 100mg
Related compound B (USP): 6-[4-(1-Cyclohexyl-1H-tetrazol-
5-yl)-butoxy]-1H-quinolin-2-one
3,4-Dehydrocilostazol (6-[4-(1-Cyclohexyl-1H-tetrazol-5-yl)- H
N O
N N
MM0796.01- butoxy]-1H-quinolin-2-one) N
N O
73963-62-9 25mg
0025 Related compound B (USP): 6-[4-(1-Cyclohexyl-1H-tetrazol-
5-yl)-butoxy]-1H-quinolin-2-one
6-Hydroxy-3,4-dihydro-1H-quinolin-2-one H
N O
MM0796.02 Related compound A (USP): 6-hydroxy-3,4-dihydro-1H-quinolin- 54197-66-9 100mg
2-one HO

MM0796.02- 6-Hydroxy-3,4-dihydro-1H-quinolin-2-one H
N O
Related compound A (USP): 6-hydroxy-3,4-dihydro-1H-quinolin- 54197-66-9 25mg
0025 2-one HO

1-(4-(5-Cyclohexyl-1H-tetrazol-1-yl)butyl)-6-(4-(1-cyclohexyl-
1H-tetrazol-5-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one N
N

Related compound C (USP): 1-(4-(5-Cyclohexyl-1H-tetrazol-1- N O N N


N N
MM0796.03 865792-18-3 100mg N
N O

yl)butyl)-6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-3,4-
dihydroquinolin-2(1H)-one
N N
N
N Cl
MM0796.04-
5-(4-Chlorobutyl)-1-cyclohexyl-1H-tetrazole 73963-42-5 25mg
0025

N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20

Cimetidine
N
N N

MM0020.00 Cimetidine 51481-61-9 500mg HN


S
N N
H H

Impurity A (EP): 3-Cyano-2-methyl-1-[2- N N


N

MM0020.08 [[(5-methyl-1H-imidazol-4-yl)methyl]- 52378-40-2 100mg HN


S
N S
H
sulphanyl]ethyl]isothiourea

MM0020.08- Impurity A (EP): 3-Cyano-2-methyl-1-[2- N N


N

[[(5-methyl-1H-imidazol-4-yl)methyl]- 52378-40-2 25mg HN


S
N S
H
0025 sulphanyl]ethyl]isothiourea
Impurity B (EP): 3-Cyano-2-methyl-1-[2- N N
N

MM0020.12 [[(5-methyl-1H-imidazol-4-yl)methyl]- 138035-55-9 100mg HN


S
N O
H
sulphanyl]ethyl]isourea

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-130
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0020.12- Impurity B (EP): 3-Cyano-2-methyl-1-[2- N N


N

[[(5-methyl-1H-imidazol-4-yl)methyl]- 138035-55-9 25mg HN


S
N O
H
0025 sulphanyl]ethyl]isourea
Impurity C (EP) as Dihydrochloride: 1-[(Methyl-
amino)[[2-[[(5-methyl-1H-imidazol-4-yl)- O

methyl]sulphanyl]ethyl]amino]methylene]urea
N N NH2
HN HCl
MM0020.03 52568-80-6 100mg S
N N 2
H H

Dihydrochloride
(Cimetidine Amide Dihydrochloride)
Impurity C (EP) as Dihydrochloride: 1-[(Methyl-
MM0020.03- amino)[[2-[[(5-methyl-1H-imidazol-4-yl)- O

methyl]sulphanyl]ethyl]amino]methylene]urea
N N NH2
HN HCl
52568-80-6 25mg S
N N 2
H H
0025 Dihydrochloride
(Cimetidine Amide Dihydrochloride)
Impurity D (EP) as Dihydrochloride:
1-Methyl-3-[2-[[(5-methyl-1H-imidazol-4- HN
N
S
N
NH

N
HCl
MM0020.06 59660-24-1 100mg
yl)methyl]sulphanyl]ethyl]guanidine H H 2

Dihydrochloride
Impurity D (EP) as Dihydrochloride:
MM0020.06- 1-Methyl-3-[2-[[(5-methyl-1H-imidazol-4- HN
N
S
N
NH

N
HCl
59660-24-1 25mg
yl)methyl]sulphanyl]ethyl]guanidine H H 2

0025
Dihydrochloride
Impurity E (EP): 2-Cyano-1-methyl-3-[2-[[(5- N

methyl-1H-imidazol-4-yl)methyl]sulphinyl]- HN
N O
S
N
MM0020.04 54237-72-8 100mg
ethyl]guanidine N
H
N
H

(Cimetidine Sulphoxide)
Impurity E (EP): 2-Cyano-1-methyl-3-[2-[[(5- N
MM0020.04- methyl-1H-imidazol-4-yl)methyl]sulphinyl]- HN
N O
S
N

54237-72-8 25mg
0025 ethyl]guanidine N
H
N
H

(Cimetidine Sulphoxide)
N
N
MM0020.15 Impurity G (EP): 2-Cyano-1,3-dimethylguanidine 31857-31-5 100mg
N N
H H

MM0020.15- N
Impurity G (EP): 2-Cyano-1,3-dimethylguanidine 31857-31-5 25mg
0025
N N
H H
N

Impurity H (EP): 1,1'-(Disulphanediyldiethylene)- H


N
H
N
S
S
N
N

N
MM0020.07 74886-59-2 100mg
bis(2-cyano-3-methylguanidine)
H H
N
N

MM0020.07- Impurity H (EP): 1,1'-(Disulphanediyldiethylene)- H


N
H
N
S
S
N
N

N
74886-59-2 25mg
0025 bis(2-cyano-3-methylguanidine) N
N
H H

N
MM0020.11- Impurity I (EP) as Hydrochloride: (5-Methyl-1H-imidazol-4-yl) HN
OH HCl
38585-62-5 25mg
0025 methanol Hydrochloride
Impurity J (EP) as Dihydrobromide: 2-[[(5-Methyl- N
HN
MM0020.50 1H-imidazol-4-yl)methyl]sulphanyl]ethanamine 38603-73-5 100mg S
NH2 HBr
2

Dihydrobromide
H
N N
MM0020.10 1,1-Dimethyl-3-cyanoguanidine 1609-06-9 100mg
N
NH

H
MM0020.10- N N
1,1-Dimethyl-3-cyanoguanidine 1609-06-9 25mg
0025 N
NH

N
3-Cyano-2-ethyl-1-[2-[[(5-methyl-1H-imidazol-4-yl)methyl] N N
HN
MM0020.19 75850-09-8 100mg S
N O
sulphanyl]ethyl]isourea H

N
MM0020.19- 3-Cyano-2-ethyl-1-[2-[[(5-methyl-1H-imidazol-4-yl)methyl] N N
HN
75850-09-8 25mg S
N O
0025 H
sulphanyl]ethyl]isourea

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-131
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

H
H 2N N
MM0056.01 Cyanoguanidine 461-58-5 100mg N
NH

H
MM0056.01- H 2N N
Cyanoguanidine 461-58-5 25mg N
0025 NH

Cinacalcet Hydrochloride
F F

N F

MM3370.00 Cinacalcet Hydrochloride 364782-34-3 100mg H HCl

O F F

MM3370.01- N-[(1R)-1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl] N F
H
1005450-55-4 25mg
0025 propanamide
O F F

HO F
MM3370.02 3-[3-(Trifluoromethyl)phenyl]propanoic Acid 585-50-2 100mg

O F F

HO F
MM3370.03 3-(Trifluoromethyl)cinnamic Acid 779-89-5 100mg

O F F
MM3370.03- HO F
3-(Trifluoromethyl)cinnamic Acid 779-89-5 25mg
0025

MM3370.05- HCl
(1R)-1-(1-Naphthyl)ethylamine Hydrochloride 82572-04-1 25mg NH2
0025

(S)-Cinacalcet Hydrochloride F F

MM3370.06- N
H
F
HCl
Related compound D (USP): (S)-N-[1-(Naphthalen-1-yl) 1217809-88-5 25mg
0025
ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine

MM3370.07- N
H HCl
(R)-N-Benzyl-1-(naphthalen-1-yl)ethanamine Hydrochloride 163831-65-0 25mg
0025
F F
MM3370.08- 3-[3-(Trifluoromethyl)phenyl]propanol HO F
78573-45-2 100mg
0100 Related compound E (USP): USP monograph in draft

Cinchocaine Hydrochloride (Dibucaine Hydrochloride)


O
O N
MM0604.00-
Cinchocaine Hydrochloride
N
H
61-12-1 250mg N
HCl
0250
O

Impurity A (EP): 2-Chloro-N-[2-(diethylamino)ethyl]quinoline- Cl


N
H
N

MM0604.01 87864-14-0 100mg N


4-carboxamide

MM0604.01- Impurity A (EP): 2-Chloro-N-[2-(diethylamino)ethyl]quinoline- Cl


N
H
N

87864-14-0 25mg N
0025 4-carboxamide

O
HO
OH
Impurity B (EP): 2-Hydroxyquinoline-4-
MM0604.02 15733-89-8 100mg N
carboxylic Acid

O
HO
OH
MM0604.02- Impurity B (EP): 2-Hydroxyquinoline-4-
15733-89-8 25mg N
0025 carboxylic Acid

Impurity C (EP): N-[2-(Diethylamino)ethyl]-2- HO


N
H
N

MM0604.03 87864-08-2 50mg N


hydroxyquinoline-4-carboxamide

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-132
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
O
OH

MM0604.04 Impurity D (EP): 2-Butoxyquinoline-4-carboxylic Acid 10222-61-4 100mg N

O
O
MM0604.04- OH

Impurity D (EP): 2-Butoxyquinoline-4-carboxylic Acid 10222-61-4 25mg N


0025
O
+
O N
N
MM0604.05 Cinchocaine N-Oxide 87864-07-1 100mg N
H O

O
HO
O
MM0604.07 2-Hydroxy-4-quinolinecarboxylic Acid Methyl Ester 84906-82-1 100mg N

O
HO
MM0604.07- O
2-Hydroxy-4-quinolinecarboxylic Acid Methyl Ester 84906-82-1 25mg N
0025

Cineole (Eucalyptol)

O
MM1763.00 Cineole 470-82-6 250mg

Cinnamedrine Hydrochloride
OH

MM1992.00 Cinnamedrine Hydrochloride 25441-16-1 50mg N HCl

Cinnarizine
N
N

MM1038.00 Cinnarizine 298-57-7 250mg

NH
N

MM1038.01 Impurity A (EP): 1-(Diphenylmethyl)piperazine 841-77-0 100mg

NH
N
MM1038.01-
Impurity A (EP): 1-(Diphenylmethyl)piperazine 841-77-0 25mg
0025

Impurity B (EP): (Z)-1-(Diphenylmethyl)-4-(3- N


MM1038.03 750512-44-8 100mg N
phenylprop-2-enyl)piperazine

MM1038.03- Impurity B (EP): (Z)-1-(Diphenylmethyl)-4-(3- N


750512-44-8 25mg N
0025 phenylprop-2-enyl)piperazine

+
N

Impurity C (EP) as Chloride: (4-(Diphenylmethyl)-1,1-bis[(E)- N


Cl
MM1038.04 n/a 100mg
3-phenylprop-2-enyl]piperazinium Chloride
+
N

MM1038.04- Impurity C (EP) as Chloride: (4-(Diphenylmethyl)-1,1-bis[(E)- N


Cl
n/a 25mg
0025 3-phenylprop-2-enyl]piperazinium Chloride

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-133
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N
MM1038.06 Impurity E (EP): 1,4-Bis(diphenylmethyl)piperazine 216581-01-0 100mg N

MM1038.06- N
Impurity E (EP): 1,4-Bis(diphenylmethyl)piperazine 216581-01-0 25mg N
0025

O
+
N
MM1038.11- HCl
N 2

Cinnarizine N4-Oxide Dihydrochloride n/a 25mg


0025

Cinoxacin
O O

O
OH
MM1991.00 Cinoxacin 28657-80-9 100mg O N
N

Ciprofibrate
O
O
OH
MM1141.00 Ciprofibrate 52214-84-3 250mg Cl

Cl

Ciprofloxacin Hydrochloride
HN
MM0018.00- N N
Ciprofloxacin 85721-33-1 250mg OH
0250 F
O O

HN
Ciprofloxacin Hydrochloride N N
MM0018.06
Monohydrate
86393-32-0 500mg HCl
OH
F
H2 O
O O

Impurity A (EP): 7-Chloro-1-cyclopropyl-6- Cl N


MM0018.01 fluoro-4-oxo-1,4-dihydroquinoline-3- 86393-33-1 100mg OH
carboxylic Acid (Fluoroquinolonic Acid) F
O O

MM0018.01- Impurity A (EP): 7-Chloro-1-cyclopropyl-6- Cl N


fluoro-4-oxo-1,4-dihydroquinoline-3- 86393-33-1 25mg OH
0025 carboxylic Acid (Fluoroquinolonic Acid) F
O O

Impurity B (EP): 1-Cyclopropyl-4-oxo-7- HN


N N
MM0018.05 (piperazin-1-yl)-1,4-dihydroquinoline-3- 93107-11-0 100mg OH

carboxylic Acid (Desfluoro Compound) O O

MM0018.05- Impurity B (EP): 1-Cyclopropyl-4-oxo-7- HN


N N

(piperazin-1-yl)-1,4-dihydroquinoline-3- 93107-11-0 25mg OH


0025 carboxylic Acid (Desfluoro Compound) O O

Impurity C (EP): 7-(2-Aminoethylamino)-1-


cyclopropyl-6-fluoro-4-oxo-1,4- H 2N
H
N N

MM0018.04 103222-12-4 50mg


dihydroquinoline-3-carboxylic Acid F
O O
OH

(Ethylenediamine Compound)
Impurity C (EP) as Hydrochloride: 7-[(2-Aminoethyl)amino]-1-
H
MM0018.12- cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic H 2N
N N
HCl
528851-31-2 25mg F
OH
0025 Acid Hydrochloride (Ethylenediamine Compound O O

Hydrochloride)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-134
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity D (EP): 7-Chloro-1-cyclopropyl-4-oxo-


6-(piperazin-1-yl)-1,4-dihydroquinoline- Cl N

MM0018.02 3-carboxylic Acid 133210-96-5 50mg N


OH

Related compound A (USP): 7-Chloro-1-cyclopropyl-4-oxo- HN O O

6-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid
HN
Impurity E (EP): 1-Cyclopropyl-6-fluoro-7- N N
MM0018.03 (piperazin-1-yl)-quinolin-4(1H)-one 105394-83-0 100mg
(Decarboxylated Compound) F
O

HN

MM0018.03- Impurity E (EP): 1-Cyclopropyl-6-fluoro-7- N N


(piperazin-1-yl)-quinolin-4(1H)-one 105394-83-0 25mg
0025 (Decarboxylated Compound) F
O

6-(2-Aminoethylamino)-7-chloro-1- Cl N

MM0018.10 cyclopropyl-4-oxo-1,4-dihydroquinoline- 528851-30-1 100mg H 2N


N
OH
HCl

3-carboxylic Acid Hydrochloride H


O O

MM0018.10- 6-(2-Aminoethylamino)-7-chloro-1- Cl N

cyclopropyl-4-oxo-1,4-dihydroquinoline- 528851-30-1 25mg H 2N


N
OH
HCl

0025 3-carboxylic Acid Hydrochloride H


O O

MM0018.13- 1-Cyclopropyl-6-fluoro-4-oxo-7-(3-oxopiperazin- HN

1-yl)-1,4-dihydroquinoline-3-carboxylic Acid 103237-52-1 25mg N N

OH
0025 (Oxociprofloxacin) F
O O

O N
MM0018.16- N N

Ciprofloxacin Formamide (N-Formylciprofloxacin) 93594-39-9 25mg F


OH
0025 O O

HN
MM0018.17- N N

Ciprofloxacin Methyl Ester 107884-23-1 25mg O


0025 F
O O

HN
MM0018.18- N N

Ciprofloxacin Ethyl Ester 105404-65-7 25mg F


O
0025 O O

HN
MM0018.19- N N

Ciprofloxacin Isopropyl Ester 1427036-10-9 25mg F


O
0025 O O

MM0018.24- Methyl 3-Cyclopropylamino-2-(2,4-dichloro-5-fluorobenzoyl) Cl Cl NH


105392-26-5 25mg O
0025 acrylate F
O O

Citalopram Hydrobromide
F

HBr

MM0242.00 Citalopram Hydrobromide 59729-32-7 250mg N


O

MM0242.06 Citalopram Hydrochloride 85118-27-0 250mg N


HCl

Impurity A (EP): (1RS)-1-[3-(Dimethylamino)-


F
propyl]-1-(4-fluorophenyl)-1,3-dihydro-
MM0242.14- isobenzofuran-5-carboxamide (Citalopram-
Amide) N
64372-56-1 25mg
0025 O
H2 N

Related compound A (USP): 1-(3-dimethylaminopropyl)-1- O

(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carboxamide
Impurity B (EP) as Oxalate: 1-[3-(Dimethylamino)propyl]-1-(4-
fluorophenyl)-3-hydroxy-1,3-dihydroisobenzofuran-5- F

MM0242.21- O OH
carbonitrile Oxalate (3-Hydroxycitalopram Oxalate)
1332724-03-4 25mg O
N O OH
0025 Related compound B (USP): 1-[3-(dimethylamino)propyl]-1- N OH

(4-fluorophenyl)-3-hydroxy-1,3-dihydroisobenzofuran-5-
carbonitrile

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-135
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

F
Impurity C (EP): (3RS)-6-Cyano-3-[3-(dimethyl-
amino)propyl]-3-(4-fluorophenyl)isobenzofuran-
1(3H)-one
MM0242.17 372941-54-3 100mg N
O

Related compound C (USP) N O

F
Impurity C (EP): (3RS)-6-Cyano-3-[3-(dimethyl-
MM0242.17- amino)propyl]-3-(4-fluorophenyl)isobenzofuran-
1(3H)-one
372941-54-3 25mg N
0025 O

Related compound C (USP) N O

Impurity C (EP) as Oxalate: (3RS)-6-Cyano-3-[3- F

MM0242.20- (dimethylamino)propyl]-3-(4-fluorophenyl)isobenzofuran-1 O OH

1440961-11-4 25mg N

0025 (3H)-one Oxalate N


O
O OH

Related compound C (USP) O

Impurity D (EP) as Hydrochloride: (1RS)-1-(4-


Fluorophenyl)-1-[3-(methylamino)propyl]-1,3- F

MM0242.09- dihydroisobenzofuran-5-carbonitrile Hydro- HCl

chloride (Desmethylcitalopram Hydrochloride)


97743-99-2 25mg N
H
0025 O

Related compound D (USP): 1-(4-Fluorophenyl)-1-(3- N

methylaminopropyl)-1,3-dihydroisobenzofuran-5-carbonitrile
Impurity E (EP) as Oxalate: 3-[(1RS)-5-Chloro-1-
F

(4-fluorophenyl)-1,3-dihydroisobenzofuran-1- HO O

MM0242.12 yl]-N,N-dimethylpropan-1-amine Oxalate n/a 50mg N HO O

Related compound G (USP): 1-(4'-fluorophenyl)-1-(3- Cl


O

dimethylaminopropyl)-5-chlorophthalane
Impurity F (EP) as Hydrobromide: 3-[(1RS)-5-Bromo-1-(4- F

fluorophenyl)-1,3-dihydroisobenzofuran-1-yl]-N,N- HBr
MM0242.04-
dimethylpropan-1-amine Hydrobromide 479065-02-6 25mg
0025 N
O
Related compound H (USP): 1-(4'-fluorophenyl)-1-(3- Br

dimethylaminopropyl)-5-bromophthalane

Impurity F (EP) as Hydrogen Oxalate: 3-[(1RS)-5-Bromo-1-


(4-fluorophenyl)-1,3-dihydroisobenzofuran-1-yl]-N,N- F

HO O
MM0242.13-
dimethylpropan-1-amine Hydrogen Oxalate 64372-43-6 25mg N HO O
0025 O
Br

Related compound H (USP): 1-(4'-fluorophenyl)-1-(3-


dimethylaminopropyl)-5-bromophthalane

MM0242.28- Impurity G (EP) as Dihydrobromide: 4-(Dimethylamino)-1- F

[(1RS)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3- n/a 25mg O


N
HBr
2
0025 dihydroisobenzofuran-5-yl]butan-1-one Dihydrobromide O

Citalopram N-Oxide
Related compound E (USP) +
MM0242.10 63284-72-0 100mg N
O O

MM0242.23 5-Cyanophthalide 82104-74-3 100mg O

MM0242.23-
5-Cyanophthalide 82104-74-3 25mg O
0025
N

Citadiol Hydrobromide (4-[4-(Dimethylamino)-1-(4-


MM0242.26- HBr
fluorophenyl)-1-hydroxybutyl]-3-(hydroxymethyl)benzonitrile 103146-26-5 25mg N
OH
0025
N
Hydrobromide) OH

MM0242.29-
1-(4-Fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile 64169-67-1 25mg
0025
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-136
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0242.31- 1-(4-Fluorophenyl)-3-oxo-1,3-dihydroisobenzofuran-5-
372941-46-3 25mg
0025 carboxamide O
H 2N

O O

Citicoline Sodium
O N NH2
O O O O
MM3913.00- N
+

O
P
O
P
O
O
N

Citicoline Sodium 33818-15-4 250mg Na


+

HO OH
0250

Citric Acid Anhydrous


O OH
O O
MM0988.00 Citric Acid Anhydrous 77-92-9 250mg HO
HO OH

Citric Acid Monohydrate


O OH
O HO O
MM0575.00 Citric Acid Monohydrate 5949-29-1 500mg H2O
HO OH

Cladribine
NH2

N
N

Cl N N
MM3381.00 Cladribine 4291-63-8 250mg
O

OH
HO

NH2
H
Impurity C (EP): 2-Chloro-7H-purin-6-amine (2- N
N
MM3381.01 1839-18-5 100mg
Chloroadenine)
Cl N N

NH2
H
MM3381.01- Impurity C (EP): 2-Chloro-7H-purin-6-amine (2- N
N
1839-18-5 25mg
0025 Chloroadenine)
Cl N N

O
MM0344.12- O
Impurity G (EP): Methyl 4-Methylbenzoate 99-75-2 100mg
0100

Clarithromycin
O

OH
O HO
O
O
MM0057.00- O
Clarithromycin 81103-11-9 250mg OH O O
0250 N
O

HO O

OH

Impurity E (EP): 6,11-Di-O-methylerythromycin A O


O
O O

MM0057.05- O
Related compound A (USP): 6,11-di-O-methylerythromycin 81103-14-2 25mg OH O O
N
A
0025 O

HO O

OH
O HO
O
O
MM0057.17- O
Clarithromycin N-Oxide 118074-07-0 25mg O N+
OH O O
0025 O

HO O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-137
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
O HO HO

O O
MM0132.13 N-Demethylerythromycin A 992-62-1 100mg N
H
OH O O
O

HO
O

OH
O HO HO

MM0132.13- O O
N-Demethylerythromycin A 992-62-1 25mg N
H
OH O O
0025 O

HO
O

Clavulanate Potassium, see Potassium Clavulanate

Clebopride Malate
O
O N HO

MM3600.00 Clebopride Malate 57645-91-7 100mg Cl

H 2N O
N
H HO

O
OH

Clemastine Fumarate

O N

MM1444.00 Clemastine Fumarate 14976-57-9 250mg Cl


O
HO
OH
O

MM1444.01 Impurity C (EP): (RS)-1-(4-Chlorophenyl)-1-phenylethanol 59767-24-7 100mg


OH

Cl

Clenbuterol Hydrochloride
OH
H
Cl N

MM1299.00 Clenbuterol Hydrochloride 21898-19-1 250mg H2 N


Cl HCl

Impurity B (EP) as Hydrochloride: 1-(4-Amino-3,5-


O
dichlorophenyl)-2-[(1,1-dimethylethyl)amino]ethanone Cl
H
N
HCl
MM1299.07 Hydrochloride 37148-49-5 100mg H 2N
Cl
Related compound B (USP): 1-(4-amino-3,5-dichlorophenyl)-
2-tert-butylaminoethanone
Impurity B (EP) as Hydrochloride: 1-(4-Amino-3,5-
O
dichlorophenyl)-2-[(1,1-dimethylethyl)amino]ethanone Cl
H
N
MM1299.07- HCl
Hydrochloride 37148-49-5 25mg H 2N
0025 Cl
Related compound B (USP): 1-(4-amino-3,5-dichlorophenyl)-
2-tert-butylaminoethanone

Clidinium Bromide

OH

MM1798.00 Clidinium Bromide 3485-62-9 100mg O Br

O +
N

HO
3-Hydroxy-1-methylquinuclindinium Bromide
MM1798.01-
Related compound A (USP): 3-Hydroxy-1- 2096336-00-2 25mg + Br
0025 N
methylquinuclindinium

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-138
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Clindamycin Hydrochloride
Cl

H
N N
MM0259.00- O S
H
Clindamycin Hydrochloride 21462-39-5 250mg O
0250 HO OH
HCl OH

Impurity A (EP) as Hydrochloride Monohydrate: Methyl 6,8-


Dideoxy-6-[[[(2S,4R)-1-methyl-4-propylpyrrolidin-2-yl] N OH
H
N

HCl H2O
O H O
MM0320.00 carbonyl]amino]-1-thio-D-erythro- -D-galacto-octopyranoside 7179-49-9 250mg HO S

HO OH
Hydrochloride Monohydrate (Lincomycin Hydrochloride
Monohydrate)
N Cl
H
N
H
O O
O S
MM0259.07 Triacetylclindamycin n/a 100mg O
O O
O
O

N Cl
H
N
H
MM0259.07- O O
O S
Triacetylclindamycin n/a 25mg O
0025 O O
O
O

Clindamycin Palmitate Hydrochloride


OH
H
Cl OH
O
O H
N O

Clindamycin Palmitate Hydrochloride


H O
N S

MM1989.00 25507-04-4 250mg HCl

OH
H
Cl OH
O
O H
N O
MM1989.08- N
H

O
S
O

Clindamycin Palmitate Sulfoxide Hydrochloride 2126928-92-3 50mg HCl

0050

Clindamycin Phosphate
Cl

H
N N
O S

MM1520.00 Clindamycin Phosphate 24729-96-2 250mg O


HO
H
O
O
P OH
OH
OH

Impurity A (EP) as Hydrochloride Monohydrate: Methyl 6,8-


Dideoxy-6-[[[(2S,4R)-1-methyl-4-propylpyrrolidin-2-yl] N OH
H
N

HCl H2O
O H O
MM0320.00 carbonyl]amino]-1-thio-D-erythro- -D-galacto-octopyranoside 7179-49-9 250mg HO S

HO OH
Hydrochloride Monohydrate (Lincomycin Hydrochloride
Monohydrate)
N Cl
H
N

O O O
MM1520.02 Clindamycin Phosphate Sulfoxide 1228573-90-7 100mg HO S
O
HO O P
OH
OH

N Cl
H
N

MM1520.02- O O O
Clindamycin Phosphate Sulfoxide 1228573-90-7 25mg HO S

0025 O
HO O P
OH
OH

N Cl
H
N

O O O
O
MM1520.03 Clindamycin Phosphate Sulfone n/a 100mg HO S
O
HO O P
OH
OH

N Cl
H
N

MM1520.03- O O O
O
Clindamycin Phosphate Sulfone n/a 25mg HO S
O
0025 HO O P
OH
OH

O
+
N Cl
H
N
MM1520.04- O O O
Clindamycin Phosphate Sulfoxide trans-N-Oxide n/a 25mg HO S
0025 O
HO O P
OH
OH

Cl
O O
O
O S
MM1520.05- +
N
H
Clindamycin Phosphate Sulfone trans-N-Oxide n/a 25mg N
HO O
O
0025 OH P OH
O OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-139
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N Cl
H
N

O O
O S
MM1520.07 Diacetylclindamycin Phosphate n/a 100mg O O
O O P
OH
OH
O

N Cl
H
N

MM1520.07- O O
O S
Diacetylclindamycin Phosphate n/a 25mg O O
0025 O O P
OH
OH
O

Clioquinol
OH
I N

MM0312.00 Clioquinol 130-26-7 500mg

Cl

OH
N

MM0312.01 Impurity A (EP): 5-Chloroquinolin-8-ol 130-16-5 100mg

Cl

OH
Cl N

MM0312.02 Impurity B (EP): 5,7-Dichloroquinolin-8-ol 773-76-2 100mg

Cl

OH
Cl N
MM0312.02-
Impurity B (EP): 5,7-Dichloroquinolin-8-ol 773-76-2 25mg
0025
Cl

OH
I N
MM0312.03-
Impurity C (EP): 5,7-Diiodoquinolin-8-ol (Iodoquinol) 83-73-8 25mg
0025
I

Clobazam
O
N

MM0910.00-
Clobazam 22316-47-8 CS 250mg Cl N
0250 O

H O
N
Impurity A (EP): 7-Chloro-5-phenyl-1,5-dihydro-
3H-1,5-benzodiazepine-2,4-dione Cl N
MM0910.01
(Norclobazam)
22316-55-8 100mg O

Related compound A (USP)

H O
N
Impurity A (EP): 7-Chloro-5-phenyl-1,5-dihydro-
MM0910.01- 3H-1,5-benzodiazepine-2,4-dione Cl N
(Norclobazam)
22316-55-8 25mg O
0025
Related compound A (USP)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-140
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Clobenzorex Hydrochloride
MM0649.00- H

Clobenzorex Hydrochloride 5843-53-8 250mg N

Cl
HCl

0250

Clobetasol Propionate
Cl
O O

HO O
MM0769.00 Clobetasol Propionate 25122-46-7 100mg H

F H
O

OH
MM0769.10- Impurity F (EP): 9-Fluoro-11 -hydroxy-16 -methyl-3- HO

2412496-00-3 25mg H

0025 oxopregna-1,4,17(20)-trien-21-oic Acid F H


O

Impurity G (EP): 21-Chloro-9-fluoro-11 ,17- HO OH


Cl

MM0200.01 dihydroxy-16 -methylpregna-1,4-diene- 25122-41-2 100mg H

F H
3,20-dione (Clobetasol) O

Impurity K (EP): 9-Fluoro-11 ,17-dihydroxy- O


O
O

MM0202.04 16 -methyl-3,20-dioxopregna-1,4-dien- 75883-07-7 100mg HO OH


H
21-yl Propanoate (Betamethasone 21- F H

Propionate) O

Impurity K (EP): 9-Fluoro-11 ,17-dihydroxy- O


O
O

MM0202.04- 16 -methyl-3,20-dioxopregna-1,4-dien- 75883-07-7 25mg HO OH


H
0025 21-yl Propanoate (Betamethasone 21- F H

Propionate) O

OH
HO
MM0200.11- 9-Fluoro-11 ,21-dihydroxy-16-methylpregna-1,4,16-triene- H
59860-99-0 25mg
0025 3,20-dione F H
O

O
HO O
MM0213.20- H
Dexamethasone Oxetanone 4089-36-5 25mg
0025 F H
O

Clobetasone Butyrate
Cl
O O

O O

MM0207.00 Clobetasone Butyrate 25122-57-0 250mg H

F H
O

Clobutinol Hydrochloride
N

MM0038.00 Clobutinol Hydrochloride 1215-83-4 100mg OH


HCl

Cl

N
MM0038.01 1-Dimethylamino-2-methylbutan-3-one 22104-62-7 100mg
O

Clocortolone Pivalate
O O

HO O

H
MM3743.00 Clocortolone Pivalate 34097-16-0 250mg Cl H
O
F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-141
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Clofarabine
N H2

N
N

Cl N N
F
MM3521.00 Clofarabine 123318-82-1 250mg
O

OH

OH

Clofazimine

N
N Cl

MM1988.00 Clofazimine 2030-63-9 250mg Cl N


H
N

Clofibrate
O
O
MM1934.00 Clofibrate 637-07-0 250mg O

Cl

O
MM1934.01- O
O
Methyl 2-(4-Chlorophenoxy)-2-methylpropionate 55162-41-9 100mg
0100 Cl

Clomethiazole Edisylate
Cl
O O

MM1866.00 Clomethiazole Edisylate 1867-58-9 100mg S


HO
S

O
S
O
OH

N
2

N
MM0049.02 5-(2-Hydroxyethyl)-4-methylthiazole 137-00-8 100mg
S OH

Clomifene Citrate (Clomiphene Citrate)


O
O OH
N
OH

MM0650.00 Clomifene Citrate 50-41-9 250mg Cl


OH
O

OH
O

Impurity A (EP) as Hydrochloride: 2-[4-(1,2-Diphenylethenyl) O


N

MM0650.04 phenoxy]-N,N-diethylethanamine Hydrochloride 74056-26-1 100mg


Related compound A (USP): (E,Z)-2-[4-(1,2-diphenylethyl) HCl

phenoxy]-N,N-diethylethanamine
O
N

Impurity B (EP): [4-[2-(Diethylamino)ethoxy]phenyl] O

MM0650.05 796-77-0 100mg


phenylmethanone

O +
N
O

MM0650.01 Clomifene N-Oxide Hydrochloride 97986-33-9 100mg Cl

HCl

O
N
H

MM0650.03 Desethylclomifene Hydrochloride 1310815-19-0 100mg Cl

HCl

O
N
MM0650.03- H

Desethylclomifene Hydrochloride 1310815-19-0 25mg Cl

0025 HCl

O
N
OH

MM0650.10 1-[4-[2-(Diethylamino)ethoxy]phenyl]-1,2-diphenylethanol 73404-00-9 100mg

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-142
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
N
OH
MM0650.10-
1-[4-[2-(Diethylamino)ethoxy]phenyl]-1,2-diphenylethanol 73404-00-9 25mg
0025

Clomiphene Citrate, see Clomifene Citrate

Clomipramine Hydrochloride
Cl
HCl

N
MM0545.00 Clomipramine Hydrochloride 17321-77-6 500mg N

Impurity A (EP) as Dihydrochloride: N-[3-(3-


Chloro-10,11-dihydro-5H-dibenzo[b,f]azepin- Cl

MM0545.01- 5-yl)propyl]-N,N',N'-trimethylpropane-1,3- HCl


2

diamine Dihydrochloride n/a 25mg N N N

0025 Related compound A (USP): N^1-[3-(3-Chloro-10,11-


dihydro-5H-dibenzo[b,f]azepin-5-yl)propyl]-N^1,N^3,N^3-
trimethylpropane-1,3-diamine

MM0077.00- Impurity B (EP) as Hydrochloride: N N HCl


113-52-0 250mg
0250 Imipramine Hydrochloride

Impurity C (EP) as Hydrochloride: 3-(3-Chloro-5H- Cl

MM0545.03- dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-
HCl
1-amine Hydrochloride n/a 25mg N N

0025 Related compound C (USP): 3-(3-Chloro-5H-dibenzo[b,f]


azepin-5-yl)-N,N-dimethylpropan-1-amine
Impurity D (EP) as Hydrochloride: 3-(3,7-Dichloro- Cl

MM0545.04- 10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,N-
HCl
dimethylpropan-1-amine Hydrochloride 115189-28-1 25mg N N

0025 Related compound D (USP): 3-(3,7-Dichloro-10,11-dihydro- Cl

5H-dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine

Impurity E (EP): 10,11-Dihydro-5H-dibenzo[b,f]- NH


MM0076.06 494-19-9 100mg
azepine (Iminodibenzyl)

MM0076.06- Impurity E (EP): 10,11-Dihydro-5H-dibenzo[b,f]- NH


494-19-9 25mg
0025 azepine (Iminodibenzyl)

Cl

Impurity F (EP): 3-Chloro-10,11-dihydro-5H-


dibenzo[b,f]azepine
NH
Related compound F (USP): 3-Chloro-10,11-dihydro-5H-
MM0545.06 32943-25-2 100mg
dibenzo[b,f]azepine

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-143
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cl

Impurity F (EP): 3-Chloro-10,11-dihydro-5H-


MM0545.06- dibenzo[b,f]azepine
NH
Related compound F (USP): 3-Chloro-10,11-dihydro-5H-
32943-25-2 25mg
0025
dibenzo[b,f]azepine

Cl

Impurity G (EP): 3-Chloro-5-(prop-2-enyl)-10,11-


MM0545.07 n/a 50mg N
dihydro-5H-dibenzo[b,f]azepine

Cl

HCl
MM0545.08 Desmethylclomipramine Hydrochloride 29854-14-6 100mg N N
H

Cl

MM0545.08- HCl
Desmethylclomipramine Hydrochloride 29854-14-6 25mg N N
H
0025

Cl

MM0545.09 Clomipramine N-Oxide 14171-67-6 100mg N N


+
O

Cl

MM0545.09-
Clomipramine N-Oxide 14171-67-6 25mg N N
+
O
0025

Cl

3-Chloro-10-[3-(dimethylamino)propyl]- N N
9-acridanone
MM0545.13 1783028-21-6 100mg
O

Cl

MM0545.13- 3-Chloro-10-[3-(dimethylamino)propyl]- N N
9-acridanone
1783028-21-6 25mg
0025 O

Clonazepam
H O
N

MM0945.00- O +
N
Clonazepam 1622-61-3 CS 250mg N

0250 O
Cl

NH2
Impurity A (EP): (2-Amino-5-nitrophenyl)(2-
O O
chlorophenyl)methanone N
+

Related compound B (USP): 2-Amino-2'-chloro-5-


MM0945.01 2011-66-7 100mg O Cl

nitrobenzophenone
NH2
Impurity A (EP): (2-Amino-5-nitrophenyl)(2-
O O
MM0945.01- chlorophenyl)methanone N
+

Related compound B (USP): 2-Amino-2'-chloro-5-


2011-66-7 25mg O Cl
0025
nitrobenzophenone
H
Impurity B (EP): 3-Amino-4-(2-chlorophenyl)- N O

MM0945.02- 6-nitroquinolin-2(1H)-one O
N
+
NH2

Related compound A (USP): 3-Amino-4-(2-chlorophenyl)-6-


55198-89-5 25mg O Cl
0025
nitrocarbostyril

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-144
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
N

O +
MM0945.04 Methylclonazepam 5527-71-9 50mg N N
O
Cl

O
Br
NH
2-Bromo-2'-(2-chlorobenzoyl)-4'-nitroacetanilide
O O
MM0945.05 Related compound C (USP): 2-bromo-2'-(2-chlorobenzoyl)- 52130-87-7 50mg N
+

4'-nitroacetanilide O Cl

O
NH2
NH

MM0945.06- 2-Amino-N-[2-(2-chlorobenzoyl)-4-nitrophenyl]acetamide HCl


O + O
94006-04-9 25mg N
0025 Hydrochloride O Cl

H
N
N
MM0945.08- O +
N
3-(2-Chlorophenyl)-5-nitro-1H-indazole n/a 25mg Cl
0025 O

O + N
MM0945.09- N
4-(2-Chlorophenyl)-6-nitroquinazoline 1647150-35-3 25mg O Cl
0025

O
N
O
MM0945.10- 2-Hydroxypropyl 4-(2-Chlorophenyl)-6-nitroquinazoline-2- O
N
+ N OH
n/a 25mg O Cl
0025 carboxylate
N H2
O
O + N
MM0945.12- 2-[[(2-Amino-5-nitrophenyl)(2-chlorophenyl)methylene]amino] N O
n/a 25mg O Cl

0025 acetic Acid Ethyl Ester

Clonidine Hydrochloride
Cl
HN
MM0983.00-
Clonidine Hydrochloride 4205-91-8 250mg N N
H
HCl

0250 Cl

HN

MM0983.04 Impurity A (EP): 1-Acetylimidazolidin-2-one 5391-39-9 100mg O N

HN
MM0983.04- N
Impurity A (EP): 1-Acetylimidazolidin-2-one 5391-39-9 25mg O
0025
O

Cl
N
MM0983.03- Impurity B (EP): 1-Acetyl-2-[(2,6-dichloro-
54707-71-0 25mg N N
0025 phenyl)amino]-4,5-dihydro-1H-imidazole Cl
H
O

N H2
Cl Cl
MM0006.21 Impurity C (EP): 2,6-Dichloroaniline 608-31-1 100mg

N H2
MM0006.21- Cl Cl
Impurity C (EP): 2,6-Dichloroaniline 608-31-1 25mg
0025

Cl
S

MM0983.02 1-(2,6-Dichlorophenyl)thiourea 6590-91-6 100mg N NH2


H
Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-145
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cl
S
MM0983.02-
1-(2,6-Dichlorophenyl)thiourea 6590-91-6 25mg N NH2
0025 H
Cl

Clopamide
O

MM0063.03 Impurity B (EP): 4-Chlorobenzoic Acid 74-11-3 100mg OH

Cl

O
MM0063.03- OH
Impurity B (EP): 4-Chlorobenzoic Acid 74-11-3 25mg
0025
Cl

O O O
S
H 2N OH
MM0477.04 Impurity C (EP): 4-Chloro-3-sulfamoylbenzoic Acid 1205-30-7 100mg
Cl

O O O
MM0477.04- S
H 2N OH
Impurity C (EP): 4-Chloro-3-sulfamoylbenzoic Acid 1205-30-7 25mg
0025 Cl

Clopidogrel Hydrogen Sulfate

MM0455.10- O
Cl
Clopidogrel Hydrogen Sulfate 120202-66-6 250mg N
O
HO S
O
OH

0250 S
O

Impurity A (EP) as Hydrochloride: (2S)-(2-Chlorophenyl)[6,7-


MM0455.04- dihydrothieno[3,2-c]pyridin-5(4H)-yl]acetic Acid Hydrochloride Cl
HCl
OH
(Clopidogrel Acid Hydrochloride)
144750-42-5 25mg N
0025 O
Related compound A (USP) S

Impurity B (EP) as Racemate Hydrogen Sulfate:


Methyl (2RS)-(2-Chlorophenyl)[4,7-dihydro-
thieno[2,3-c]pyridin-6(5H)-yl]acetate Hydrogen Cl
HO
O
S OH
MM0455.13 2137493-39-9 100mg O
Sulfate S
N
O
O

Related compound B (USP): Methyl(+/-)-(o-chlorophenyl)-


4,5-dihydrothieno[2,3-c]pyridine-6(7H)-acetate
Impurity B (EP) as Racemate Hydrogen Sulfate:
Methyl (2RS)-(2-Chlorophenyl)[4,7-dihydro-
MM0455.13- thieno[2,3-c]pyridin-6(5H)-yl]acetate Hydrogen Cl
HO
O
S OH
2137493-39-9 25mg O

0025 Sulfate S
N
O
O

Related compound B (USP): Methyl(+/-)-(o-chlorophenyl)-


4,5-dihydrothieno[2,3-c]pyridine-6(7H)-acetate
Impurity B (EP) as Racemate Hydrochloride: Methyl (2RS)-
(2-Chlorophenyl)[4,7-dihydro-thieno[2,3-c]pyridin-6(5H)-yl]
MM0455.16- Cl HCl
acetate Hydrochloride 144750-52-7 25mg S O
N
0025 O
Related compound B (USP): Methyl(+/-)-(o-chlorophenyl)-
4,5-dihydrothieno[2,3-c]pyridine-6(7H)-acetate
Impurity C (EP) as Hydrogen Sulfate: Methyl
MM0455.12- (2R)-(2-Chlorophenyl)[6,7-dihydrothieno[3,2-c]- O
Cl
pyridin-5(4H)-yl]acetate Hydrogen Sulfate 120202-71-3 25mg N
O
HO S
O
OH

0025 ((R)-Clopidogrel Hydrogen Sulfate) S


O

Related compound C (USP)

Cl
MM0455.09 Clopidogrel Alcohol 1227294-01-0 100mg OH
N

MM0455.09- Cl
Clopidogrel Alcohol 1227294-01-0 25mg OH
0025 N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-146
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0455.20- N H2
2-(Thiophen-2-yl)ethylamine 30433-91-1 100mg
0100 S

MM0455.21- Cl
2-Amino-2-(2-chlorophenyl)acetic Acid 88744-36-9 25mg
0025 OH
H 2N
O

MM0455.22- Methyl (2S)-2-(2-Chlorophenyl)-2-[2-(thiophen-2-yl) Cl


141109-19-5 25mg O HCl
HN
0025 ethylamino]acetate Hydrochloride O
S

MM0455.23- NH
4,5,6,7-Tetrahydrothieno[3,2-c]pyridine Hydrochloride 28783-41-7 25mg HCl
0025 S

O OH
MM0455.24- Cl
HO
OH
Methyl (2S)-2-Amino-2-(2-chlorophenyl)acetate Tartrate 141109-15-1 25mg H2 N
O
OH O
0025 O

S
MM0150.00- N HCl
Ticlopidine Hydrochloride 53885-35-1 250mg
0250 Cl

MM0150.06 6,7-Dihydrothieno[3,2-c]-pyridin-4(5H)-one 68559-60-4 100mg HN

S
MM0150.06- HN
6,7-Dihydrothieno[3,2-c]-pyridin-4(5H)-one 68559-60-4 25mg
0025
O

MM0455.27- Cl
Methyl 2-Chloro-2-(2-chlorophenyl)acetate 90055-47-3 100mg
0100 O
Cl
O

Clopidol

Cl
N
MM0699.00 Clopidol 2971-90-6 250mg
HO
Cl

Cl
N
MM0699.01 3,5-Dichloro-2,6-dimethylpyridin-4-amine 50978-40-0 100mg
H 2N
Cl

Cl
MM0699.01- N
3,5-Dichloro-2,6-dimethylpyridin-4-amine 50978-40-0 25mg
0025 H 2N
Cl

Clorazepate Dipotassium, see Dipotassium Clorazepate Monohydrate

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-147
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Clorgyline Hydrochloride
Cl

MM3019.00 Clorgyline Hydrochloride 17780-75-5 50mg Cl


O N
HCl

Clorindione
O

MM3020.00 Clorindione 1146-99-2 50mg Cl

Clorprenaline Hydrochloride
OH
H
N
MM0716.02 Clorprenaline Hydrochloride 6933-90-0 250mg HCl

Cl

Clorsulon
O O O O
S S
H 2N N H2

MM1518.00 Clorsulon 60200-06-8 250mg Cl


N H2

Cl Cl

Clostebol Acetate
O

H
MM3725.00 Clostebol Acetate 855-19-6 250mg
H H
O
Cl

Clotrimazole

MM0015.00-
Clotrimazole 23593-75-1 250mg
0250 Cl N

Impurity A (EP): (2-Chlorophenyl)-


diphenylmethanol
MM0015.01 66774-02-5 100mg
Related compound A (USP): (o-chlorophenyl) Cl H O

diphenylmethanol

Impurity A (EP): (2-Chlorophenyl)-


MM0015.01- diphenylmethanol
Related compound A (USP): (o-chlorophenyl)
66774-02-5 25mg
0025 Cl H O

diphenylmethanol

Cl

Impurity B (EP): 1-[(4-Chlorophenyl)-


MM0015.10 23593-71-7 100mg
diphenylmethyl]-1H-imidazole N

Cl

MM0015.10- Impurity B (EP): 1-[(4-Chlorophenyl)-


23593-71-7 25mg
0025 diphenylmethyl]-1H-imidazole N

H
N
MM0015.02 Impurity D (EP): Imidazole 288-32-4 100mg
N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-148
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O Cl
Impurity E (EP): (2-Chlorophenyl)phenyl-
MM0015.06 5162-03-8 100mg
methanone (2-Chlorobenzophenone)

O Cl
MM0015.06- Impurity E (EP): (2-Chlorophenyl)phenyl-
5162-03-8 25mg
0025 methanone (2-Chlorobenzophenone)

Impurity F (EP): 1-(Triphenylmethyl)-1H-


MM0015.11 15469-97-3 100mg
imidazole (Deschloroclotrimazole) N

MM0015.11- Impurity F (EP): 1-(Triphenylmethyl)-1H-


15469-97-3 25mg
0025 imidazole (Deschloroclotrimazole) N

MM0015.04 (2-Chlorophenyl)diphenylmethane 56153-60-7 100mg Cl

MM0015.04-
(2-Chlorophenyl)diphenylmethane 56153-60-7 25mg Cl
0025

(2-Chlorophenyl)diphenylmethyl Ethyl
MM0015.05
Ether
717109-43-8 100mg
Cl O

MM0015.05- (2-Chlorophenyl)diphenylmethyl Ethyl


Ether
717109-43-8 25mg
0025 Cl O

(2-Chlorophenyl)phenyldichloro-
methane
MM0015.07 3509-85-1 100mg
Cl Cl Cl

MM0015.08 (2-Chlorophenyl)trichlormethane 2136-89-2 100mg Cl

Cl Cl Cl

MM0015.09- 1-[(2-Chlorophenyl)diphenylmethyl]-1H-
pyrazole
289905-88-0 25mg
0025 Cl N
N

Cloxacillin Sodium
Cl O +
O Na
O

MM0682.00 Cloxacillin Sodium Monohydrate 7081-44-9 500mg N


O
H
N
N

S
H2 O

H
O

O
OH
Impurity C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl- O
MM0026.04 7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- 551-16-6 100mg N

carboxylic Acid (6-Aminopenicillanic Acid) H 2N S


H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-149
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
OH
MM0026.04- Impurity C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl- O
7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- 551-16-6 25mg N
0025 carboxylic Acid (6-Aminopenicillanic Acid) H 2N S
H

Cl
Impurity D (EP): 3-(2-Chlorophenyl)-5-methyl-
isoxazole-4-carboxylic Acid N
Related compound D (USP): 3-(2-Chlorophenyl)-5-
MM0682.04 23598-72-3 100mg
O OH
methylisoxazole-4-carboxylic acid
O

Cl
Impurity D (EP): 3-(2-Chlorophenyl)-5-methyl-
MM0682.04- isoxazole-4-carboxylic Acid N
Related compound D (USP): 3-(2-Chlorophenyl)-5-
23598-72-3 25mg
0025 O OH
methylisoxazole-4-carboxylic acid
O

Cloxiquine
OH
N

MM0391.00 Cloxiquine 130-16-5 500mg

Cl

Clozapine
Cl N
N N
MM0480.00-
Clozapine 5786-21-0 250mg
0250 N
H

Cl
H
N O
Impurity A (EP): 8-Chloro-5,10-dihydro-11H-
MM0480.01 50892-62-1 100mg
dibenzo[b,e][1,4]diazepin-11-one N
H

Cl
H
N O
MM0480.01- Impurity A (EP): 8-Chloro-5,10-dihydro-11H-
50892-62-1 25mg
0025 dibenzo[b,e][1,4]diazepin-11-one N
H

H
N

Impurity B (EP): 11,11'-(Piperazine-1,4-diyl)bis(8-chloro-5H- Cl N N


MM0480.02 263366-81-0 50mg N N Cl

dibenzo[b,e][1,4]-diazepine) N
H

Cl NH

Impurity C (EP): 8-Chloro-11-(piperazin-1- N N

MM0480.03 6104-71-8 100mg


yl)-5H-dibenzo[b,e][1,4]diazepine N
H

Cl NH

MM0480.03- Impurity C (EP): 8-Chloro-11-(piperazin-1- N N

6104-71-8 25mg
0025 yl)-5H-dibenzo[b,e][1,4]diazepine N
H

Cl N H2

MM0480.06- Impurity D (EP): 1-[2-[(2-Amino-4-chlorophenyl)amino] NH O


65514-71-8 25mg
0025 benzoyl]-4-methylpiperazine N
N

Cl +
N O
N N

MM0480.07 Clozapine N-Oxide 34233-69-7 100mg


N
H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-150
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cobicistat
N
S
O
MM3623.01- Thiazol-5-ylmethyl N-((2R,5R)-5-Amino-1,6-diphenylhexan-2- H2 N HCl
N O
1247119-33-0 25mg H
0025 yl)carbamate Hydrochloride

MM3623.02- H 2N HCl
(2R,5R)-1,6-Diphenylhexane-2,5-diamine Dihydrochloride 1247119-31-8 25mg NH2
2
0025

O
+
N
O O
MM1034.23 4-Nitrophenyl Thiazol-5-ylmethyl Carbonate 144163-97-3 100mg O O
S

O
+
N
MM1034.23- O O
4-Nitrophenyl Thiazol-5-ylmethyl Carbonate 144163-97-3 25mg S
O O
0025 N

MM1034.30- 1-[2-(1-Methylethyl)thiazol-4-yl]-N-methylmethanamine N H HCl


1185167-55-8 25mg S
N 2
0025 Dihydrochloride
NH2
MM0358.00- OH
Methionine (L-Methionine) 63-68-3 250mg S
0250 O

Cocaine Hydrochloride
N H O
O HCl
MM1345.00-
Cocaine Hydrochloride 53-21-4 CS 250mg H O
0250
O

N H O

OH HCl
MM1345.02 Ecgonine Hydrochloride 5796-31-6 CS 100mg
H OH

N H O
MM1345.02- OH HCl
Ecgonine Hydrochloride 5796-31-6 CS 25mg
0025 H OH

N H O

OH
MM1345.04-
Benzoylecgonine 519-09-5 CS 25mg H O
0025
O

N H O
MM1345.08- O
Ecgonine Ethyl Ester 70939-97-8 CS 100mg
0100
H OH

Codeine Monohydrate
N

MM0004.00 Codeine Monohydrate 6059-47-8 CS 100mg H H2O

O O OH

N
OH
HO

MM0442.00 Codeine Phosphate Hemihydrate 41444-62-6 CS 100mg H


O
P
OH
2
H2O

O O OH
2

MM0004.10 Codeine Anhydrate 76-57-3 CS 100mg H

O O OH

N
Impurity A (EP): 7,8-Didehydro-4,5 -epoxy-
H
MM0004.03 3,6 -dimethoxy-17-methylmorphinan 2859-16-7 CS 100mg
(O-Methylcodeine) O
O O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-151
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0004.03- Impurity A (EP): 7,8-Didehydro-4,5 -epoxy-


H
3,6 -dimethoxy-17-methylmorphinan 2859-16-7 CS 25mg
0025
(O-Methylcodeine) O
O O

Impurity B (EP) as Hydrochloride Trihydrate: H HCl H 2O


MM0037.00 6055-06-7 CS 250mg 3

Morphine Hydrochloride Trihydrate HO O OH

Impurity B (EP) as Hemisulphate Pentahemi- N


O

MM0280.00 hydrate: Morphine Hemisulphate Pentahemi- 6211-15-0 CS 250mg H HO S O H


O
H2O
5

hydrate HO O OH
2

Impurity C (EP): 7,7',8,8'-Tetradehydro- HO O O


N

MM0037.02 4,5 :4',5' -diepoxy-3,3'-dimethoxy-17,17'- 121395-47-9 100mg H


O
O OH

dimethyl-2,2'-bimorphinanyl-6 ,6' -diol N

Impurity C (EP): 7,7',8,8'-Tetradehydro- HO O O


N

MM0037.02- H

4,5 :4',5' -diepoxy-3,3'-dimethoxy-17,17'- 121395-47-9 25mg H


O
0025 O OH

dimethyl-2,2'-bimorphinanyl-6 ,6' -diol N

HO N
Impurity E (EP) as -Isomer: 7,8-Didehydro-4,5 -epoxy-3-
MM0004.22- H
methoxy-17-methylmorphinan-6 ,10 -diol (10 - 16589-96-1 25mg
0025
Hydroxycodeine) O
O OH

N
Impurity F (EP): 7,8-Didehydro-4,5 -epoxy-3-
HO
MM0004.12 methoxy-17-methylmorphinan-6 ,14-diol 4829-46-3 100mg
(14-Hydroxycodeine)
O O OH

MM0004.12- Impurity F (EP): 7,8-Didehydro-4,5 -epoxy-3-


HO
methoxy-17-methylmorphinan-6 ,14-diol 4829-46-3 25mg
0025
(14-Hydroxycodeine)
O O OH

H
N

Impurity H (EP): 4,5 -Epoxy-3-methoxy-7,8- H


MM0004.05 467-15-2 CS 100mg
didehydromorphinan-6 -ol (Norcodeine)
O O OH

H
N

MM0004.05- Impurity H (EP): 4,5 -Epoxy-3-methoxy-7,8- H


467-15-2 CS 25mg
0025 didehydromorphinan-6 -ol (Norcodeine)
O O OH

Impurity I (EP): 4,5 -Epoxy-3-methoxy-17-methyl-7,8- H


MM0004.02 467-13-0 100mg
didehydromorphinan-6-one (Codeinone)
O O O

MM0004.02- Impurity I (EP): 4,5 -Epoxy-3-methoxy-17-methyl-7,8- H


467-13-0 25mg
0025 didehydromorphinan-6-one (Codeinone)
O O O

O
+
N

MM0004.01 Codeine N-Oxide 3688-65-1 CS 250mg H

O O OH

N
Impurity K (EP): 4,5 -Epoxy-14-hydroxy-3-methoxy-17-
MM0672.04- HO
methyl-7,8-didehydromorphinan-6-one (14- 508-54-3 25mg
0025
Hydroxycodeinone) O
O O

Impurity L (EP): 4,5 -Epoxy-6-methoxy-17-methyl-6,7,8,14-


MM0037.13 467-04-9 CS 100mg
tetradehydromorphinan-3-ol (Oripavine)
HO O O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-152
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0037.13- Impurity L (EP): 4,5 -Epoxy-6-methoxy-17-methyl-6,7,8,14-


467-04-9 CS 25mg
0025 tetradehydromorphinan-3-ol (Oripavine)
HO O O

N
MM0004.04- H
Codeimethine 23950-06-3 25mg
0025
O O OH

H
MM0004.06 Acetylcodeine 6703-27-1 CS 100mg
O
O O O

MM0004.06- H
Acetylcodeine 6703-27-1 CS 25mg
0025 O
O O O

N
OH

MM0004.07 Pseudocodeine 466-96-6 100mg H

O O

N
OH
MM0004.07-
Pseudocodeine 466-96-6 25mg H

0025
O O

MM0004.08 Isocodeine 509-64-8 CS 100mg H

O O OH

MM0004.08-
Isocodeine 509-64-8 CS 25mg H

0025
O O OH

N
HO O OH
H

MM0037.01 Pseudomorphine 125-24-6 100mg H


O
HO OH
N

N
HO O OH
MM0037.01- H

Pseudomorphine 125-24-6 25mg H


O
HO OH
0025 N

Colchicine
O
H
N
O
MM1083.00 Colchicine 64-86-8 100mg O
O

O
Impurity C (EP): N-[(7S,7bR,10aS)-1,2,3,9-Tetramethoxy-8- H
N

MM1083.03- oxo-5,6,7,7b,8,10a-hexahydrobenzo[a]cyclopenta[3,4] O
O
H
O
6901-13-9 25mg H
0025 cyclobuta[1,2-c]cyclohepten-7-yl]acetamide ( - O

Lumicolchicine) O

HO
O

Impurity D (EP): N-[(7S,12aRa)-3-( -D-Glucopyranosyl- HO


O
O
N
H

MM1083.04 oxy)-1,2,10-trimethoxy-9-oxo-5,6,7,9-tetrahydro- 477-29-2 100mg HO O HO


O

benzo[a]heptalen-7-yl]acetamide (Colchicoside)
O

HO
H
Impurity E (EP): N-[(7S,12aRa)-3-Hydroxy-1,2,10-trimethoxy- O
N

MM1083.05 9-oxo-5,6,7,9-tetrahydrobenzo[a]heptalen-7-yl]acetamide (3- 7336-33-6 100mg O


O

O
O-Demethylcolchicine) O

O
H
Impurity F (EP): N-[(7S,12aRa)-10-Hydroxy-1,2,3-trimethoxy- O
N

MM1083.06 9-oxo-5,6,7,9-tetrahydrobenzo[a]heptalen-7-yl]acetamide 477-27-0 50mg O


O

O
(Colchiceine) OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-153
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Conivaptan Hydrochloride
O

MM3580.00 Conivaptan Hydrochloride 168626-94-6 250mg O

N
H
N

N
H
N HCl

Cortisone
O
OH
O OH

MM0214.00 Cortisone 53-06-5 500mg H

H H
O

Cortisone Acetate
O
O
O
MM0186.00- O OH
Cortisone Acetate 50-04-4 250mg H

0250 H H
O

O
O
O
MM0187.00- HO OH
Impurity A (EP): Hydrocortisone Acetate 50-03-3 250mg H

0250 H H
O

O
OH
HO O
MM0187.01- H
Hydrocortisone 17-Acetate 16463-74-4 25mg O
0025 H H
O

Coumatetralyl
OH

MM3018.00 Coumatetralyl 5836-29-3 100mg


O O

Creatine Monohydrate
O
N NH2
MM3357.01 Creatine 57-00-1 250mg HO
NH

Crizotinib
N NH2

O Cl
MM3930.00- HN N
Crizotinib 877399-52-5 250mg N

0250 Cl
F

Cromolyn Sodium, see Sodium Cromoglicate

Cyanocobalamin
H2 N
H 2N
O
O
H2 N
O
H
O NH H H
O O H (IV)N
P C
O (IV)
N
O OH N

Cyanocobalamin (Vitamin B12)


+ (VI)
Co N H2
HO (IV)
N
MM1449.00 68-19-9 250mg O N
N
(IV) N
(IV)
O
H
H
O

O H 2N
NH2

N
MM1449.01-
5,6-Dimethylbenzimidazole 582-60-5 25mg
0025 N
H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-154
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cyclandelate
OH
O

MM0497.00 Cyclandelate 456-59-7 250mg O

Cyclizine Hydrochloride
N
N

MM1265.00 Cyclizine Hydrochloride 303-25-3 250mg HCl

Impurity A (EP): 1-Methylpiperazine HN


MM1265.01
Related compound A (USP): 1-methylpiperazine
109-01-3 100mg
N

OH

MM0490.02 Impurity B (EP): Diphenylmethanol (Benzhydrol) 91-01-0 100mg

OH
MM0490.02-
Impurity B (EP): Diphenylmethanol (Benzhydrol) 91-01-0 25mg
0025

O
+
N
N
HCl
MM1265.04 Cyclizine N-Oxide Dihydrochloride n/a 100mg 2

O
+
N
MM1265.04- N
HCl
Cyclizine N-Oxide Dihydrochloride n/a 25mg 2
0025

Cyclobenzaprine Hydrochloride
HCl

MM0062.02- N
Cyclobenzaprine Hydrochloride 6202-23-9 250mg
0250

5-[3-(Dimethylamino)propyl]-5H-dibenzo[a,d]cyclohepten-5-ol OH
N
MM1248.01 Related compound A (USP): 5-[3-(dimethylamino)propyl]-5H- 18029-54-4 50mg
dibenzo[a,d]-cyclohepten-5-ol

+
N HCl
MM1248.03 Cyclobenzaprine N-Oxide Hydrochloride n/a 100mg O

Cyclofenil

MM3024.00 Cyclofenil 2624-43-3 250mg O O

O O

Cycloguanil Embonate
Cl

N N

H2 N N NH2
2
MM3025.00 Cycloguanil Embonate 609-78-9 50mg O OH OH O

HO OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-155
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH

OH

MM0893.01 Pamoic Acid 130-85-8 100mg


HO

HO

H
H 2N N
MM0056.01 Cyanoguanidine 461-58-5 100mg N
NH

H
MM0056.01- H 2N N
Cyanoguanidine 461-58-5 25mg N
0025 NH

Cycloguanil Hydrochloride
Cl

MM1580.00 Cycloguanil Hydrochloride 152-53-4 100mg N N HCl

H 2N N N H2

H
H 2N N
MM0056.01 Cyanoguanidine 461-58-5 100mg N
NH

H
MM0056.01- H 2N N
Cyanoguanidine 461-58-5 25mg N
0025 NH

Cyclopentobarbital
H
O N O

NH
MM1579.00 Cyclopentobarbital 76-68-6 50mg
O

Cyclopentolate Hydrochloride
O
N

MM0580.00 Cyclopentolate Hydrochloride 5870-29-1 500mg HO


O HCl

Impurity A (EP): (2RS)-(1-Hydroxycyclopentyl)- OH


MM0580.01 25209-52-3 100mg HO
(phenyl)acetic Acid

MM0580.01- Impurity A (EP): (2RS)-(1-Hydroxycyclopentyl)- OH


25209-52-3 25mg HO
0025 (phenyl)acetic Acid

O
MM0160.03 Impurity B (EP): Phenylacetic Acid 103-82-2 100mg
OH

MM0160.03- O
Impurity B (EP): Phenylacetic Acid 103-82-2 25mg
0025 OH

Impurity C (EP) as Hydrochloride: 2-(Dimethyl- O


MM0580.03 113079-81-5 100mg N HCl
amino)ethyl Phenylacetate Hydrochloride O

MM0580.03- Impurity C (EP) as Hydrochloride: 2-(Dimethyl- O


113079-81-5 25mg N HCl
0025 amino)ethyl Phenylacetate Hydrochloride O

O O
+
N
O HCl
MM0580.05 Cyclopentolate N-Oxide Hydrochloride n/a 100mg HO

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-156
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O O
+
MM0580.05- N
O HCl
Cyclopentolate N-Oxide Hydrochloride n/a 25mg HO

0025

Cyclophosphamide
Cl
O
O
MM0822.00 Cyclophosphamide Monohydrate 6055-19-2 250mg P
NH
N H2 O

Cl

Impurity E (EP) as Dihydrochloride: 3-[2-(2-


O
Chloroethylamino)ethylamino]propyl Dihydrogen Phosphate O
P OH
OH
MM0822.04 Dihydrochloride 158401-51-5 100mg HN Cl
HCl
2

Related compound D (USP): 3-[2-(2-chloroethylamino) N


H

ethylamino]propyl dihydrogen phosphate


Impurity E (EP) as Dihydrochloride: 3-[2-(2-
O

MM0822.04- Chloroethylamino)ethylamino]propyl Dihydrogen Phosphate O


P OH
OH
Dihydrochloride 158401-51-5 25mg HN Cl
HCl
2

0025 Related compound D (USP): 3-[2-(2-chloroethylamino) N


H

ethylamino]propyl dihydrogen phosphate


O
O
Impurity F (EP): 3-Aminopropyl Dihydrogen Phosphate P OH
MM0822.03 Related compound C (USP): 3-aminopropyl dihydrogen 1071-28-9 100mg OH
phosphate
NH2

O
O
Impurity F (EP): 3-Aminopropyl Dihydrogen Phosphate P OH
MM0822.03-
Related compound C (USP): 3-aminopropyl dihydrogen 1071-28-9 25mg OH
0025 phosphate
NH2

MM1352.01 Impurity G (EP): 3-Aminopropanol (Propanolamine) 156-87-6 100mg H 2N OH

Cycloserine
O

MM3028.00 Cycloserine 68-41-7 250mg HN N H2

Cyclosporine, see Ciclosporin

Cyclothiazide
O O O O
S S
H2 N NH

MM3047.00 Cyclothiazide 2259-96-3 100mg Cl N


H

Cynarine
O
MM0048.01- HO
3,4-Dihydroxycinnamic Acid (Caffeic Acid) 331-39-5 250mg OH

0250 HO

Cyproheptadine Hydrochloride
N
H2 O
Cyproheptadine Hydrochloride 3

MM0609.00
Sesquihydrate
41354-29-4 500mg HCl
2
2

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-157
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP): 5H-Dibenzo[a,d][7]annulene


MM0609.01 (Dibenzocycloheptene) 256-81-5 50mg
Related compound A (USP): 5H-dibenzo[a,d]cycloheptene

Impurity B (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]-


MM0062.01 1210-35-1 100mg
annulen-5-one (Dibenzosuberone)

Impurity C (EP) as Hydrochloride: 5-(1-Methyl-


piperidin-4-yl)-5H-dibenzo[a,d][7]annulen-5- OH
N

HCl
MM0609.07 ol Hydrochloride 4046-24-6 50mg
Related compound C (USP): 5-(1-methyl-piperidin-4-yl)-5H-
dibenzo[a,d]cyclohepten-5-ol
O

5H-Dibenzo[a,d]cyclohepten-5-one
MM0609.02
(Dibenzosuberenone)
2222-33-5 100mg

O
MM0609.02- 5H-Dibenzo[a,d]cyclohepten-5-one
(Dibenzosuberenone)
2222-33-5 25mg
0025

NH

MM0609.04- HCl
Demethylcyproheptadine Hydrochloride 4331-45-7 25mg
0025

+
N
O

MM0609.05 Cyproheptadine -N-Oxide 54381-42-9 100mg


alpha-Isomer

+
N
O

MM0609.06 Cyproheptadine -N-Oxide 60251-34-5 100mg


beta-Isomer

+
N
O
MM0609.06-
Cyproheptadine -N-Oxide 60251-34-5 25mg
0025 beta-Isomer

Cyproterone Acetate
O

O
H
MM0215.00 Cyproterone Acetate 427-51-0 250mg H H
O

O
Cl

Impurity I (EP): 6-Chloro-3,20-dioxopregna-1,4,6-trien-17-yl O


H
MM0529.07 Acetate (Delmadinone Acetate; 1,2-Didehydrochlormadinone 13698-49-2 100mg H H
O

Acetate) O
Cl

Impurity I (EP): 6-Chloro-3,20-dioxopregna-1,4,6-trien-17-yl O


MM0529.07- H
Acetate (Delmadinone Acetate; 1,2-Didehydrochlormadinone 13698-49-2 25mg H H
O

0025 Acetate) O
Cl

Cytarabine
OH
HO

MM1117.00 Cytarabine 147-94-4 250mg N O OH

H 2N N O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-158
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HN

Impurity A (EP): 1- -D-Arabinofuranosylpyrimidine-2,4 O N


MM1117.03 3083-77-0 100mg
(1H,3H)-dione (Uracil Arabinoside) OH
O

HO OH

HN

MM1117.03- Impurity A (EP): 1- -D-Arabinofuranosylpyrimidine-2,4 O N


3083-77-0 25mg
0025 (1H,3H)-dione (Uracil Arabinoside) OH
O

HO OH

HN

Impurity B (EP): 1- -D-Ribofuranosylpyrimidine-2,4(1H,3H)- HO O N


MM0784.02 58-96-8 100mg O
dione (Uridine)

O HO H

HN

MM0784.02- Impurity B (EP): 1- -D-Ribofuranosylpyrimidine-2,4(1H,3H)- HO O N


58-96-8 25mg O
0025 dione (Uridine)

O HO H

NH2

MM0749.05- N
Impurity C (EP): 4-Aminopyrimidin-2(1H)-one (Cytosine) 71-30-7 25mg
0025
O N
H

MM0593.03- HN
Impurity D (EP): Pyrimidin-2,4(1H,3H)-dione (Uracil) 66-22-8 25mg
0025
O N
H

N H2

Impurity E (EP): 4-Amino-1- -D-ribofuranosylpyrimidin-2(1H)- O N


MM1316.01 65-46-3 100mg
one (Cytidine) OH
O

HO OH

DDT
Cl

MM2513.01 2,2-Bis(4-chlorophenyl)-1-chloroethane 2642-80-0 100mg


Cl Cl

Cl

MM2513.01-
2,2-Bis(4-chlorophenyl)-1-chloroethane 2642-80-0 25mg
0025 Cl Cl

Cl
MM2513.02 1-Chloro-3-[1-(4-chlorophenyl)ethyl]benzene 77008-64-1 100mg
Cl

MM2513.05 1,1-Bis(4-chlorophenyl)ethane 3547-04-4 100mg


Cl Cl

MM2513.05-
1,1-Bis(4-chlorophenyl)ethane 3547-04-4 25mg
0025 Cl Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-159
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Dabigatran Etexilate Mesilate


O
NH
H

Dabigatran Etexilate Mesilate


N N O
N N O O
N
H S
N O OH
MM3522.00 872728-81-9 100mg O O

O
Ethyl 3-[[3-Amino-4-(methylamino)benzoyl]-(2-pyridyl)amino] NH2
N N
MM3522.01 propanoate (N-[3-Amino-4-(methylamino)benzoyl]-N-2- 212322-56-0 100mg NH

pyridinyl- -alanine Ethyl Ester) O O

O
Ethyl 3-[[3-Amino-4-(methylamino)benzoyl]-(2-pyridyl)amino] NH2
MM3522.01- N N
propanoate (N-[3-Amino-4-(methylamino)benzoyl]-N-2- 212322-56-0 25mg NH
0025
pyridinyl- -alanine Ethyl Ester) O O

O
NH
H
MM3522.02- N N
N N
N H2
Dabigatran 211914-51-1 25mg N

0025 O OH

Dabigatran Etexilate Amid Analogon (Ethyl 3-[[2-[[4-


O
O
H
MM3522.04- (Hexoxycarbonylcarbamoyl)anilino]methyl]-1- N N
N N
N
O

H
1408238-40-3 25mg N O

O O
0025 methylbenzimidazole-5-carbonyl]-(2-pyridyl)amino]
propanoate)
NH
H2 N O
Hexyl N-(4-Aminobenzenecarboximidoyl)carbamate N
H HCl
MM3522.06 1307233-93-7 100mg O

Hydrochloride
NH
H2 N O
MM3522.06- Hexyl N-(4-Aminobenzenecarboximidoyl)carbamate N
H HCl
1307233-93-7 25mg O

0025 Hydrochloride
O
NH
H
MM3522.08- N N
N N
N
O

H
Desethyldabigatran Etexilate 212321-78-3 25mg N O

O OH
0025
O
H
MM3522.09- Ethyl 3-[[2-[(4-Cyanoanilino)methyl]-1-methylbenzimidazole- N N N
N N

211915-84-3 25mg N

0025 5-carbonyl]-(2-pyridyl)amino]propanoate O O

O O
+
N
MM3522.10- Ethyl 3-[[4-(Methylamino)-3-nitrobenzoyl]-(2-pyridyl)amino] N N O
429659-01-8 25mg NH
0025 propanoate
O O

Dacarbazine
N
HN
N H2

MM1289.00 Dacarbazine 4342-03-4 100mg N


N O

Impurity A (EP) as Monohydrate: 3,7-Dihydro-4H-imidazo


N
[4,5-d]-1,2,3-triazin-4-one Monohydrate (2-Azahypoxanthine HN
O
MM1289.05 Monohydrate) 7151-03-3 100mg H2 O
N NH
N

Related compound B (USP): 2-azahypoxanthine


Impurity A (EP) as Monohydrate: 3,7-Dihydro-4H-imidazo
N
MM1289.05- [4,5-d]-1,2,3-triazin-4-one Monohydrate (2-Azahypoxanthine HN
O
Monohydrate) 7151-03-3 25mg H2 O

0025 N NH
N

Related compound B (USP): 2-azahypoxanthine


N
Impurity B (EP): 5-Amino-1H-imidazole-4-carboxamide HN
N H2
MM1289.02 Related compound A (USP): 5-aminoimidazole-4- 360-97-4 100mg
carboxamide H 2N O

N
Impurity B (EP): 5-Amino-1H-imidazole-4-carboxamide HN
MM1289.02- N H2
Related compound A (USP): 5-aminoimidazole-4- 360-97-4 25mg
carboxamide
0025 H 2N O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-160
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity B (EP) as Hydrochloride: 5-Amino-1H-imidazole-4-


N
MM1289.06- carboxamide Hydrochloride HN
N H 2 HCl
72-40-2 25mg
0025 Related compound A (USP): 5-aminoimidazole-4- H 2N O

carboxamide
Impurity D (EP) as Hydrochloride: N-Methylmethanamine H
MM0056.06 506-59-2 100mg N HCl
Hydrochloride

Daidzein
HO O

MM0747.02 (RS)-Equol 94105-90-5 100mg


OH

HO O

MM0747.02-
(RS)-Equol 94105-90-5 25mg
0025 OH

Dalfampridine

N
MM3462.00 Dalfampridine 504-24-5 100mg
NH2

Danofloxacin Mesilate
O O
F
H OH

MM3710.00 Danofloxacin Mesilate 119478-55-6 250mg N


H
N N O O
S
OH

Dantrolene Sodium
5-(4-Nitrophenyl)furan-2-carbaldehyde O
O
MM0905.01 Related compound C (USP): (5-(4-nitrophenyl)-2- 7147-77-5 100mg O +
N
O
furancarboxyaldehyde
5-(4-Nitrophenyl)furan-2-carbaldehyde O
MM0905.01- O
Related compound C (USP): (5-(4-nitrophenyl)-2- 7147-77-5 25mg O +
N
0025 O
furancarboxyaldehyde
5-(4-Nitrophenyl)-2-furaldehyde Azine O
N
+
O
N
+
O
O

MM0905.03 Related compound A (USP): 1,2-Bis[5-(4-nitrophenyl)furan-2-yl] 301359-05-7 100mg O


O
N

methylenehydrazine N

MM0905.03- 5-(4-Nitrophenyl)-2-furaldehyde Azine O


N
+
O
N
+
O
O

Related compound A (USP): 1,2-Bis[5-(4-nitrophenyl)furan-2-yl] 301359-05-7 25mg O


O
N
0025 methylenehydrazine N

Dantrolene Sodium Hydrate


O +
Na
N
2

Dantrolene Sodium Hydrate


O N
N
O +
MM3086.00 24868-20-0 250mg N
O
O
H2O
7
2

Dapagliflozin (2S)-1,2-Propanediol Monohydrate


O

H2 O
Cl

MM3611.00 Dapagliflozin (2S)-1,2-Propanediol Monohydrate 960404-48-2 50mg OH


O
OH

HO OH
OH
OH

Cl
OH
MM3611.04 Dapagliflozin 461432-26-8 100mg O

HO OH
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-161
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM3611.01 4-Bromo-1-chloro-2-(4-ethoxybenzyl)benzene 461432-23-5 100mg Cl

Br

MM3611.01-
4-Bromo-1-chloro-2-(4-ethoxybenzyl)benzene 461432-23-5 25mg Cl
0025
Br

Dapagliflozin Tetraacetate ([(2R,3R,4R,5S,6S)-3,4,5- O O


Cl

O
MM3611.02 Triacetoxy-6-[4-chloro-3-(4-ethoxybenzyl)phenyl] 461432-25-7 100mg
O O O

tetrahydropyran-2-yl]methyl Acetate) O
O
O

Dapagliflozin Tetraacetate ([(2R,3R,4R,5S,6S)-3,4,5- O O


Cl
MM3611.02- O
Triacetoxy-6-[4-chloro-3-(4-ethoxybenzyl)phenyl] 461432-25-7 25mg
0025 O O O

tetrahydropyran-2-yl]methyl Acetate) O
O
O

MM3611.03- (2S,3R,4S,5S,6R)-2-[4-Chloro-3-(4-ethoxybenzyl)phenyl]-6- Cl
OH
714269-57-5 25mg O
O
0025 (hydroxymethyl)-2-methoxy-tetrahydropyran-3,4,5-triol
HO OH
OH

Dapoxetine Hydrochloride
O N

MM3523.00 Dapoxetine Hydrochloride 129938-20-1 250mg HCl

O OH

MM3523.01 (1R)-3-(1-Naphthyloxy)-1-phenylpropan-1-ol 156453-53-1 100mg

O OH
MM3523.01-
(1R)-3-(1-Naphthyloxy)-1-phenylpropan-1-ol 156453-53-1 25mg
0025

Dapsone
H2 N NH2

MM1932.00 Dapsone 80-08-0 250mg S


O O

Darifenacin Hydrobromide
O

N
MM3525.00 Darifenacin Hydrobromide 133099-07-7 250mg HBr

N H2

Darunavir Ethanolate
H O O O O
MM3624.00-
Darunavir Ethanolate 635728-49-3 250mg O
H
O N
H
OH
N
S

NH2
0250 OH

MM3624.01- O
tert-Butyl N-((1S)-1-Benzyl-3-chloro-2-oxopropyl)carbamate 102123-74-0 25mg
0025 O N Cl
H
O

O
H O O
MM3624.02- [(3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-yl] (2,5-
253265-97-3 25mg O N
O O
0025 Dioxopyrrolidin-1-yl) Carbonate H O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-162
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM3624.03- N-[(2R,3S)-3-Amino-2-hydroxy-4-phenylbutyl]-N-(2- O O
S HCl
244634-31-9 25mg H 2N N
OH + O
0025 methylpropyl)-4-nitrobenzenesulfonamide Hydrochloride N
O

O O O
MM3624.04- tert-Butyl N-[(1S,2R)-1-Benzyl-2-hydroxy-3-[(2-methylpropyl) S
191226-98-9 25mg O N N
H
OH +O
0025 [(4-nitrophenyl)sulfonyl]amino]propyl]carbamate N
O

O
MM3624.05- tert-Butyl N-[(1S,2R)-1-Benzyl-2-hydroxy-3-[(2-methylpropyl)
160232-08-6 25mg O N NH
H
0025 amino]propyl]carbamate OH

O O
MM3624.06- 4-Amino-N-((2R,3S)-3-amino-2-hydroxy-4-phenylbutyl)-N-(2- S
169280-56-2 25mg H 2N N

0025 methylpropyl)benzenesulfonamide OH
N H2

MM3624.07- tert-Butyl N-[(1S)-1-((2S)-Oxiran-2-yl)-2-phenylethyl] O


98737-29-2 25mg
0025 carbamate O N
H O

4-Nitrophenyl (2S)-2-(tert-Butoxycarbonylamino)-3- O
MM3624.08- O
phenylpropanoate (N-BOC-L-Phenylalanine 4-Nitrophenyl 7535-56-0 25mg O N
H
O +O
0025 N
Ester) O

NH2
OH
MM1560.00 Phenylalanine (L-Phenylalanine) 63-91-2 250mg
O

MM3624.15- HCl
(2S,3S)-3-Amino-1-chloro-4-phenylbutan-2-ol Hydrochloride 166987-16-2 25mg
0025 H 2N Cl
OH

Dasatinib Monohydrate
N
MM3451.00- N
N

Dasatinib Monohydrate 863127-77-9 250mg HO


N

N
H
N

S
H
N
Cl H2O

O
0250
N
O
MM3451.01- + N
N N
N Cl
HO H
Dasatinib N-Oxide 910297-52-8 25mg N N
H S

0025 O

N
N
MM3451.02- N-(2-Chloro-6-methylphenyl)-2-[(6-chloro-2-methylpyrimidin- Cl
N Cl
H
302964-08-5 25mg N N
H S
0025 4-yl)amino]thiazole-5-carboxamide O

N N

MM3451.03 2-[4-(6-Chloro-2-methylpyrimidin-4-yl)piperazin-1-yl]ethanol 127116-19-2 100mg N Cl


N
HO

MM3451.03- N N

2-[4-(6-Chloro-2-methylpyrimidin-4-yl)piperazin-1-yl]ethanol 127116-19-2 25mg N Cl


0025 HO
N

Cl
MM3451.04- H 2N
2-Chloro-6-methylaniline 87-63-8 100mg
0100

MM3451.05- N N
4,6-Dichloro-2-methylpyrimidine 1780-26-3 25mg
0025
Cl Cl

N Cl
H
MM3451.06- H 2N N
S
2-Amino-N-(2-chloro-6-methylphenyl)thiazole-5-carboxamide 302964-24-5 25mg
0025 O

Cl
H
MM3451.07- O N
(2E)-N-(2-Chloro-6-methylphenyl)-3-ethoxyprop-2-enamide 863127-76-8 25mg O
0025

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-163
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cl Cl
MM3451.11-
3,4-Dichloro-5-hydroxy-2(5H)-furanone 766-40-5 25mg
0025 O O OH

OH
MM0182.05- N
1-(2-Hydroxyethyl)piperazine 103-76-4 100mg HN
0100

Daunorubicin Hydrochloride
O OH O

OH

MM0284.00 Daunorubicin Hydrochloride 23541-50-6 250mg O O OH


O
O HCl

NH2
OH

O OH O
OH
OH

MM0283.00 Impurity D (EP) as Hydrochloride: Doxorubicin Hydrochloride 25316-40-9 100mg O O OH


O
O HCl

NH2
OH

Deanol Acetamidobenzoate
O
OH
N

MM1681.00 Deanol Acetamidobenzoate 3635-74-3 100mg O

N
OH

OH
N
MM1681.02 Deanol 108-01-0 100mg

+ OH
N
MM1681.01 Deanol N-Oxide 10489-99-3 100mg
O

Debrisoquin Sulfate
NH
O O

MM0594.00 Debrisoquin Sulfate 581-88-4 100mg N NH2


HO
S
OH
2

Decamethonium Iodide

Decamethonium Iodide
+
+ N I
N
MM3044.00 1420-40-2 250mg 2

Decitabine
N H2

N N

N O
MM3526.00 Decitabine 2353-33-5 250mg
O

HO OH

O
MM0250.05- Methyl 4-Chlorobenzoate O
1126-46-1 25mg
0025 Related compound D (USP)
Cl

Decoquinate
O N

MM3043.00 Decoquinate 18507-89-6 100mg O


OH O
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-164
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Deferasirox
O

OH

N
MM3527.00 Deferasirox 201530-41-8 250mg N
N

OH
HO

OH H O
H
N
MM3527.01 Disalicylamide 1972-71-0 100mg
O O

OH H O
MM3527.01- H
N
Disalicylamide 1972-71-0 25mg
0025 O O

MM3527.02- OH
4-Hydrazinobenzoic Acid 619-67-0 25mg H 2N
0025 N
H

MM3527.03- N OH
2-(2-Hydroxyphenyl)-4H-1,3-benzoxazin-4-one 1218-69-5 25mg
0025 O

MM0045.00- OH
Salicylic Acid 69-72-7 250mg
0250
OH

MM1939.00 Salicylamide 65-45-2 250mg NH2

OH

Deferiprone
O

MM0975.01 Impurity B (EP): 3-Hydroxy-2-methyl-4H-pyran-4-one (Maltol) 118-71-8 250mg


OH
O

Deflazacort
O

O
MM1224.00- N
Deflazacort 14484-47-0 250mg HO
O
0250 H
H
H H
O

O
N
HO
H O
MM1224.01 21-Desacetoxydeflazacort 13649-88-2 100mg H
H H
O

O
N
HO
MM1224.01- H O
21-Desacetoxydeflazacort 13649-88-2 25mg H
0025 H H
O

HO

21-Desacetyldeflazacort O
N
HO
O
MM1224.02 Related compound C (USP): 11Beta,21-Dihydroxy-2'-methyl- 13649-57-5 100mg H
H
H H
5'BetaH-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione O

HO

21-Desacetyldeflazacort O
N
MM1224.02- HO
O
Related compound C (USP): 11Beta,21-Dihydroxy-2'-methyl- 13649-57-5 25mg H
0025 H
H H
5'BetaH-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-165
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Delorazepam
H O
N

Cl N
MM1371.00 Delorazepam 2894-67-9 CS 100mg
Cl

Dembrexine Hydrochloride Monohydrate


O

OH
MM1200.03 Impurity C (EP): 3,5-Dibromo-2-hydroxybenzaldehyde 90-59-5 100mg
Br Br

MM1200.03- OH
Impurity C (EP): 3,5-Dibromo-2-hydroxybenzaldehyde 90-59-5 25mg
0025
Br Br

Impurity D (EP): 2-Hydroxybenzaldehyde OH


MM1200.04 90-02-8 100mg
(Salicylaldehyde)

Br
OH
MM1200.05 Impurity E (EP): 2,4,6-Tribromophenol 118-79-6 100mg
Br Br

Br
MM1200.05- OH
Impurity E (EP): 2,4,6-Tribromophenol 118-79-6 25mg
0025
Br Br

Demecarium Bromide
+
N
N O

MM3042.00 Demecarium Bromide 56-94-0 100mg O


O

N
O

N
+
Br
2

Demeclocycline Hydrochloride
OH O OH O O
OH
NH2

MM0636.00 Demeclocycline Hydrochloride 64-73-3 250mg H H


OH
Cl OH N HCl

Impurity B (EP) as Hydrochloride: (4R,4aS,5aS,6S,12aS)-7-


OH O OH O O
Chloro-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-1,11- OH
N H2

MM0636.01 dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2- 179471-95-5 50mg H H


OH
HCl
carboxamide Hydrochloride (4-Epidemeclocycline Cl OH N

Hydrochloride; 4-Epidemethylchlortetracycline Hydrochloride)


OH O OH O O
OH
N H2

MM0607.00 Chlortetracycline Hydrochloride 64-72-2 500mg H H


OH
Cl H O N HCl

Dequalinium Chloride
H 2N
Cl

Dequalinium Chloride
+
N +
N
MM1705.00 522-51-0 100mg Cl
N H2

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-166
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Deracoxib
O

F O O
S
NH2

MM3693.00 Deracoxib 169590-41-4 250mg N


N
F
F

Desipramine Hydrochloride

N N HCl
MM0589.00 Desipramine Hydrochloride 58-28-6 250mg H

MM0077.00- N N HCl
Impurity A (EP) as Hydrochloride: Imipramine Hydrochloride 113-52-0 250mg
0250

NH
MM0076.06 Iminodibenzyl 494-19-9 100mg

MM0076.06- NH
Iminodibenzyl 494-19-9 25mg
0025

Desloratadine
Cl

NH
MM0257.01-
Desloratadine 100643-71-8 250mg
0250 N

Cl

F NH
MM3528.01- Impurity A (EP): (11RS)-8-Chloro-11-fluoro-11-(piperidin-4-
298220-99-2 25mg
0025 yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
N

O
Cl

MM0257.00- Impurity C (EP): Ethyl 4-(8-chloro-5,6-dihydro-11H-benzo N O

[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine-1- 79794-75-5 250mg


N
0250 carboxylate (Loratadine)

NH
Deschlorodesloratadine Hydrochloride (6,11-Dihydro-11-
HCl
MM0257.19 (piperidin-4-ylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine n/a 100mg N

Hydrochloride)
NH
Deschlorodesloratadine Hydrochloride (6,11-Dihydro-11-
MM0257.19- HCl
(piperidin-4-ylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine n/a 25mg N
0025
Hydrochloride)
Cl
N

8-Chloro-11-(1-methylpiperidin-4-ylidene)-6,11-dihydro-5H-
MM0257.05 38092-89-6 100mg
benzo[5,6]cyclohepta[1,2-b]pyridine N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-167
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cl

MM0257.05- 8-Chloro-11-(1-methylpiperidin-4-ylidene)-6,11-dihydro-5H-
38092-89-6 25mg
0025 benzo[5,6]cyclohepta[1,2-b]pyridine N

O
Cl
N-Formyldesloratadine
N
MM0257.15- Related compound F (USP): 8-Chloro-6,11-dihydro-11-(N-
117810-61-4 25mg
0025 formyl-4-piperidinylidene) -5H-benzo[5,6]cyclohepta[1,2-b] N

pyridine
Cl
N
N O
MM0257.25- N-Nitrosodesloratadine (8-Chloro-6,11-dihydro-11-(1-nitroso-
1246819-22-6 25mg
0025 4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin) N

Desogestrel
OH

MM1024.00-
Desogestrel 54024-22-5 250mg H H

0250 H H

MM1024.05- Impurity C (EP): 13-Ethyl-11-methylidenegon-4-en-17-one


H H
Related compound D (USP): 13-Ethyl-11-methylenegon-4- 54024-21-4 25mg
H
en-17-one
0025 H

OH

MM1024.03- Impurity D (EP): 13-Ethyl-17-hydroxy-11-methylidene-18,19-


H H
dinor-17 -pregn-4-en-20-yn-3-one (3-Ketodesogestrel) 54048-10-1 25mg
H H
0025 Related compound C (USP): 3-Ketodesogestrel O

Desoxycortone Acetate
O O

MM1685.00 Desoxycortone Acetate 56-47-3 250mg H

H H
O

Desvenlafaxine Succinate Monohydrate


O
OH
OH

MM0393.13 Desvenlafaxine Succinate Monohydrate 386750-22-7 100mg N


HO

H2O
O

HO

OH

MM0393.01 Desvenlafaxine (O-Desmethylvenlafaxine) 93413-62-8 100mg N

HO

N,O-Didesmethylvenlafaxine Hydrochloride OH
MM0393.05- H
HCl
Related compound B (USP): 4-[1-(1-Hydroxycyclohexyl)-2- 300827-92-3 25mg N

0025
(methylamino)ethyl]phenol HO

MM0393.15- N
(4-Methoxyphenyl)acetonitrile 104-47-2 100mg
0100 O

MM1275.49- Hordenine Hydrochloride (4-Hydroxy-N,N- N


HCl
6027-23-2 25mg
0025 dimethylphenethylamine Hydrochloride) HO

Detomidine Hydrochloride
H
N

MM1015.00 Detomidine Hydrochloride 90038-01-0 100mg N


HCl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-168
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Dexamethasone
O
OH
HO OH

MM0213.00 Dexamethasone 50-02-2 250mg H

F H
O

Impurity B (EP): 9-Fluoro-11 ,17,21-trihydroxy- HO OH


OH

MM0200.00 16 -methylpregna-1,4-diene-3,20-dione 378-44-9 250mg H

F H
(Betamethasone) O

O
OH
Impurity C (EP): 9-Fluoro-11 ,17,21-trihydroxy- HO
H
OH

MM0213.01 426-17-5 50mg


16 -methylpregn-4-ene-3,20-dione F H
O

O
Impurity D (EP): 9 ,11 -Epoxy-17,21-dihydroxy-16 - OH
OH
O
MM0213.04 methylpregna-1,4-diene-3,20-dione (Dexamethasone 9,11- 24916-90-3 100mg
H H
Epoxide) O

O
Impurity D (EP): 9 ,11 -Epoxy-17,21-dihydroxy-16 - OH
MM0213.04- OH
O
methylpregna-1,4-diene-3,20-dione (Dexamethasone 9,11- 24916-90-3 25mg
0025 H H
Epoxide) O

O
OH
MM0213.05- Impurity E (EP): 17,21-Dihydroxy-16 -methylpregna-1,4,9 OH
H
13209-41-1 25mg
0025 (11)-triene-3,20-dione H
O

O
OH
Impurity F (EP): 9-Fluoro-11 ,21-dihydroxy-16 - HO
H
MM0213.06 382-67-2 100mg
methylpregna-1,4-diene-3,20-dione F H
O

O
O
Impurity G (EP): 9-Fluoro-11 ,17-dihydroxy-16 - HO OH
O

MM0445.00 methyl-3,20-dioxopregna-1,4-dien-21-yl Acetate 1177-87-3 250mg H

(Dexamethasone Acetate) O
F H

O
O
O
Impurity H (EP): 17-Hydroxy-16 -methyl-3,20-dioxopregna- OH
H
MM0445.08 10106-41-9 100mg
1,4,9(11)-trien-21-yl Acetate H
O

O
O
O
MM0445.08- Impurity H (EP): 17-Hydroxy-16 -methyl-3,20-dioxopregna- OH
H
10106-41-9 25mg
0025 1,4,9(11)-trien-21-yl Acetate H
O

O OH
MM0213.13- Impurity J (EP): 17,21-Dihydroxy-16 -methylpregna-1,4- OH
H
2036-77-3 25mg
0025 diene-3,11,20-trione H H
O

O
HO
Dexamethasone-17-ketone (9a-Fluoro-11ß-hydroxy-16a- H
MM0213.10 1880-61-1 100mg F
methylandrosta-1,4-diene-3,17-dione) H
O

O
HO
MM0213.10- Dexamethasone-17-ketone (9a-Fluoro-11ß-hydroxy-16a- H
1880-61-1 25mg F
0025 methylandrosta-1,4-diene-3,17-dione) H
O

O
HO

MM0213.11- HO
(Z)-9-Fluoro-11ß,20-dihydroxy-16a-methylpregna-1,4,17(20)-
1174035-75-6 25mg H
0025 triene-3,21-dione F H
O

O
OH
HO H
MM0213.15- 9-Fluoro-11 -hydroxy-16 -methyl-3-oxoandrosta-1,4-diene- H
75262-69-0 25mg
0025 17 -carboxylic Acid F H
O

O
O
17-Hydroxy-16 -methyl-3,20-dioxo-9 ,11 -epoxypregna-1,4- O
MM0445.06- OH
O
dien-21-yl Acetate (9,11 -Epoxy-17-hydroxy-16 -methyl- 2884-51-7 25mg
0025 H H

3,20-dioxo-9 -pregna-1,4-dien-21-yl Acetate) O

O O

O
HO OH
MM0445.01- 9-Fluoro-11 ,17-dihydroxy-16 -methyl-3,20-dioxopregn-4-en- H
1524-94-3 25mg
0025 21-yl Acetate F H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-169
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O OH
MM0213.17- OH
H
11-Dehydrodexamethasone 2964-81-0 25mg
0025 F H
O

HO

HO OH
MM0213.18- OH
H
20-Dihydrodexamethasone 55879-48-6 25mg
0025 F H
O

O
HO O
MM0213.20- H
Dexamethasone Oxetanone 4089-36-5 25mg
0025 F H
O

OH
HO
MM0200.11- 9-Fluoro-11 ,21-dihydroxy-16-methylpregna-1,4,16-triene- H
59860-99-0 25mg
0025 3,20-dione F H
O

O
O
HO OH
MM0213.22- H
Dexamethasone Acid Ethyl Ester n/a 25mg
0025 F H
O

O
O
O
MM0213.23- HO OH
17 -Carboxy-17 -formyloxydexamethasone 473273-04-0 25mg H
0025 F H
O

O
O
H
MM0213.24- HO OH
H H2 O
21-Dehydrodexamethasone Dihydrate n/a 25mg 2
F H
0025 O

Dexamethasone Acetate
O
O
O
HO OH
MM0445.00 Dexamethasone Acetate 1177-87-3 250mg H

F H
O

Impurity A (EP): 9-Fluoro-11 ,17,21-trihydroxy- HO OH


OH

MM0213.00 16 -methylpregna-1,4-diene-3,20-dione 50-02-2 250mg H

F H
(Dexamethasone) O

O
O
Impurity D (EP): 9-Fluoro-11 ,17-dihydroxy-16 - HO OH
O

MM0201.00 methyl-3,20-dioxopregna-1,4-dien-21-yl Acetate 987-24-6 250mg H

(Betamethasone Acetate) O
F H

O O

O
HO OH
MM0445.01- Impurity E (EP): 9-Fluoro-11 ,17-dihydroxy-16 -methyl-3,20- H
1524-94-3 25mg
0025 dioxopregn-4-en-21-yl Acetate F H
O

O
O
O
MM0445.06- Impurity F (EP): 9,11 -Epoxy-17-hydroxy-16 -methyl-3,20- OH
O
2884-51-7 25mg
0025 dioxo-9 -pregna-1,4-dien-21-yl Acetate H H
O

O
O
O
MM0445.07- Impurity G (EP): 9-Fluoro-11 -hydroxy-16 -methyl-3,20- HO
H
1597-78-0 25mg
0025 dioxopregna-1,4-dien-21-yl Acetate F H
O

O
O
O
Impurity H (EP): 17-Hydroxy-16 -methyl-3,20-dioxopregna- OH
H
MM0445.08 10106-41-9 100mg
1,4,9(11)-trien-21-yl Acetate H
O

O
O
O
MM0445.08- Impurity H (EP): 17-Hydroxy-16 -methyl-3,20-dioxopregna- OH
H
10106-41-9 25mg
0025 1,4,9(11)-trien-21-yl Acetate H
O

O
O O
Impurity I (EP): 9-Fluoro-17-hydroxy-16 -methyl-3,20- O
MM0445.09- O OH
H
dioxopregna-1,4-diene-11 ,21-diyl Diacetate 3949-26-6 25mg
0025 F H

(Dexamethasone 11,21-Diacetate) O

O
HO O
MM0213.20- H
Dexamethasone Oxetanone 4089-36-5 25mg
0025 F H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-170
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
O
H
MM0213.24- HO OH
H H2 O
21-Dehydrodexamethasone Dihydrate n/a 25mg 2
F H
0025 O

O OH
MM0213.13- OH
H
17,21-Dihydroxy-16 -methylpregna-1,4-diene-3,11,20-trione 2036-77-3 25mg
0025 H H
O

O
OH
HO H
MM0213.15- 9-Fluoro-11 -hydroxy-16 -methyl-3-oxoandrosta-1,4-diene- H
75262-69-0 25mg
0025 17 -carboxylic Acid F H
O

Dexamethasone Isonicotinate
O
O
O
MM3804.00- HO OH
N
H
Dexamethasone Isonicotinate 2265-64-7 250mg
0250 F H
O

O
OH
HO OH
Impurity A (EP): A. 9-Fluoro-11 ,17,21-trihydroxy-16 - H
MM0213.00 50-02-2 250mg
methylpregna-1,4-diene-3,20-dione (Dexamethasone) F H
O

O
O
Impurity B (EP): 9-Fluoro-11 ,17-dihydroxy-16 -methyl-3,20- O
HO OH
MM0445.00 H
dioxopregna-1,4-dien-21-yl Acetate (Dexamethasone 1177-87-3 250mg
F H

Acetate) O

O
O
O
MM0445.06- 9,11 -Epoxy-17-hydroxy-16 -methyl-3,20-dioxo-9 -pregna- OH
O
2884-51-7 25mg
0025 1,4-dien-21-yl Acetate H H
O

Dexamethasone Sodium Phosphate


O O +
O Na
O P
HO OH +
O Na

MM0210.00 Dexamethasone Sodium Phosphate 2392-39-4 250mg H

F H
O

O
OH
Impurity A (EP): 9-Fluoro-11 ,17,21-trihydroxy-16 - HO
H
OH

MM0213.00 50-02-2 250mg


methylpregna-1,4-diene-3,20-dione (Dexamethasone) F H
O

+
O O O Na
Impurity B (EP) as Disodium Salt: 9-Fluoro-11 ,17-dihydroxy- O
P
O Na
+
HO OH
H
MM0303.00 16 -methyl-3,20-dioxopregna-1,4-dien-21-yl Disodium 151-73-5 250mg
F H
O
Phosphate (Betamethasone Sodium Phosphate)
O
OH
HO OH
MM0210.07- Impurity G (EP): 9-Fluoro-11 ,17 -dihydroxy-16 -methyl-3- H
37927-01-8 25mg
0025 oxoandrosta-1,4-diene-17 -carboxylic Acid F H
O

O N
MM0210.12- 9-Fluoro-11 ,17-dihydroxy-16 -methyl-3,20-dioxopregna-1,4- HO OH
O P
N
3864-50-4 25mg O
H
O
0025 dien-21-yl Dimorpholinophosphinate F H
O

O
O
17-Hydroxy-16 -methyl-3,20-dioxo-9 ,11 -epoxypregna-1,4- O
MM0445.06- OH
O
dien-21-yl Acetate (9,11 -Epoxy-17-hydroxy-16 -methyl- 2884-51-7 25mg
0025 H H

3,20-dioxo-9 -pregna-1,4-dien-21-yl Acetate) O

O
HO O
MM0213.20- H
Dexamethasone Oxetanone 4089-36-5 25mg
0025 F H
O

O
O
H
MM0213.24- HO OH
H H2 O
21-Dehydrodexamethasone Dihydrate n/a 25mg 2

0025 F H
O

O OH
MM0213.13- OH
H
17,21-Dihydroxy-16 -methylpregna-1,4-diene-3,11,20-trione 2036-77-3 25mg
0025 H H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-171
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
OH
HO H
MM0213.15- 9-Fluoro-11 -hydroxy-16 -methyl-3-oxoandrosta-1,4-diene- H
75262-69-0 25mg
0025 17 -carboxylic Acid F H
O

Dexamethasone Sodium Sulfobenzoate


O O O
O +
S Na
O O
HO

Dexamethasone Sodium Sulfobenzoate


OH
H
MM0861.00 3936-02-5 100mg F H
O

Dexamfetamine Sulfate (Dextroamphetamine Sulfate)


NH2 O
HO S OH
MM1359.00 Dexamfetamine Sulfate (Dextroamphetamine Sulfate) 51-63-8 CS 100mg O
2

Impurity A (EP): (2RS)-1-Phenylpropan-2-ol (1-Phenyl-2- OH


MM0741.03 propanol) 698-87-3 100mg
Related compound A (USP): 1-Phenyl-2-propanol
O
Impurity B (EP): 1-Phenylpropan-2-one (Phenylacetone)
MM0741.04 103-79-7 100mg
Related compound B (USP): Phenyl acetone

Impurity C (EP) as Hydrochloride: (2S)-2-Amino-1- O


MM1360.02- NH2 HCl
phenylpropan-1-one Hydrochloride (Cathinone 72739-14-1 CS 25mg
0025
Hydrochloride)

MM0528.05- O
Impurity D (EP): Benzaldehyde 100-52-7 500mg
0500

NH2
MM0741.00- O O
S
Amfetamine Sulfate 60-13-9 CS 250mg HO OH
0250 2

O
+
MM1359.03- N
[(1E)-2-Nitro-1-propen-1-yl]benzene 18315-84-9 25mg O
0025

Dexchlorpheniramine Maleate
Cl
O

OH
MM1114.00 Dexchlorpheniramine Maleate 2438-32-6 100mg N
OH
N
O

MM0059.00- Impurity A (EP) as Maleate: (3RS)-N,N-Dimethyl-3- N


N
O

OH
phenyl-3-(pyridin-2-yl)propan-1-amine Maleate 132-20-7 250mg OH

0250 (Pheniramine Maleate) O

Cl

HCl
MM1114.03 Dexchlorpheniramine N-Oxide Dihydrochloride n/a 100mg N +
2
N
O

Dexibuprofen
OH
MM3534.00 Dexibuprofen 51146-56-6 250mg
O

O
MM3534.01 Dexibuprofen Methyl Ester 81576-55-8 100mg O

O
MM3534.02 Dexibuprofen Ethyl Ester 272458-63-6 100mg O

O
MM3534.03 Dexibuprofen Isopropyl Ester 1114975-39-1 100mg O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-172
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O OH
Dexibuprofen 1,3-Butylene Glycol Esters (Mixture of Regio-
MM3534.04 n/a 100mg
and Stereoisomers) O OH

OH
O
MM3534.05 Dexibuprofen 2,3-Butylene Glycol Ester n/a 100mg O

OH
O

O
Dexibuprofen 1,2-Propylene Glycol Esters (Mixture of Regio-
MM3534.06 n/a 100mg
and Stereoisomers) O
OH
O

OH
O OH

O
Dexibuprofen 1,2,3-Propanetriol Esters (Mixture of Regio-
MM3534.07 n/a 100mg
and Stereoisomers) O
OH
O
OH

Dexketoprofen Trometamol
O
OH

MM3535.00 Dexketoprofen Trometamol 156604-79-4 250mg O


OH
HO
NH2
OH

O
OH
MM3535.08 Dexketoprofen 22161-81-5 250mg O

O
O
MM3535.01 Dexketoprofen Methyl Ester 81601-91-4 100mg O

O
O
MM3535.02 Dexketoprofen Ethyl Ester 136656-97-8 100mg O

O
O
MM3535.03 Dexketoprofen Isopropyl Ester 851775-73-0 100mg O

O
O

O OH
MM3535.04- Dexketoprofen 1,3-Butylene Glycol Esters (Mixture of Regio-
n/a 25mg O
0025 and Stereoisomers) O OH

O OH
MM3535.05- O
Dexketoprofen 2,3-Butylene Glycol Ester n/a 25mg O
0025
O OH
O

O
MM3535.06- Dexketoprofen 1,2-Propylene Glycol Esters (Mixture of
n/a 25mg O
0025 Regio- and Stereoisomers) O
OH
O

O OH
O OH

O
MM3535.07-
Dexketoprofen 1,2,3-Propanetriol Ester (Mixture of Isomers) n/a 25mg O

0025 O
OH
O
OH

MM3535.09- 3-[(2S)-2-(3-Benzoylphenyl)propanoyl]oxybutyl (2S)-2-(3- O


O
O O
n/a 25mg O

0025 Benzoylphenyl)propanoate
O
MM3535.10- [2-[(2S)-2-(3-Benzoylphenyl)propanoyl]oxy-1-methylpropyl] O O
O O
n/a 25mg O
0025 (2S)-2-(3-Benzoylphenyl)propanoate

MM3535.11- O O
2-[(2S)-2-(3-Benzoylphenyl)propanoyl]oxypropyl (2S)-2-(3- O
O
n/a 25mg O O

0025 Benzoylphenyl)propanoate

Dexmedetomidine Hydrochloride
N
MM3355.00 Dexmedetomidine Hydrochloride 145108-58-3 250mg HCl

N
H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-173
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Dexpanthenol
O
MM1352.00-
Dexpanthenol 81-13-0 250mg HO
N
H
OH

0250 OH

MM1352.01 3-Aminopropanol (Propanolamine) 156-87-6 100mg H 2N OH

O
HO
MM1352.03- (3R)-3-Hydroxy-4,4-dimethyldihydrofuran-2(3H)-one
599-04-2 25mg O
0025 (Pantolactone)

O
HO
MM1352.04 D,L-Pantolactone 79-50-5 100mg O

O
HO
MM1352.04-
D,L-Pantolactone 79-50-5 25mg O
0025

O
Calcium (D,L)-Pantoate (Calcium (RS)-2,4-Dihydroxy-3,3- HO
O Ca
2+

dimethylbutyrate)
MM1352.05 n/a 50mg
OH
2

O O
HO 2+
Ca
N O
MM1499.00 Calcium Pantothenate 137-08-6 250mg OH
H
2

Dexpropranolol Hydrochloride
OH
H
O N
MM3350.01 Dexpropranolol 5051-22-9 100mg

Dextroamphetamine Sulfate, see Dexamfetamine Sulfate

Dextromethorphan Hydrobromide
N
HBr
MM0033.00- Dextromethorphan Hydrobromide H

Monohydrate
6700-34-1 250mg H2O
0250
O

H
N

Impurity A (EP) as Hydrochloride: H HCl


MM0033.10 1087-69-0 100mg
ent-3-Methoxymorphinan Hydrochloride
O

H
N

MM0033.10- Impurity A (EP) as Hydrochloride: H HCl


1087-69-0 25mg
0025 ent-3-Methoxymorphinan Hydrochloride
O

Impurity B (EP) as (L)-Tartrate: ent-17- H HO


OH O

OH
MM0033.09 143-98-6 100mg
Methylmorphinan-3-ol (L)-Tartrate HO
O OH

N
MM0033.09- Impurity B (EP) as (L)-Tartrate: ent-17- H HO
OH O

OH
143-98-6 25mg
0025 Methylmorphinan-3-ol (L)-Tartrate HO
O OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-174
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity C (EP): ent-3-Methoxy-17- O N

methylmorphinan-10-one H
MM0033.02
Related compound C (USP): 3-Methoxy-17-methyl-9
57969-05-8 100mg
Alpha,13 Alpha,14 Alpha-morphinan-10-one O

Impurity C (EP): ent-3-Methoxy-17- O N

MM0033.02- methylmorphinan-10-one H
Related compound C (USP): 3-Methoxy-17-methyl-9
57969-05-8 25mg
0025
Alpha,13 Alpha,14 Alpha-morphinan-10-one O

O
+
N

MM0033.11 Dextromethorphan N-Oxide Hydrochloride 1177419-85-0 100mg H HCl

Dextropropoxyphene Hydrochloride (Propoxyphene Hydrochloride)


N

O
MM0098.01-
Dextropropoxyphene Hydrochloride 1639-60-7 CS 250mg O
HCl

0250

MM0098.00 Dextropropoxyphene 469-62-5 CS 50mg O

Impurity A (EP): (2S,3R)-4-(Dimethylamino)-


1,2-diphenyl-3-methylbutan-2-ol (Oxyphene)
MM0098.06 OH
Related compound A (USP): alpha-d-4-dimethylamino-1,2-
38345-66-3 100mg
diphenyl-3-methyl-2-butanol hydrochloride

Impurity A (EP): (2S,3R)-4-(Dimethylamino)-


MM0098.06- 1,2-diphenyl-3-methylbutan-2-ol (Oxyphene)
OH
Related compound A (USP): alpha-d-4-dimethylamino-1,2-
38345-66-3 25mg
0025
diphenyl-3-methyl-2-butanol hydrochloride

Impurity B (EP) as Hydrochloride: (1S,2R)-1-


N
Benzyl-3-(dimethylamino)-2-methyl-1-
O
MM0098.07- phenylpropyl Acetate Hydrochloride O
HCl

(Acetoxyphene Hydrochloride)
n/a 25mg
0025
Related compound B (USP): alpha-d-2-Acetoxy-4-
dimethylamino-1,2-diphenyl-3-methylbutane
N

Impurity B (EP): (1S,2R)-1-Benzyl-3-(dimethylamino)-2- O


methyl-1-phenylpropyl Acetate (Acetoxyphene)
MM0098.12 O
Related compound B (USP): alpha-d-2-Acetoxy-4-
33318-28-4 100mg
dimethylamino-1,2-diphenyl-3-methylbutane

Impurity B (EP): (1S,2R)-1-Benzyl-3-(dimethylamino)-2- O


MM0098.12- methyl-1-phenylpropyl Acetate (Acetoxyphene)
O
Related compound B (USP): alpha-d-2-Acetoxy-4-
33318-28-4 25mg
0025
dimethylamino-1,2-diphenyl-3-methylbutane

MM0098.08- Impurity C (EP) as Hydrochloride: (1S,2R)-1-- O


HCl
(dimethylamino)-2-methyl-1-phenyl-Butanoate Hydrochloride n/a 25mg O

0025 (Butyroxy-Hydrochloride)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-175
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0291.04 Toluene 108-88-3 100mg

Impurity F (EP) as Hydrochloride: (2RS)-3-(Dimethyl-


MM0098.11 amino)-2-methyl-1-phenylpropan-1-one Hydro- 5400-92-0 50mg N HCl

O
chloride

Dextrothyroxine Sodium
I
I O
NH2
MM1813.01 Dextrothyroxine 51-49-0 100mg HO I
OH

I O

Diacerein
O O

OH

MM1318.00 Diacerein 13739-02-1 250mg


O O O

O O

OH
HO
OH
Impurity A (Pharmeuropa): (10S)-1,8-Dihydroxy-3- O
HO
MM1318.01 (hydroxymethyl)-10- -D-glucopyranosyl-10H-anthracen-9-one 1415-73-2 100mg H H
OH
(Aloin, Barbaloin)
OH O OH

OH
HO
OH
Impurity A (Pharmeuropa): (10S)-1,8-Dihydroxy-3- O
MM1318.01- HO
(hydroxymethyl)-10- -D-glucopyranosyl-10H-anthracen-9-one 1415-73-2 25mg H H
OH
0025 (Aloin, Barbaloin)
OH O OH

Impurity B (EP): 1,8-Dihydroxy-3-(hydroxymethyl)- OH


MM1318.02 481-72-1 100mg
anthracene-9,10-dione (Aloe-Emodin)
OH O OH

MM1318.02- Impurity B (EP): 1,8-Dihydroxy-3-(hydroxymethyl)- OH


481-72-1 25mg
0025 anthracene-9,10-dione (Aloe-Emodin)
OH O OH

Diamfenetide
O O
O O O

MM3040.00 Diamfenetide 36141-82-9 50mg N


H
N
H

Diaveridine
O N NH2

MM3039.00 Diaveridine 5355-16-8 250mg O


N

NH2

Diazepam
O
N

MM0023.00-
Diazepam 439-14-5 CS 250mg Cl N
0250

H O
N

Impurity A (EP): 7-Chloro-5-phenyl-1,3-


MM0023.02- Cl N
dihydro-2H-1,4-benzodiazepin-2-one 1088-11-5 CS 25mg
0025 (Nordazepam)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-176
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
Cl
N

Impurity B (EP): 2-Chloro-N-(4-chloro-2- O


MM0023.04 6021-21-2 100mg Cl
benzoylphenyl)-N-methylacetamide

O
Cl
N

MM0023.04- Impurity B (EP): 2-Chloro-N-(4-chloro-2- O


6021-21-2 25mg Cl
0025 benzoylphenyl)-N-methylacetamide

Impurity C (EP): 3-Amino-6-chloro-1- N O

MM0023.03- methyl-4-phenylquinolin-2(1H)-one Cl N H2
Related compound B (USP): 3-Amino-6-chloro-1-methyl-4-
5220-02-0 25mg
0025
phenylcarbostyril

Impurity D (EP): [5-Chloro-2-(methylamino)- NH

MM0023.01- phenyl]phenylmethanone (5-Chloro-2- O


(methylamino)benzophenone) 1022-13-5 25mg Cl
0025 Related compound A (USP): 2-methylamino-5-
chlorobenzophenone

O
Cl
NH

O
MM0023.05 2'-Benzoyl-2,4'-dichloroacetanilide 4016-85-7 100mg Cl

O
Cl
NH

MM0023.05- O
2'-Benzoyl-2,4'-dichloroacetanilide 4016-85-7 25mg Cl
0025

Diazoxide
O O
Cl S
MM3038.00 Diazoxide 364-98-7 100mg NH

Dibenamine Hydrochloride
O
N
MM3037.02-
N,N-Dibenzyl-2-methoxyethanamine 57619-22-4 25mg
0025
O
N Cl
MM3037.05- N-Benzyl-N-(2-chloroethoxy)-1-phenylmethanamine HCl
n/a 25mg
0025 Hydrochloride

Dibucaine Hydrochloride, see Cinchocaine Hydrochloride

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-177
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Dibutyl Phthalate
O

O
MM3386.00 Dibutyl Phthalate 84-74-2 250mg O

Dibutyl Sebacate
O O

MM0925.00 Dibutyl Sebacate 109-43-3 500mg


O O

2,4-Dichlorobenzyl Alcohol
OH
MM0739.00 2,4-Dichlorobenzyl Alcohol 1777-82-8 250mg
Cl Cl

Cl
OH
MM0739.02 Impurity A (EP): (2,5-Dichlorophenyl)methanol 34145-05-6 100mg
Cl

Cl
MM0739.02- OH
Impurity A (EP): (2,5-Dichlorophenyl)methanol 34145-05-6 25mg
0025 Cl

OH

MM0739.04 Impurity C (EP): (3,4-Dichlorophenyl)methanol 1805-32-9 100mg Cl


Cl

OH
MM0739.04-
Impurity C (EP): (3,4-Dichlorophenyl)methanol 1805-32-9 25mg Cl
0025
Cl

O OH

Cl
MM0014.05 Impurity E (EP): 2,4-Dichlorobenzoic Acid 50-84-0 100mg

Cl

Impurity G (EP): 1,1'-(Oxydimethylene)bis(2,4- O


MM0739.01 207974-13-8 100mg Cl Cl Cl Cl
dichlorobenzene) (Bis-(2,4-dichlorobenzyl) Ether)

MM0739.01- Impurity G (EP): 1,1'-(Oxydimethylene)bis(2,4- O


207974-13-8 25mg Cl Cl Cl Cl
0025 dichlorobenzene) (Bis-(2,4-dichlorobenzyl) Ether)

Dichloroxylenol
OH

MM2546.00 Dichloroxylenol 133-53-9 100mg Cl Cl

Dichlorphenamide
O O O O
S S
H2 N NH2
MM1795.00 Dichlorphenamide 120-97-8 100mg Cl
Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-178
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Diclofenac Sodium
+
O Na

O
NH
MM0006.00 Diclofenac Sodium 15307-79-6 500mg Cl Cl

Impurity A (EP): 1-(2,6-Dichlorophenyl)-1,3- O


N
dihydro-2H-indol-2-one
Related compound A (USP): N-(2,6-dichlorophenyl)indolin- Cl Cl
MM0006.01 15362-40-0 100mg
2-one

Impurity A (EP): 1-(2,6-Dichlorophenyl)-1,3- O


N
MM0006.01- dihydro-2H-indol-2-one
Related compound A (USP): N-(2,6-dichlorophenyl)indolin-
15362-40-0 25mg Cl Cl
0025
2-one

Impurity B (EP): 2-[(2,6-Dichlorophenyl)amino]- NH


MM0006.03 22121-58-0 100mg
benzaldehyde Cl Cl

MM0006.03- Impurity B (EP): 2-[(2,6-Dichlorophenyl)amino]- NH


22121-58-0 25mg
0025 benzaldehyde Cl Cl

OH

Impurity C (EP): [2-[(2,6-Dichlorophenyl)- NH


MM0006.04 27204-57-5 100mg
amino]phenyl]methanol Cl Cl

OH

MM0006.04- Impurity C (EP): [2-[(2,6-Dichlorophenyl)- NH


27204-57-5 25mg
0025 amino]phenyl]methanol Cl Cl

OH

O
Impurity D (EP): 2-[2-[(2-Bromo-6-chloro- NH
MM0006.09 127792-23-8 100mg
phenyl)amino]phenyl]acetic Acid Br Cl

OH

O
MM0006.09- Impurity D (EP): 2-[2-[(2-Bromo-6-chloro- NH
127792-23-8 25mg
0025 phenyl)amino]phenyl]acetic Acid Br Cl

+
O Na

O
Impurity D (EP) as Sodium Salt: Sodium 2-[2-[(2- NH
MM0006.05 127792-45-4 100mg
Bromo-6-chlorophenyl)amino]phenyl]acetate Br Cl

+
O Na

O
MM0006.05- Impurity D (EP) as Sodium Salt: Sodium 2-[2-[(2- NH
127792-45-4 25mg
0025 Bromo-6-chlorophenyl)amino]phenyl]acetate Br Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-179
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
MM0006.02 Impurity E (EP): 1,3-Dihydro-2H-indol-2-one 59-48-3 100mg
N
H

MM0006.02- O
Impurity E (EP): 1,3-Dihydro-2H-indol-2-one 59-48-3 25mg
0025 N
H

Cl

HN
Impurity F (EP): N-(4-Chlorophenyl)-2-(2,6-dichlorophenyl)
MM0006.36 560075-65-2 100mg O
acetamide
Cl Cl

Cl

HN
MM0006.36- Impurity F (EP): N-(4-Chlorophenyl)-2-(2,6-dichlorophenyl)
560075-65-2 25mg O
0025 acetamide
Cl Cl

O
MM0006.06- N
1-(2-Bromo-6-chlorophenyl)indolin-2-one 1219112-85-2 25mg Br Cl
0025

Methyl 2-[2-[(2,6-Dichlorophenyl)amino]- NH
O

MM0006.10 phenyl]acetate 15307-78-5 100mg Cl Cl


(Methyl Ester of Diclofenac)

MM0006.10- Methyl 2-[2-[(2,6-Dichlorophenyl)amino]- NH


O

phenyl]acetate 15307-78-5 25mg Cl Cl


0025 (Methyl Ester of Diclofenac)

Ethyl 2-[2-[(2,6-Dichlorophenyl)amino]- NH
O

MM0006.11 phenyl]acetate 15307-77-4 100mg Cl Cl


(Ethyl Ester of Diclofenac)

MM0006.11- Ethyl 2-[2-[(2,6-Dichlorophenyl)amino]- NH


O

phenyl]acetate 15307-77-4 25mg Cl Cl


0025 (Ethyl Ester of Diclofenac)

Isopropyl 2-[2-[(2,6-Dichlorophenyl)amino]- O
NH
MM0181.06 phenyl]acetate 66370-79-4 100mg Cl Cl
(Isopropyl Ester of Diclofenac)

Isopropyl 2-[2-[(2,6-Dichlorophenyl)amino]- O
MM0181.06- NH
phenyl]acetate 66370-79-4 25mg Cl Cl
0025 (Isopropyl Ester of Diclofenac)

OH

MM0006.12 2-(2,6-Dichlorophenylamino)benzoic Acid 13625-57-5 100mg NH


Cl Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-180
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
MM0006.12-
2-(2,6-Dichlorophenylamino)benzoic Acid 13625-57-5 25mg NH
0025 Cl Cl

Cl
H
N
MM0006.15 2,6-Dichlorodiphenylamine 15307-93-4 100mg
Cl

Cl
H
MM0006.15- N
2,6-Dichlorodiphenylamine 15307-93-4 25mg
0025
Cl

MM0006.16- NH
2-Bromo-6-chlorodiphenylamine 123790-84-1 25mg Br Cl
0025

O
N
MM0006.17 1-(2,6-Dichlorophenyl)indolin-2,3-dione 24542-74-3 100mg
Cl Cl

+
O K

O
NH
MM0006.18 Diclofenac Potassium 15307-81-0 100mg Cl Cl

Cl

2-Chloro-N-(2,6-dichlorophenyl)-N- N O
MM0006.19
phenylacetamide
15308-01-7 100mg Cl Cl

Cl

MM0006.19- 2-Chloro-N-(2,6-dichlorophenyl)-N- N O
phenylacetamide
15308-01-7 25mg Cl Cl
0025

OH

O
MM0006.20- 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]- NH

acetic Acid (Diclofenac)


15307-86-5 250mg Cl Cl
0250

N H2
Cl Cl
MM0006.21 2,6-Dichloroaniline 608-31-1 100mg

N H2
MM0006.21- Cl Cl
2,6-Dichloroaniline 608-31-1 25mg
0025

NH2
Br Cl
MM0006.22 2-Bromo-6-chloroaniline 59772-49-5 100mg

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-181
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

NH2
MM0006.22- Br Cl
2-Bromo-6-chloroaniline 59772-49-5 25mg
0025

OH

O
NH
MM0006.23- Cl Cl
4'-Hydroxydiclofenac 64118-84-9 25mg
0025

OH

OH

O
NH H
MM0006.25 Diethylammonium Diclofenac 78213-16-8 250mg Cl Cl
N

N
MM0006.27 N-Acetyl-N-phenyl-2,6-dichloroaniline 84803-53-2 100mg Cl Cl

MM0006.27- N
N-Acetyl-N-phenyl-2,6-dichloroaniline 84803-53-2 25mg Cl Cl
0025

O
MM0006.28 Diethyl Phthalate 84-66-2 100mg O

H
N
MM0006.31 2'-Chloroacetanilide 533-17-5 100mg
O
Cl

H
N
MM0006.31-
2'-Chloroacetanilide 533-17-5 25mg
0025 O
Cl

Br
MM0006.32 Bromobenzene 108-86-1 100mg

O O OH

O OH O
NH NH
Cl Cl Cl Cl
MM0006.37 Diclofenac Butylene Glycol Ester (Mixture of Isomers) n/a 50mg
OH
O

O
NH
MM0006.38 Diclofenac 2,3-Butylene Glycol Ester 95093-57-5 100mg
Cl Cl

OH
O O
OH
O O
NH NH
MM0006.39 Diclofenac 1,2-Propylene Glycol Ester (Mixture of Isomers) n/a 100mg Cl Cl Cl Cl

MM0217.14 2-Chlorobenzoic Acid 118-91-2 100mg OH

Cl

MM0217.14- OH
2-Chlorobenzoic Acid 118-91-2 25mg
0025
Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-182
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
MM3572.04- Cl Cl
2,6-Dichlorophenol 87-65-0 100mg
0100

Dicloxacillin Sodium
O
Impurity C (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
MM0026.04 551-16-6 100mg
heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H

O
Impurity C (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
MM0026.04- dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
551-16-6 25mg
0025 heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H

Dicumarol
O OO O

MM3051.00 Dicumarol 66-76-2 250mg


OH OH

Dicyclomine Hydrochloride, see Dicycloverine Hydrochloride

Dicycloverine Hydrochloride (Dicyclomine Hydrochloride)


O
N

MM0766.00 Dicycloverine Hydrochloride 67-92-5 250mg O HCl

Didanosine
O
N
HN
MM1047.00 Didanosine 69655-05-6 250mg HO
N N
O

Impurity A (EP): 1,7-Dihydro-6H-purin-6-one (Hypoxanthine) N


HN
Related compound A (USP): Hypoxanthine
MM1047.01 68-94-0 100mg
N N
H

Impurity A (EP): 1,7-Dihydro-6H-purin-6-one (Hypoxanthine) N


MM1047.01- HN
Related compound A (USP): Hypoxanthine
68-94-0 25mg
0025
N N
H

N H2
N
Impurity G (EP): 9-(2,3-Dideoxy- -D-glycero- N
MM1047.02 pentofuranosyl)-9H-purin-6-amine (2 ,3 -Dideoxyadenosine) 4097-22-7 100mg HO
N N
Related compound B (USP): 2',3'-dideoxyadenosine O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-183
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N H2
N
Impurity G (EP): 9-(2,3-Dideoxy- -D-glycero- N
MM1047.02-
pentofuranosyl)-9H-purin-6-amine (2 ,3 -Dideoxyadenosine) 4097-22-7 25mg HO
N N
0025 Related compound B (USP): 2',3'-dideoxyadenosine O

Dienogest
N
OH

MM1274.00 Dienogest 65928-58-7 250mg H

H
O

H
MM1007.03 Impurity B (EP): Estra-4,9-diene-3,17-dione 5173-46-6 100mg
H
O

MM1007.03- H
Impurity B (EP): Estra-4,9-diene-3,17-dione 5173-46-6 25mg
0025 H
O

O
Impurity L (EP): Spiro[1,3-dioxolan-2,3 -estra-5 (10 ),9 (11 )-
MM1274.02- H
dien]-17 -one (Estra-5(10),9(11)-diene-3,17-dione 3-Ethylene 5571-36-8 25mg O H
0025
Ketal) O

Diethanolamine Fusidate
O

H OH
MM3832.00- HO HO OH
O
Diethanolamine Fusidate 16391-75-6 100mg H O
N
H
0100 HO
H

Diethazine Hydrochloride

N
N
MM1593.00 Diethazine Hydrochloride 341-70-8 50mg S
HCl

+
N HCl
MM1593.08- N
O
Diethazine N-Oxide Hydrochloride n/a 25mg S

0025

N
MM1593.03- N
Diethazine Sulfoxide 10078-16-7 25mg S
0025 O

N
MM1593.04- N
Diethazine Sulfone 13401-03-1 25mg O S
0025 O

+
N HCl
MM1593.09- Diethazine Sulfoxide N-Oxide Hydrochloride (Diethazine N,S- N
O
n/a 25mg S
O
0025 Dioxide Hydrochloride)

+
N HCl
MM1593.10- Diethazine Sulfone N-Oxide Hydrochloride (Diethazine N
O
n/a 25mg O S
0025 N,S,S-Trioxide Hydrochloride) O

Diethylammonium Salicylate
O
H
MM3461.00 Diethylammonium Salicylate 4419-92-5 250mg OH N

OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-184
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Diethylcarbamazine Citrate
O

O OH
O

MM1640.00 Diethylcarbamazine Citrate 1642-54-2 250mg N


N N
OH
OH

OH
O

Diethylstilbestrol
OH

MM1628.00 Diethylstilbestrol 56-53-1 250mg


HO

Difenidol Hydrochloride

MM3053.00 Difenidol Hydrochloride 3254-89-5 250mg OH


N HCl

O
MM3053.01- +
N
Difenidol N-Oxide 40220-79-9 25mg OH
0025

Diflorasone Diacetate
O

O
O O

HO O
MM3529.00 Diflorasone Diacetate 33564-31-7 250mg H

F H
O
F

OH
O

HO OH
H
MM3529.01 Diflorasone 2557-49-5 100mg
F H
O

OH
O

HO OH
MM3529.01- H
Diflorasone 2557-49-5 25mg
0025 F H
O

Difloxacin Hydrochloride Trihydrate


F

N HCl
MM3418.01 Difloxacin Hydrochloride 91296-86-5 250mg N N

OH
F
O O

O
+
N
MM3418.04 Difloxacin N-Oxide Sodium Salt n/a 100mg N N

+
O Na
F
O O

O
MM3418.04- +
N
Difloxacin N-Oxide Sodium Salt n/a 25mg N N

0025 +
O Na
F
O O

Diflucortolone Valerate
O
O
O
HO

MM0600.00 Diflucortolone Valerate 59198-70-8 100mg F


H

H
O
F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-185
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Diflunisal
F
O

MM3050.00 Diflunisal 22494-42-4 250mg OH


F
OH

F
O

MM3050.01 Diflunisal Methyl Ester 55544-00-8 100mg O


F
OH

F
O
MM3050.01-
Diflunisal Methyl Ester 55544-00-8 25mg O
0025 F
OH

F
O
MM3050.02-
Diflunisal Ethyl Ester 126093-86-5 25mg O

0025 F
OH

F
O
MM3050.03-
Diflunisal Isopropyl Ester 1381777-24-7 25mg O

0025 F
OH

Difluprednate
O

O
O O

HO O
MM3567.00 Difluprednate 23674-86-4 250mg H

F H
O
F

Digitoxin
O O

MM0336.01-
Digitoxigenin 143-62-4 25mg H

0025 H OH
HO
H

Digoxin
O O O O
O

MM0212.00 Digoxin 20830-75-5 250mg HO


OH
HO O
OH
H H

HO
H
OH

Dihydrocodeine Hydrogen Tartrate


N
OH O
MM0812.00-
Dihydrocodeine Hydrogen Tartrate H HO
OH
5965-13-9 CS 250mg O OH
0250 O O OH

HCl
MM0812.07 Dihydrocodeine Hydrochloride 36418-29-8 CS 100mg H

O O OH

MM0004.00 Impurity A (EP) as Monohydrate: Codeine Monohydrate 6059-47-8 CS 100mg H H2O

O O OH

Impurity A (EP) as Phosphate Hemihydrate: Codeine H


HO
P
OH

OH
H2O
MM0442.00 41444-62-6 CS 100mg O

Phosphate Hemihydrate O O OH
2
2

Impurity B (EP) as Hydrochloride Trihydrate: Morphine H HCl H 2O


MM0037.00 6055-06-7 CS 250mg 3

Hydrochloride Trihydrate HO O OH

Impurity B (EP) as Hemisulphate Pentahemihydrate: H HO S O H


O
H2O
5
MM0280.00 6211-15-0 CS 250mg O

Morphine Hemisulphate Pentahemihydrate HO O OH


2

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-186
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
+
N

MM0812.08 Dihydrocodeine N-Oxide 109667-32-5 100mg H

O O OH

Dihydroergocristine Mesilate
H
N O O O

MM1812.00 Dihydroergocristine Mesilate 24730-10-7 100mg HN

H
O
H
N

O
N
H
N
O
HO
S

OH

Dihydromorphine Hydrochloride
N

H
MM1369.01 Dihydromorphine 509-60-4 CS 100mg
HO O OH

Diisopropyl Adipate
O
HO
MM1008.02 Adipic Acid 124-04-9 250mg OH
O

Diloxanide Furoate
O
O O
MM3049.00 Diloxanide Furoate 3736-81-0 250mg Cl
N
O

Cl

Diltiazem Hydrochloride
O

S
MM0068.00-
Diltiazem Hydrochloride 33286-22-5 250mg N
O
O
HCl

0250 O

Impurity B (EP): (2S,3S)-2-(4-Methoxyphenyl)-


MM0068.02 4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin- 87447-47-0 100mg S
O
3-yl Acetate N O
H O

MM0068.02- Impurity B (EP): (2S,3S)-2-(4-Methoxyphenyl)-


4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin- 87447-47-0 25mg S
O
0025 3-yl Acetate N O
H O

O
Impurity D (EP) as Hydrochloride: (2S,3S)-2-(4-
Methoxyphenyl)-5-[2-(methylamino)ethyl]-4- S

MM0068.03 oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin- 130606-60-9 100mg N


O
O
HCl

O
3-yl Acetate Hydrochloride (N-Desmethyl-
diltiazem Hydrochloride) HN

O
Impurity D (EP) as Hydrochloride: (2S,3S)-2-(4-
MM0068.03- Methoxyphenyl)-5-[2-(methylamino)ethyl]-4- S

oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin- 130606-60-9 25mg N


O
O
HCl

O
0025 3-yl Acetate Hydrochloride (N-Desmethyl-
diltiazem Hydrochloride) HN

Impurity E (EP): (2S,3S)-3-Hydroxy-2-(4-


MM0068.04 methoxyphenyl)-2,3-dihydro-1,5- 42399-49-5 100mg S
OH
benzothiazepin-4(5H)-one N
H O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-187
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0068.04- Impurity E (EP): (2S,3S)-3-Hydroxy-2-(4-


methoxyphenyl)-2,3-dihydro-1,5- 42399-49-5 25mg S
OH
0025 benzothiazepin-4(5H)-one N
H O

Impurity F (EP): (2S,3S)-5-[2-(Dimethylamino)- S


OH
MM0068.05 ethyl]-3-hydroxy-2-(4-methoxyphenyl)-2,3- 42399-40-6 100mg N
dihydro-1,5-benzothiazepin-4(5H)-one O

MM0068.05- Impurity F (EP): (2S,3S)-5-[2-(Dimethylamino)- S


OH
ethyl]-3-hydroxy-2-(4-methoxyphenyl)-2,3- 42399-40-6 25mg N
0025 dihydro-1,5-benzothiazepin-4(5H)-one O

O
S

O
MM0068.07 Diltiazem Sulphoxide 370094-12-5 100mg N O
O

O
S
MM0068.07- O
Diltiazem Sulphoxide 370094-12-5 25mg N O
0025 O

NH2
(2S,3S)-3-(2-Aminophenyl)sulfanyl-2-hydroxy-3-(4- S
MM0068.13 42399-48-4 100mg
methoxyphenyl)propanoic Acid OH

HO
O

NH2
MM0068.13- (2S,3S)-3-(2-Aminophenyl)sulfanyl-2-hydroxy-3-(4- S
42399-48-4 25mg
0025 methoxyphenyl)propanoic Acid OH

HO
O

Dimenhydrinate
O
H

Dimenhydrinate
N
N
N Cl
MM0599.00 523-87-5 500mg O O N N

O
H
N N
MM0176.00 Impurity A (EP): Theophylline 58-55-9 500mg
O N N

8-[(2-(Diphenylmethoxy)ethyl)(methyl)- O
O
MM0599.04 amino]-1,3-dimethyl-3,7-dihydro-1H- 33120-34-2 100mg N
H
N
N

purine-2,6-dione O N N

MM0599.04- 8-[(2-(Diphenylmethoxy)ethyl)(methyl)- O
O
amino]-1,3-dimethyl-3,7-dihydro-1H- 33120-34-2 25mg N
H
N
N
0025 purine-2,6-dione O N N

N
MM0494.00- N
Impurity C (EP): Caffeine 58-08-2 250mg
0250
O N N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-188
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HCl
Impurity D (EP) as Dihydrochloride: N-[2-(Diphenylmethoxy) 2

MM0599.07 n/a 50mg N


ethyl]-N,N',N'-trimethylethane-1,2-diamine Dihydrochloride O N

Impurity E (EP): 8-Chloro-1,3,7-trimethyl-3,7- O

MM0599.08- dihydro-1H-purine-2,6-dione N
N
(8-Chlorocaffeine) 4921-49-7 25mg Cl
N
0025 Related compound E (USP): 8-chloro-3,7-dihydro-1,3,7- O N

trimethyl-1H-purine-2,6-dione
Impurity F (EP) as Hydrochloride: 2-(Diphenyl-
methoxy)-N-methylethanamine Hydrochloride H HCl
MM0490.03 53499-40-4 100mg N
(Diphenhydramine Impurity A Hydrochloride; O

Nordiphenhydramine Hydrochloride)
Impurity F (EP) as Hydrochloride: 2-(Diphenyl-
MM0490.03- methoxy)-N-methylethanamine Hydrochloride H HCl
53499-40-4 25mg N
0025 (Diphenhydramine Impurity A Hydrochloride; O

Nordiphenhydramine Hydrochloride)
Impurity G (EP) as Hydrochloride: N,N-Dimethyl-
2-[(RS)-(4-methylphenyl)(phenyl)methoxy]- HCl
MM0490.04 4024-34-4 100mg N
ethanamine Hydrochloride (4-Methyldiphen- O

hydramine Hydrochloride)
Impurity G (EP) as Hydrochloride: N,N-Dimethyl-
MM0490.04- 2-[(RS)-(4-methylphenyl)(phenyl)methoxy]- HCl
4024-34-4 25mg N

0025 ethanamine Hydrochloride (4-Methyldiphen- O

hydramine Hydrochloride)
Impurity H (EP) as Hydrochloride: 2-[(RS)-(4-
Bromophenyl)(phenyl)methoxy]-N,N-dimethyl-
HCl
MM0640.00 ethanamine Hydrochloride (4-Bromodiphen- 1808-12-4 100mg O
N

hydramine Hydrochloride; Bromazine Hydro- Br

chloride)
OH

MM0490.02 Impurity I (EP): Diphenylmethanol (Benzhydrol) 91-01-0 100mg

OH
MM0490.02-
Impurity I (EP): Diphenylmethanol (Benzhydrol) 91-01-0 25mg
0025

MM0630.01 Impurity J (EP): Diphenylmethanone (Benzophenone) 119-61-9 100mg

O
MM0630.01-
Impurity J (EP): Diphenylmethanone (Benzophenone) 119-61-9 25mg
0025

Impurity K (EP): [Oxybis(methanetriyl)]tetrabenzene O


MM0599.14 574-42-5 50mg
(Bis(diphenylmethyl) Ether)

MM0490.00-
Diphenhydramine Hydrochloride 147-24-0 250mg N
0250 O

HCl

O
H
N N
MM0155.02 8-Chlorotheophylline 85-18-7 100mg Cl
O N N

8-[N-(2-Diphenylmethoxyethyl)-N,N- N
N
N
+

MM0599.03 dimethylaminium]-1,3-dimethylxanthine 64487-94-1 100mg O N N


O

inner salt

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-189
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0599.03- 8-[N-(2-Diphenylmethoxyethyl)-N,N- N
N
N
+

dimethylaminium]-1,3-dimethylxanthine 64487-94-1 25mg O N N


O
0025 inner salt

Dimethadione
O O

MM3048.00 Dimethadione 695-53-4 100mg NH

Dimethisoquin Hydrochloride
N
O

MM1973.00 Dimethisoquin Hydrochloride 2773-92-4 100mg N


HCl

Dimethyl Fumarate
O
O
MM3170.00 Dimethyl Fumarate 624-49-7 250mg O
O

O
Monomethyl Fumarate HO
MM0352.03 O
Related compound A (USP)
2756-87-8 100mg
O

O
MM0352.03- Monomethyl Fumarate HO
O
Related compound A (USP)
2756-87-8 25mg
0025 O

O O
MM3170.01- O
Dimethyl Maleate 624-48-6 100mg
0100 O

O
MM0460.10- HO
Fumaric Acid 110-17-8 250mg OH
0250 O

Dimethyl Terephthalate
O

O
MM2520.00 Dimethyl Terephthalate 120-61-6 250mg O

Dimetindene Maleate
O

MM0595.00- OH
Dimetindene Maleate 3614-69-5 250mg N
N
OH

0250 O

N
MM0595.01 Impurity A (EP): 2-Ethylpyridine 100-71-0 100mg

Impurity B (EP) as Hydrochloride: 2-(1H-Inden- HCl


MM0595.02 92039-35-5 50mg
2-yl)-N,N-dimethylethanamine Hydrochloride N

Impurity D (EP) as Hydrochloride: (2RS)-2-Benzyl- HCl


MM0595.04 n/a 50mg
4-(dimethylamino)butanoic Acid Hydrochloride HO
N
O

Impurity E (EP) as Hydrochloride: (2RS)-2-[2-(Dimethyl- HCl


MM0595.10 5143-99-7 50mg N
amino)ethyl]indan-1-one Hydrochloride O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-190
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HCl
Impurity F (EP) as Hydrochloride: 2-(3-Butyl-1H-
MM0595.06 inden-2-yl)-N,N-dimethylethanamine Hydro- n/a 50mg N

chloride

MM0595.07- Impurity G (EP) as Hydrochloride: N,N-Dimethyl-


N
2-(3-phenyl-1H-inden-2-yl)ethanamine Hydro- n/a 25mg HCl

0025 chloride
Impurity I (EP) as Maleate: N-Methyl-2-[3-[(1RS)- O

OH
MM0595.11 1-(pyridin-2-yl)ethyl]-1H-inden-2-yl]ethanamine 135784-57-5 50mg N
N
H
OH

Maleate O

+
N HCl
O 2
MM0595.13 Dimetindene N-Oxide Dihydrochloride n/a 100mg N

Dimetridazole
O
+ N
MM3059.00 Dimetridazole N
551-92-8 250mg O
N

Diosmin
OH
HO O
O

MM0816.00 Diosmin 520-27-4 250mg HO


OH
O

HO
O O

OH
O

OH OH O

OH
O
Impurity A (EP): 1-(3-Hydroxy-4-methoxyphenyl)ethan-1-one
MM0816.01 6100-74-9 100mg
(Acetoisovanillone) O

OH
O
MM0816.01- Impurity A (EP): 1-(3-Hydroxy-4-methoxyphenyl)ethan-1-one
6100-74-9 25mg
0025 (Acetoisovanillone) O

Impurity B (EP): (2S)-7-[[6-O-(6-Deoxy- -L-


mannopyranosyl)- -D-glucopyranosyl]oxy]- HO
O
OH
O

5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-
O O O
HO O
MM0816.02 520-26-3 100mg OH
HO OH

2,3-dihydro-4H-1-benzopyran-4-one
OH OH O

(Hesperidin)
Impurity B (EP): (2S)-7-[[6-O-(6-Deoxy- -L-
MM0816.02- mannopyranosyl)- -D-glucopyranosyl]oxy]- HO
O
OH
O

5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-
O O O
HO O
520-26-3 25mg OH
HO OH
0025
2,3-dihydro-4H-1-benzopyran-4-one
OH OH O

(Hesperidin)
OH

Impurity F (EP): 5,7-Dihydroxy-2-(3-hydroxy-4- O

MM0816.06 methoxyphenyl)-4H-1-benzopyran-4-one 520-34-3 100mg HO O

(Diosmetin) OH O

OH

MM0816.06- Impurity F (EP): 5,7-Dihydroxy-2-(3-hydroxy-4- O

methoxyphenyl)-4H-1-benzopyran-4-one 520-34-3 25mg HO O

0025 (Diosmetin) OH O

OH

Impurity G (EP): (2S)-5,7-Dihydroxy-2-(3-hydroxy-4- O

MM0816.07 methoxyphenyl)-2,3-dihydro-4H-1-benzopyran-4-one 520-33-2 100mg HO O

(Hesperetin) OH O

OH

MM0816.07- Impurity G (EP): (2S)-5,7-Dihydroxy-2-(3-hydroxy-4- O

methoxyphenyl)-2,3-dihydro-4H-1-benzopyran-4-one 520-33-2 25mg HO O

0025 (Hesperetin) OH O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-191
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Diperodon Hydrochloride
O

N O N
H
O O
MM3054.01 Diperodon 101-08-6 100mg HN

Diphemanil Metilsulfate
+
N

O O

MM1163.00 Diphemanil Metilsulfate 62-97-5 100mg O


S
O

MM1163.01-
4-Diphenylmethylene-1-methylpiperidine 6071-93-8 25mg
0025

MM1163.02- 1-Methyl-a,a-diphenyl-4-piperidinemethanol ((1-Methyl-4-


6071-92-7 25mg OH
0025 piperidyl)diphenylmethanol)

Diphenhydramine Hydrochloride

MM0490.00-
Diphenhydramine Hydrochloride 147-24-0 250mg N
0250 O

HCl

Impurity A (EP) as Hydrochloride: 2-(Diphenyl-


methoxy)-N-methylethanamine Hydrochloride
MM0490.03 (Nordiphenhydramine Hydrochloride) 53499-40-4 100mg O
H
N
HCl

Related compound A (USP): 2-(Diphenylmethoxy)-N-


methylethanamine
Impurity A (EP) as Hydrochloride: 2-(Diphenyl-
MM0490.03- methoxy)-N-methylethanamine Hydrochloride
(Nordiphenhydramine Hydrochloride) 53499-40-4 25mg O
H
N
HCl

0025 Related compound A (USP): 2-(Diphenylmethoxy)-N-


methylethanamine
Impurity B (EP) as Hydrochloride: 2-[(RS)-
(4-Methylphenyl)phenylmethoxy]-N,N- HCl
MM0490.04 4024-34-4 100mg N
dimethylethanamine Hydrochloride O

(4-Methyldiphenhydramine Hydrochloride)
Impurity B (EP) as Hydrochloride: 2-[(RS)-
MM0490.04- (4-Methylphenyl)phenylmethoxy]-N,N- HCl
4024-34-4 25mg N

0025 dimethylethanamine Hydrochloride O

(4-Methyldiphenhydramine Hydrochloride)
Impurity C (EP) as Hydrochloride: 2-[(RS)-
(4-Bromophenyl)phenylmethoxy]-N,N- N
HCl
MM0640.00 1808-12-4 100mg
dimethylethanamine Hydrochloride Br
O

(Bromazine Hydrochloride)
OH

MM0490.02 Impurity D (EP): Diphenylmethanol (Benzhydrol) 91-01-0 100mg

OH
MM0490.02-
Impurity D (EP): Diphenylmethanol (Benzhydrol) 91-01-0 25mg
0025

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-192
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
Impurity E (EP): Diphenylmethanone
MM0630.01 119-61-9 100mg
(Benzophenone)

O
MM0630.01- Impurity E (EP): Diphenylmethanone
119-61-9 25mg
0025 (Benzophenone)

MM0490.01 Diphenhydramine N-Oxide 3922-74-5 100mg N


+O

MM0490.10- +O
Diphenhydramine N-Oxide Hydrochloride 13168-00-8 25mg N HCl
O
0025

3-(Benzhydryloxy)propane-1,2-diol
MM0490.09 Related compound B (USP): 3-(benzhydryloxy)propane-1,2- 19574-66-4 100mg
O OH
diol OH

3-(Benzhydryloxy)propane-1,2-diol
MM0490.09-
Related compound B (USP): 3-(benzhydryloxy)propane-1,2- 19574-66-4 25mg
0025 O OH
diol OH

Diphenoxylate Hydrochloride
HCl N

MM1056.00 Diphenoxylate Hydrochloride 3810-80-8 CS 250mg N

O O

Diphenylcyclopropenone
O

MM3487.00 Diphenylcyclopropenone 886-38-4 100mg

Diphenylpyraline Hydrochloride
O

MM0557.00 Diphenylpyraline Hydrochloride 132-18-3 500mg N


HCl

MM0155.01 Diphenylpyraline 147-20-6 100mg N

OH

MM0490.02 Diphenylmethanol (Benzhydrol) 91-01-0 100mg

OH
MM0490.02-
Diphenylmethanol (Benzhydrol) 91-01-0 25mg
0025

MM0630.01 Diphenylmethanone (Benzophenone) 119-61-9 100mg

O
MM0630.01-
Diphenylmethanone (Benzophenone) 119-61-9 25mg
0025

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-193
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0557.04 Diphenylpyraline N-Oxide 10020-59-4 100mg N


+

N-Desmethyldiphenylpyraline Hydrochloride NH HCl


MM0468.04
(4-(Diphenylmethoxy)piperidine Hydrochloride)
65214-86-0 100mg O

MM0468.04- N-Desmethyldiphenylpyraline Hydrochloride NH HCl

(4-(Diphenylmethoxy)piperidine Hydrochloride)
65214-86-0 25mg O
0025

Dipipanone Hydrochloride

MM0760.01 1,1-Diphenylbut-1-ene 1726-14-3 100mg

MM0760.02- 1-(1-Methyl-3,3-diphenylpropyl)- HCl

piperidine Hydrochloride
110246-09-8 25mg N
0025

Dipotassium Clorazepate Monohydrate (Clorazepate Dipotassium)


N H2

O
MM0028.03- Impurity A (EP): (2-Amino-5-chlorophenyl)phenyl- Cl
719-59-5 25mg
0025 methanone (Aminochlorobenzophenone)

H O
N

MM0023.02- Impurity B (EP): 7-Chloro-5-phenyl-1,3-dihydro- Cl N


1088-11-5 CS 25mg
0025 2H-1,4-benzodiazepin-2-one (Nordazepam)

Diprafenon Hydrochloride
O OH
2'-Hydroxy-3-phenylpropiophenone (1-(2-Hydroxyphenyl)-3-
MM0405.02 3516-95-8 100mg
phenylpropan-1-one)
O OH
MM0405.02- 2'-Hydroxy-3-phenylpropiophenone (1-(2-Hydroxyphenyl)-3-
3516-95-8 25mg
0025 phenylpropan-1-one)

Diprenorphine
N

MM1384.00 Diprenorphine 14357-78-9 50mg


OH
HO O O

Diprophylline (Dyphylline)
OH
O
OH
N
MM1191.00 Diprophylline 479-18-5 250mg N

O N N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-194
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N
Impurity A (EP): N-Methyl-5-(methylamino)-1H- N
MM0176.01 6736-40-9 100mg H
imidazole-4-carboxamide (Theophyllidine) N
HN
H

N
MM0176.01- Impurity A (EP): N-Methyl-5-(methylamino)-1H- N
6736-40-9 25mg H
0025 imidazole-4-carboxamide (Theophyllidine) N
HN
H

O
H
N
Impurity B (EP): 1,3-Dimethyl-3,7-dihydro-1H- N
MM0176.00 58-55-9 500mg
purine-2,6-dione (Theophylline) N
O N

N OH
MM0603.00- Impurity C (EP): 7-(2-Hydroxyethyl)-1,3-dimethyl- N
519-37-9 250mg
0250 3,7-dihydro-1H-purine-2,6-dione (Etofylline) O N N

OH
O
Impurity D (EP): 7-[(2RS)-2-Hydroxypropyl]-1,3-
N
MM1284.00 dimethyl-3,7-dihydro-1H-purine-2,6-dione 603-00-9 250mg N

(Proxyphylline) O N N

Dipyridamole
OH

N
N N
N OH
MM0462.00 Dipyridamole 58-32-2 100mg HO
N N
N

OH

OH
Impurity A (EP): 2,2'-[[4,6,8-Tri(piperidin-1-yl)- N

pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol N
N N
OH
N
Related compound A (USP): 2,2'-[4,6,8-Tri(piperidin-1-yl)
MM0462.01 16982-40-4 100mg N N
N

pyrimido[5,4-d]pyrimidin-2-yl]azanediyldiethanol
OH
Impurity A (EP): 2,2'-[[4,6,8-Tri(piperidin-1-yl)- N

MM0462.01- pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol N
N N
OH
N
Related compound A (USP): 2,2'-[4,6,8-Tri(piperidin-1-yl)
16982-40-4 25mg N N
0025 N

pyrimido[5,4-d]pyrimidin-2-yl]azanediyldiethanol
OH

Impurity C (EP): 2,2'-[[6-Chloro-4,8-di(piperidin-1- N

yl)pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol N
N N
OH
MM0462.03 N
Related compound C (USP): 2,2'-[6-chloro-4,8-di(piperidin-
54093-92-4 100mg Cl N
N
1-yl)pyrimido[5,4-d]pyrimidin-2-yl]azanediyldiethanol

OH

Impurity C (EP): 2,2'-[[6-Chloro-4,8-di(piperidin-1- N

MM0462.03- yl)pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol N
N N
OH
N
Related compound C (USP): 2,2'-[6-chloro-4,8-di(piperidin-
54093-92-4 25mg Cl N
0025 N
1-yl)pyrimido[5,4-d]pyrimidin-2-yl]azanediyldiethanol

Disodium Edetate
O
+
Na HO O
MM0886.00- O
N
N
O H2 O
Disodium Edetate Dihydrate 6381-92-6 250mg O OH Na
+ 2

0250 O

O
OH
MM0886.01-
Impurity A (EP): Nitrilotriacetic Acid 139-13-9 100mg HO N
0100 O
O HO

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-195
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Disopyramide

N
MM0108.00 Disopyramide 3737-09-5 500mg NH2

Impurity A (EP) as Dihydrogen Phosphate: (2RS)-


N
4-[Bis(1-methylethyl)amino]-2-phenyl-2-(pyridin- N
O
P OH
MM0108.02 n/a 100mg OH
2-yl)butanenitrile Dihydrogen Phosphate N
HO

(Diisopyronitrile Dihydrogen Phosphate)


Impurity A (EP) as Dihydrogen Phosphate: (2RS)-
N
MM0108.02- 4-[Bis(1-methylethyl)amino]-2-phenyl-2-(pyridin- N
O
P OH
n/a 25mg OH

0025 2-yl)butanenitrile Dihydrogen Phosphate N


HO

(Diisopyronitrile Dihydrogen Phosphate)


Impurity B (EP) as Dihydrogen Phosphate: (3RS)-,N-Bis(1- N
OH
MM0108.03- HO
methylethyl)-3-phenyl-3-(pyridin-2- n/a 25mg N O
P
OH

0025 yl)propan-1-amine Dihydrogen Phosphate

MM0108.04- Impurity C (EP) as Hydrogen Oxalate: (2RS)-4- N


NH
HO O

[(1-Methylethyl)amino]-2-phenyl-2-(pyridin- 88269-33-4 25mg NH2


HO O
0025 2-yl)butanamide Hydrogen Oxalate O

Impurity D (EP): (RS)-Phenyl(pyridin-2- N


MM0108.01 5005-36-7 100mg
yl)acetonitrile (Pyronitrile)

MM0108.01- Impurity D (EP): (RS)-Phenyl(pyridin-2- N


5005-36-7 25mg
0025 yl)acetonitrile (Pyronitrile)

O
+
N

MM0108.09- N
HCl
Disopyramide N-Oxide Dihydrochloride n/a 25mg NH2 2
0025 O

Distigmine Bromide
O
+
+ O N N
N N O

MM1167.00 Distigmine Bromide 15876-67-2 50mg O

Br
2

Disulfamide
O O O O
S S
MM3052.00 Disulfamide 671-88-5 50mg H2 N NH2

Cl

Disulfiram
N S
MM1946.00-
e Disulfiram 97-77-8 250mg N S
S N
0250 S
w

Impurity A (EP): Diethylthiocarbamic Thioanhydride N S N


MM1945.00 95-05-6 100mg
(Sulfiram) S S

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-196
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Dithranol (Anthralin)
OH O OH

MM0137.00 Dithranol 1143-38-0 500mg

O
MM0137.04- Impurity A (EP): Anthracen-9(10H)-one
90-44-8 25mg
0025 (Anthrone)

OH O OH

Impurity B (EP): 1,8-Dihydroxyanthracene-


MM0137.01 117-10-2 100mg
9,10-dione (Danthron)
O

OH O OH

Impurity C (EP): 4,4',5,5'-Tetrahydroxy-9,9'-


MM0137.02 bianthracenyl-10,10'(9H,9'H)-dione 31991-54-5 100mg
(Dithranol Dimer)

OH O OH

OH O OH

MM0137.02- Impurity C (EP): 4,4',5,5'-Tetrahydroxy-9,9'-


bianthracenyl-10,10'(9H,9'H)-dione 31991-54-5 25mg
0025 (Dithranol Dimer)

OH O OH

O OH
MM0137.05-
Impurity D (EP): 1-Hydroxyanthracen-9(10H)-one 1715-81-7 25mg
0025

Dobutamine Hydrochloride
OH
H

MM0675.00 Dobutamine Hydrochloride 49745-95-1 250mg HO

HO
N HCl

MM0384.00- Impurity A (EP) as Hydrochloride: Dopamine HO NH2


HCl
62-31-7 250mg
0250 Hydrochloride HO

OH

MM0675.02 Impurity B (EP): 4-(4-Hydroxyphenyl)butan-2-one 5471-51-2 100mg O

Impurity C (EP) as Hydrochloride: (2RS)-N-[2-(3,4-


Dimethoxyphenyl)ethyl]-4-(4-methoxyphenyl)butan-2-amine HCl
O
H

MM0675.03 Hydrochloride 51062-14-7 100mg O N

Related compound C (USP): N-(3,4-Dimethoxyphenethyl)-4- O

(4-methoxyphenyl)butan-2-amine
Impurity C (EP) as Hydrochloride: (2RS)-N-[2-(3,4-
MM0675.03- Dimethoxyphenyl)ethyl]-4-(4-methoxyphenyl)butan-2-amine HCl
O
H

Hydrochloride 51062-14-7 25mg O N

0025 Related compound C (USP): N-(3,4-Dimethoxyphenethyl)-4- O

(4-methoxyphenyl)butan-2-amine

Docetaxel
HO O OH

H H
HO O
O

MM3390.00 Docetaxel Anhydrous 114977-28-5 100mg NH


O OH
OO
O

O
O O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-197
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HO O OH
Impurity C (EP): 5 ,20-Epoxy-1,7 ,10 -trihydroxy-9-oxotax-
H H
HO O
MM3396.07- 11-ene-2 ,4,13 -triyl 4-Acetate 2-Benzoate 13-[(2R,3S)-3- O OH
O
O

153381-68-1 25mg O
NH OO
0025 [[(1,1-Dimethylethoxy)carbonyl]amino]-2-hydroxy-3- O O

phenylpropanoate] (7-epi-Docetaxel)
HO O
OH
Impurity E (EP): 5 ,20-Epoxy-4-(acetyloxy)-1,7 ,10 ,13 - HO
H H
MM1489.07 tetrahydroxy-9-oxotax-11-en-2 -yl Benzoate (10-Desacetyl- 32981-86-5 100mg OH O
O
O
baccatin III; 10-O-Deacetylbaccatin III) O
O

HO O
OH
Impurity E (EP): 5 ,20-Epoxy-4-(acetyloxy)-1,7 ,10 ,13 - HO
MM1489.07- H H
tetrahydroxy-9-oxotax-11-en-2 -yl Benzoate (10-Desacetyl- 32981-86-5 25mg OH O
0025 O
O
baccatin III; 10-O-Deacetylbaccatin III) O
O

O
Impurity F (EP): 5 ,20-Epoxy-1,7 -dihydroxy-9-oxotax-11- O O
OH
OH
ene-2 ,4,10 ,13 -tetrayl 4,10-Diacetate 2-Benzoate 13- O
H H
MM1489.00 33069-62-4 100mg O NH O
OH O
O
[(2R,3S)-3-(Benzoylamino)-2-hydroxy-3-phenylpropanoate] O
O
O
(Paclitaxel)

Docetaxel Trihydrate
HO O OH

H H
HO O

Docetaxel Trihydrate
O
O O H2O
OH
MM3396.00 148408-66-6 250mg NH 3
OO
O
O O

HO O OH
Impurity C (EP): 5 ,20-Epoxy-1,7 ,10 -trihydroxy-9-oxotax-
H H
HO O
MM3396.07- 11-ene-2 ,4,13 -triyl 4-Acetate 2-Benzoate 13-[(2R,3S)-3- O OH
O
O

153381-68-1 25mg O
NH OO
0025 [[(1,1-Dimethylethoxy)carbonyl]amino]-2-hydroxy-3- O O

phenylpropanoate] (7-epi-Docetaxel)
O

(4S,5R)-3-(tert-Butoxycarbonyl)-2,2-dimethyl-4- OH
MM3396.03 143527-70-2 100mg O
phenyloxazolidine-5-carboxylic Acid N O

MM3396.03- (4S,5R)-3-(tert-Butoxycarbonyl)-2,2-dimethyl-4- OH
143527-70-2 25mg O
0025 phenyloxazolidine-5-carboxylic Acid N O

NH2 O
MM3396.04- Ethyl (2R,3S)-3-Amino-2-hydroxy-3-phenylpropanoate O HCl
257947-33-4 25mg OH
0025 Hydrochloride
O

O O
OH
OH
O
H H
MM1489.00 Paclitaxel 33069-62-4 100mg O NH O
OH O
O

O
O
O

HO O
OH

HO
H H
MM1489.07 10-O-Deacetylbaccatin III 32981-86-5 100mg OH O
O
O
O
O

HO O
OH

HO
MM1489.07- H H
10-O-Deacetylbaccatin III 32981-86-5 25mg OH O
0025 O
O
O
O

Dodecylguanidinium Acetate

MM0451.05 Dimethyldodecylamine 112-18-5 100mg N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-198
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Dolutegravir Sodium
+
Na
O O
MM3758.00- N
O F F
Dolutegravir Sodium 1051375-19-9 250mg H
N N
O
0250 H
O

Domiphen Bromide
O

Domiphen Bromide
+
N Br

MM0726.00 538-71-6 250mg

Domperidone
O
MM0107.00- H

Domperidone 57808-66-9 250mg


HN

O
N
N
N
N

0250 Cl

O H
N
Impurity A (EP): 5-Chloro-1-(piperidin-4-yl)- N
MM0107.06 53786-28-0 100mg
1,3-dihydro-2H-benzimidazol-2-one HN
Cl

O H
N
MM0107.06- Impurity A (EP): 5-Chloro-1-(piperidin-4-yl)- N
53786-28-0 25mg
0025 1,3-dihydro-2H-benzimidazol-2-one HN
Cl

Impurity B (EP): 4-(5-Chloro-2-oxo-2,3- O H


N

MM0107.05 dihydro-1H-benzimidazol-1-yl)-1- n/a 100mg N

Cl
O N
formylpiperidine

MM0107.05- Impurity B (EP): 4-(5-Chloro-2-oxo-2,3- O H


N

dihydro-1H-benzimidazol-1-yl)-1- n/a 25mg N

Cl
O N
0025 formylpiperidine
Impurity F (EP): 1,3-Bis[3-[4-(5-
chloro-2-oxo-2,3-dihydro-1H- H
N
O O
H
N

benzimidazol-1-yl)piperidin-1-
N N
Cl
Cl N N N N
MM0107.03 n/a 50mg O

yl]propyl]-1,3-dihydro-2H-
benzimidazol-2-one
H
N
MM0107.07 1,3-Dihydro-2H-benzimidazol-2-one 615-16-7 100mg O
N
H

H
N
MM0107.07-
1,3-Dihydro-2H-benzimidazol-2-one 615-16-7 25mg O
0025 N
H

O H
N
MM0107.09- N

Domperidone N-Oxide 118435-03-3 25mg HN + Cl


N N
0025 O
O

Donepezil Hydrochloride
N
MM0677.00-
Donepezil Hydrochloride 120011-70-3 250mg O
O

HCl
0250 O

Impurity A (EP) as Hydrochloride: (2RS)-5,6-Dimethoxy-2- H


N
MM0677.02- [(piperidin-4-yl)methyl]-2,3-dihydro-1H-inden-1-one O
O
120013-39-0 25mg
0025 Hydrochloride (2,3-Dihydro-5,6-dimethoxy-2-[(4-piperidinyl) HCl
O

methyl]indan-1-one Hydrochloride)
O
Impurity B (EP): 5,6-Dimethoxy-2,3-dihydro-1H-inden-1-one O
MM0677.19 2107-69-9 100mg
(5,6-Dimethoxyindan-1-one)
O

O
MM0677.19- Impurity B (EP): 5,6-Dimethoxy-2,3-dihydro-1H-inden-1-one O
2107-69-9 25mg
0025 (5,6-Dimethoxyindan-1-one)
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-199
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N
Impurity D (EP): (2RS)-5,6-Dimethoxy-2-[(pyridin-4-yl) O
O
MM0677.08 methyl]-2,3-dihydro-1H-inden-1-one (5,6-Dimethoxy-2-[(4- 4803-57-0 100mg
O
pyridyl)methyl]indan-1-one)
N
Impurity D (EP): (2RS)-5,6-Dimethoxy-2-[(pyridin-4-yl) O
MM0677.08- O
methyl]-2,3-dihydro-1H-inden-1-one (5,6-Dimethoxy-2-[(4- 4803-57-0 25mg
0025 O
pyridyl)methyl]indan-1-one)
Impurity F (EP): (2E)-2-[(1-Benzylpiperidin-4-yl)methylidene]- O
O

MM0677.17- 5,6-dimethoxy-2,3-dihydro-1H-inden-1-one O
145546-80-1 25mg N
0025 Related compound A (USP): (E)-2-[(1-benzylpiperidin-4-yl)
methylene]-5,6-dimethoxyindan-1-one

2-[(1-Benzylpiperidin-4-yl)methylene]-2,3- O
N

MM0677.03 O
dihydro-5,6-dimethoxyinden-1-one
120014-07-5 100mg
O

MM0677.03- 2-[(1-Benzylpiperidin-4-yl)methylene]-2,3- O
N

120014-07-5 25mg O

0025 dihydro-5,6-dimethoxyinden-1-one
O

Br

MM0677.09- 1,1-Dibenzyl-4-[(5,6-dimethoxy-1oxo-2,3-dihydro- O
N
+

1H-inden-2-yl)methyl]piperidinium Bromide
844694-85-5 25mg O
0025
O

5,6-Dimethoxy-2-[(4-pyridyl)methylene]indan- O
O

MM0677.13
1-one
4803-74-1 100mg
O

MM0677.13- 5,6-Dimethoxy-2-[(4-pyridyl)methylene]indan- O
O

4803-74-1 25mg
0025 1-one O

O
+
N
MM0677.14-
Donepezil N-Oxide 120013-84-5 25mg O
O

0025 O

1-Benzyl-4-[(5,6-dimethoxy-2,3-dihydro-1H-inden- N

O
2-yl)methyl]piperidine
MM0677.15 844694-84-4 50mg
O

1-Benzyl-4-[(5,6-dimethoxy-1H-inden-2-yl)methyl]- N

MM0677.16 O
piperidine
120013-45-8 50mg
O

MM0677.18- 3-Oxodonepezil (2-[(1-Benzylpiperidin-4-yl)methyl]-5,6- O


O
N

dimethoxy-1H-indene-1,3(2H)-dione)
1023500-88-0 25mg
0025 O
O

N
MM0677.22- 2-[(1-Benzylpiperidin-4-yl)hydroxymethyl]-5,6- O
197010-20-1 25mg O

0025 dimethoxyindan-1-one (Hydroxydonepezil) O OH

N
MM0677.24- 2-[(1-Benzylpiperidin-4-yl)methyl]-3-hydroxy-5,6- O
O

2097683-67-3 25mg
0025 dimethoxyindan-1-one (3-Hydroxydonepezil) O
OH

Dopamine Hydrochloride
HO NH2
MM0384.00-
Dopamine Hydrochloride 62-31-7 250mg HO
HCl

0250
Impurity A (EP) as Hydrochloride: 5-(2-Amino-
ethyl)-2-methoxyphenol Hydrochloride HO NH2
HCl
MM0384.02
(4-O-Methyldopamine Hydrochloride)
645-33-0 100mg O

Related compound A (USP)


Impurity A (EP) as Hydrochloride: 5-(2-Amino-
MM0384.02- ethyl)-2-methoxyphenol Hydrochloride HO NH2
HCl

(4-O-Methyldopamine Hydrochloride)
645-33-0 25mg O
0025
Related compound A (USP)
Impurity C (EP): 2-(3,4-Dimethoxyphenyl)- O NH2

MM0384.04 ethanamine 120-20-7 100mg


O
Related compound C (USP)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-200
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HO NH2
HBr
MM0384.01 (R,S)- -Methyldopamine Hydrobromide 3459-15-2 100mg HO

HO NH2
MM0384.01- HBr
(R,S)- -Methyldopamine Hydrobromide 3459-15-2 25mg HO
0025

Doramectin
O
H
HO O O O
O
O O

MM3612.00 Doramectin 117704-25-3 100mg O O


OH
O
H
H

O
H
OH

O
H
HO O O O
O

MM3612.01- O O
H
O O O

5-Dehydroxyl-5-oxodoramectin 157483-78-8 25mg OH H

0025 O
H
O

Dorzolamide Hydrochloride
O O
O S S
MM0403.00- O

Dorzolamide Hydrochloride 130693-82-2 250mg H 2N


S
HCl

0250 HN

Impurity A (EP): (4R,6R)-4-(Ethylamino)-6-methyl-5,6-


dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-Dioxide O O
O S S
O
MM0403.01- ((4R,6R)-Dorzolamide) S
120279-95-0 25mg H 2N
0025 Related compound A (USP): (4R,6R)-4-(ethylamino)-5,6-
HN
dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide-
7,7-dioxide
O O
O S S
MM0403.18- 5,6-Dihydro-4-hydroxy-6-methyl-4H-thieno[2,3-b]thiopyran-2- O
S
120279-26-7 25mg H2 N
0025 sulfonamide 7,7-Dioxide
OH

Dosulepin Hydrochloride
N

MM0510.00-
Dosulepin Hydrochloride 897-15-4 250mg HCl

0250 S

N
Impurity A (EP): (E)-3-(5-Oxo-5 4-dibenzo[b,e]thiepin-11
MM0510.01 (6H)-ylidene)-N,N-dimethylpropan-1-amine (Dosulepin 42046-35-5 100mg
Sulfoxide) O
S

MM0510.01- Impurity A (EP): (E)-3-(5-Oxo-5 4-dibenzo[b,e]thiepin-11


(6H)-ylidene)-N,N-dimethylpropan-1-amine (Dosulepin 42046-35-5 25mg
0025 Sulfoxide) O
S

O
MM0510.02 Impurity B (EP): Dibenzo[b,e]thiepin-11(6H)-one 1531-77-7 100mg
S

O
MM0510.02-
Impurity B (EP): Dibenzo[b,e]thiepin-11(6H)-one 1531-77-7 25mg
0025
S

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-201
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity D (EP) as Hydrochloride: (E)-3-(5,5-Dioxo-5 6- N

MM0510.15- dibenzo[b,e]thiepin-11(6H)-ylidene)-N,N-dimethylpropan-1- HCl


25659-71-6 25mg
0025 amine Hydrochloride (Dosulepin Sulfone Hydrochloride) O S
O

N
H

MM0510.08 Nordosulepin Hydrochloride 24881-70-7 50mg HCl

+
N
O
MM0510.13- Dosulepin Sulfoxide N-Oxide Hydrochloride (Dosulepin N,S-
n/a 25mg HCl
0025 Dioxide Hydrochloride) S
O

+
N
O
MM0510.14- Dosulepin Sulfone N-Oxide Hydrochloride (Dosulepin N,S,S-
n/a 25mg HCl
0025 Trioxide Hydrochloride) S
O
O

Doxapram Hydrochloride
N O
HCl

MM0525.00 Doxapram Hydrochloride Monohydrate 7081-53-0 250mg N H2 O

N
O
O
+
MM0525.03 Doxapram N-Oxide n/a 100mg N
O

Doxazosin Mesilate
O

N O
MM0386.00-
Doxazosin Mesilate 77883-43-3 250mg
O N

N
N O

O O O
0250 NH2 S
OH

N O

MM0386.08 Doxazosin 74191-85-8 100mg O N

N
N O

O
NH2

O
Impurity A (EP): (2RS)-2,3-Dihydro-1,4-benzodioxine-
HO O
2-carboxylic Acid
MM0386.04 3663-80-7 100mg O
Related compound D (USP): 1,4-benzodioxane-2-carboxylic
acid

O
Impurity A (EP): (2RS)-2,3-Dihydro-1,4-benzodioxine-
HO O
MM0386.04- 2-carboxylic Acid
3663-80-7 25mg O
0025 Related compound D (USP): 1,4-benzodioxane-2-carboxylic
acid

Impurity B (EP) as Hydrochloride: 1-[(2RS)-2,3-


O
Dihydro-1,4-benzodioxin-2-ylcarbonyl]piperazine N O
HCl
MM0386.05 Hydrochloride 70918-74-0 100mg HN O

Related compound A (USP): N-(1,4-benzodioxane-2-


carbonyl)piperazine
Impurity B (EP) as Hydrochloride: 1-[(2RS)-2,3-
O

MM0386.05- Dihydro-1,4-benzodioxin-2-ylcarbonyl]piperazine N O
HCl
Hydrochloride 70918-74-0 25mg HN O

0025 Related compound A (USP): N-(1,4-benzodioxane-2-


carbonyl)piperazine
Impurity C (EP): 1,4-Bis(2,3-dihydro-1,4-benzodioxin- O

2-ylcarbonyl)piperazine O N O
MM0386.06 O N O
Related compound F (USP): N,N'-bis(1,4-benzodioxane-2-
617677-53-9 100mg
O

carbonyl)piperazine
Impurity C (EP): 1,4-Bis(2,3-dihydro-1,4-benzodioxin- O

MM0386.06- 2-ylcarbonyl)piperazine O N O
O N O
Related compound F (USP): N,N'-bis(1,4-benzodioxane-2-
617677-53-9 25mg
0025 O

carbonyl)piperazine

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-202
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity D (EP): 6,7-Dimethoxyquinazoline-2,4(1H,3H)- O


H
N O
dione
NH
Related compound B (USP): 6,7-dimethoxyquinazoline-2,4-
MM0085.07 28888-44-0 100mg O
O
dione
Impurity D (EP): 6,7-Dimethoxyquinazoline-2,4(1H,3H)- O
H
N O
MM0085.07- dione
NH
Related compound B (USP): 6,7-dimethoxyquinazoline-2,4-
28888-44-0 25mg O
0025
O
dione
Impurity E (EP): 2,4-Dichloro-6,7- O N Cl

dimethoxyquinazoline N
MM0085.06
Related compound E (USP): 2,4-dichloro-6,7-
27631-29-4 100mg O
Cl
dimethoxyquinazoline
Impurity E (EP): 2,4-Dichloro-6,7- O N Cl
MM0085.06- dimethoxyquinazoline N
Related compound E (USP): 2,4-dichloro-6,7-
27631-29-4 25mg O
0025 Cl
dimethoxyquinazoline
Impurity F (EP): 2-Chloro-6,7-dimethoxyquinazolin- O N Cl

4-amine N
O
Related compound C (USP): 2-chloro-4-amino-6,7-
MM0386.01 23680-84-4 100mg
NH2
dimethoxyquinazoline
Impurity F (EP): 2-Chloro-6,7-dimethoxyquinazolin- O N Cl
MM0386.01- 4-amine N
O
Related compound C (USP): 2-chloro-4-amino-6,7-
23680-84-4 25mg
0025 NH2
dimethoxyquinazoline
Impurity F (EP) as Mesilate: 2-Chloro-6,7-dimethoxy- O N Cl
quinazolin-4-amine Mesilate N
O
S
O
O
Related compound C (USP): 2-chloro-4-amino-6,7-
MM0386.12 n/a 100mg OH
NH2

dimethoxyquinazoline
Impurity F (EP) as Mesilate: 2-Chloro-6,7-dimethoxy- O N Cl
MM0386.12- quinazolin-4-amine Mesilate N
O
S
O
O
Related compound C (USP): 2-chloro-4-amino-6,7-
n/a 25mg OH
0025 NH2

dimethoxyquinazoline
NH

Impurity G (EP): 6,7-Dimethoxy-2-(piperazin-1- O N N

MM0085.01 60547-97-9 100mg


yl)quinazolin-4-amine O
N

NH2

NH

MM0085.01- Impurity G (EP): 6,7-Dimethoxy-2-(piperazin-1- O N N

60547-97-9 25mg
0025 yl)quinazolin-4-amine O
N

NH2

HCl H2O
Impurity G (EP) as Dihydrochloride Dihydrate: 6,7- 2 2 NH
MM0085.08- O N N
Dimethoxy-2-(piperazin-1-yl)quinazolin-4-amine n/a 25mg N
0025 O
Dihydrochloride Dihydrate NH2

NH2
O
N

Impurity H (EP): 2,2'-(Piperazine-1,4-diyl)bis(6,7- O N N


N N O

MM0085.03 102839-00-9 100mg


dimethoxyquinazolin-4-amine) O
N

NH2

NH2
O
N

MM0085.03- Impurity H (EP): 2,2'-(Piperazine-1,4-diyl)bis(6,7- O N N


N N O

102839-00-9 25mg
0025 dimethoxyquinazolin-4-amine) O
N

NH2

O O
MM0386.11-
Methyl (2RS)-1,4-Benzodioxane-2-carboxylate 3663-79-4 25mg O
0025

Doxepin Hydrochloride
N

MM0032.00-
Doxepin Hydrochloride 1229-29-4 250mg HCl

0250 O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-203
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP): Dibenzo[b,e]oxepin-11(6H)-one O


MM0032.03 (Doxepinone) 4504-87-4 100mg
Related compound A (USP): dibenzo[b,e]oxepin-11(6H)-one O

Impurity A (EP): Dibenzo[b,e]oxepin-11(6H)-one O


MM0032.03-
(Doxepinone) 4504-87-4 25mg
0025 Related compound A (USP): dibenzo[b,e]oxepin-11(6H)-one O

Impurity B (EP): (11RS)-11-[3-(Dimethylamino)- N


propyl]-6,11-dihydrodibenzo[b,e]oxepin- OH

MM0032.04 11-ol (Doxepinol) 4504-88-5 50mg


Related compound B (USP): (11RS)-11-[3-(dimethylamino) O

propyl]-6,11-dihydrodibenzo[b,e]oxepin-11-ol
Impurity C (EP) as Maleate: (E)-3-(Dibenzo[b,e]oxepin-
MM0032.10- (6H)-ylidene)-N-methylpropan-1-amine Maleate N
H
O

OH
(Desmethyldoxepin Maleate) n/a 25mg O
OH

0025 Related compound C (USP): (E-3-(dibenzo[b,e]oxepin-11(6H)- O

ylidene)-N-methylpropan-1-amine
Impurity C (EP) as Hydrochloride: (E)-3-(Dibenzo[b,e]oxepin-
N
11(6H)-ylidene)-N-methylpropan-1-amine Hydrochloride H
MM0032.13-
(Desmethyldoxepin Hydrochloride) 4504-96-5 25mg HCl
0025 O
Related compound C (USP): (E-3-(dibenzo[b,e]oxepin-11
(6H)-ylidene)-N-methylpropan-1-amine

NH

MM0032.08- Impurity C (EP) as E/Z-Mixture: (E,Z)-3-(Dibenzo[b,e]-


oxepin-11(6H)-ylidene)-N-methylpropan-1-amine 1225-56-5 25mg
0025 ((E,Z)-Desmethyldoxepin) O

Impurity D (EP) as Maleate: (Z)-3-(Dibenzo[b,e]oxepin- N OH


MM0032.09 147365-12-6 50mg OH
11(6H)-ylidene)-N,N-dimethylpropan-1-amine Maleate O
O

+
N
O
HCl
MM0032.12 Doxepin N-Oxide Hydrochloride n/a 100mg
O

+
N
O
MM0032.12- HCl
Doxepin N-Oxide Hydrochloride n/a 25mg
0025 O

Doxorubicin Hydrochloride
O OH O
OH
OH

MM0283.00 Doxorubicin Hydrochloride 25316-40-9 100mg O O OH


O
O HCl

NH2
OH

O OH
Impurity D (EP): (8S,10S)-6,8,10,11-Tetrahydroxy-8- O
OH
MM0283.01- OH
(hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydronaphthacene- 24385-10-2 25mg
0025 O O OH OH
5,12-dione (Doxorubicinone, Doxorubicin Aglycone)

Doxycycline Hyclate
OH O OH O O
OH HCl
2
N H2

MM0276.00 Doxycycline Hyclate 24390-14-5 100mg H H


OH
H 2O
OH

OH N
2

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-204
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Doxylamine Hydrogen Succinate


O

MM0101.00-
Doxylamine Hydrogen Succinate 562-10-7 250mg N
O
N
OH
OH

0250 O

Impurity A (EP) as Hydrogen Succinate: N,N- O

OH
MM0101.01 Dimethyl-2-[1(RS)-1-phenyl-1-(pyridin-4- n/a 50mg O
N OH

yl)ethoxy]ethanamine Hydrogen Succinate N O

Impurity B (EP) as Hydrochloride: (1RS)-1-Phenyl- HCl


MM0101.02 879671-67-7 50mg N
1-(pyridin-2-yl)ethanol Hydrochloride OH

Impurity C (EP) as Hydrogen Fumarate: N,N- O

OH

MM0101.03 Dimethyl-2-[(RS)-1-phenyl(pyridin-2-yl)- n/a 50mg N


O
N HO

methoxy]ethanamine Hydrogen Fumarate O

Impurity D (EP): Phenyl(pyridin-2-yl)methanone


MM0101.04 91-02-1 100mg
(2-Benzoylpyridine) N
O

MM0101.04- Impurity D (EP): Phenyl(pyridin-2-yl)methanone


91-02-1 25mg
0025 (2-Benzoylpyridine) N
O

MM0101.05 Doxylamine N-Oxide Dihydrochloride n/a 100mg N


O
N
+O HCl
2

MM0101.08-
N-Desmethyldoxylamine Hydrogen Succinate n/a 25mg N
O
H
N
OH
OH
0025 O

MM0101.09 Phenyl(2-pyridyl)methanol 14159-57-0 100mg


N
OH

MM0101.09-
Phenyl(2-pyridyl)methanol 14159-57-0 25mg
0025 N
OH

MM0101.11-
(1RS)-1-Phenyl-1-(pyridin-2-yl)ethanol N-Oxide 100393-43-9 25mg OH
0025
+
N O

Drofenine Hydrochloride

MM0768.00 Drofenine Hydrochloride 548-66-3 500mg O


N
HCl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-205
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Droperidol
F

MM0138.00 Droperidol 548-73-2 250mg O


N

N
O H

HN
MM0138.01- Impurity A (EP): 1-(1,2,3,6-Tetrahydropyridin- N
2147-83-3 25mg
0025 4-yl)-1,3-dihydro-2H-benzimidazol-2-one N
O H

MM0138.03- Impurity C (EP) as Chloride: 1-[4-(4-Fluorophenyl)-4- F

+
Cl

oxobutyl]-4-(2-oxo-2,3-dihydro-1H-benzimidazol-1-yl) 60373-76-4 25mg O


N
0025 pyridinium Chloride O
N
H

Impurity D (EP) as Hydrochloride: (1RS)-1-[4- F


O

(4-Fluorophenyl)-4-oxobutyl]-4-(2-oxo- O
N
+

MM0138.04 n/a 100mg


2,3-dihydro-1H-benzimidazol-1-yl)-1,2,3,6- HCl
O
N

N
H

tetrahydropyridine 1-Oxide Hydrochloride


Impurity D (EP) as Hydrochloride: (1RS)-1-[4- F
O
MM0138.04- (4-Fluorophenyl)-4-oxobutyl]-4-(2-oxo- O
N
+

n/a 25mg
0025 2,3-dihydro-1H-benzimidazol-1-yl)-1,2,3,6- HCl
O
N

N
H

tetrahydropyridine 1-Oxide Hydrochloride


O
Cl
MM0113.07 4-Chloro-4'-fluorobutyrophenone 3874-54-2 100mg
F

Dropropizine
N OH
MM1017.00-
Dropropizine 17692-31-8 250mg N OH

0250

Drospirenone
O

O
MM1203.00- H
Drospirenone 67392-87-4 250mg
0250 H H
O

Impurity E (EP): 3-Oxo-6 ,7 ,15 ,16 -tetrahydro-3 H,3 H-


dicyclopropa[6,7:15,16]pregn-4-ene-21,17-carbolactone (17- O

O
MM1203.05- Epidrospirenone) 90457-65-1 25mg
H

0025 Related compound A (USP): 17-Hydroxy- H H


O
6beta,7beta:15beta,16beta-dimethylene-3-oxo-17beta-pregn-4-
ene-21-carboxylic acid, gamma-lactone
O

Impurity G (EP): 7 -(Chloromethyl)-3-oxo-15 ,16 -dihydro-3 O


MM1203.07- H
H-cyclopropa[15,16]-17 -pregn-4-ene-21,17-carbolactone 932388-90-4 25mg H H
0025 O
(3 -Chloro-3 ,6-secodrospirenone) Cl

Impurity H (EP): 7 -(Chloromethyl)-3-oxo-15 ,16 -dihydro-3 O


MM1203.08- H
H-cyclopropa[15,16]pregn-4-ene-21,17-carbolactone (3 - 932388-89-1 25mg H H
0025 O
Chloro-3 ,6-seco-17-epidrospirenone) Cl

H
MM1203.12 3 ,5-Dihydroxy-15 ,16 -methylene-5 -androst-6-en-17-one 82543-15-5 100mg H H
HO
OH

MM1203.12- H
3 ,5-Dihydroxy-15 ,16 -methylene-5 -androst-6-en-17-one 82543-15-5 25mg H H
0025 HO
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-206
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Drostanolone Propionate
O

MM3574.00 Drostanolone Propionate 521-12-0 250mg H

H H

O
H

Droxidopa
OH O

MM3786.00- OH
Droxidopa 23651-95-8 250mg NH2
0250 HO
OH

Duloxetine Hydrochloride

HCl
MM1122.00- S
Duloxetine Hydrochloride 136434-34-9 250mg
0250 O N
H

Impurity A (EP) as Hydrochloride: (3R)-N-Methyl-3-


MM1122.11- (naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine
S HCl
Hydrochloride ((R)-Duloxetine Hydrochloride) 910138-96-4 25mg
0025 Related compound A (USP): (R)-N-Methyl-3-(naphthalen-1- O N
H

yloxy)-3-(thiophen-2-yl)propan-1-amine

S
Impurity B (EP): (1S)-3-(Methylamino)-1-(thiophen-2-yl)
MM1122.04 116539-55-0 100mg
propan-1-ol
HO N
H

S
MM1122.04- Impurity B (EP): (1S)-3-(Methylamino)-1-(thiophen-2-yl)
116539-55-0 25mg
0025 propan-1-ol
HO N
H

S
Impurity C (EP): 4-[(1RS)-3-(Methylamino)-1-(thiophen-2-yl)
MM1122.05 949095-98-1 100mg
propyl]naphthalen-1-ol N
H
HO

S
MM1122.05- Impurity C (EP): 4-[(1RS)-3-(Methylamino)-1-(thiophen-2-yl)
949095-98-1 25mg
0025 propyl]naphthalen-1-ol N
H
HO

OH

MM0043.04 Impurity D (EP): Naphthalen-1-ol (1-Naphthol) 90-15-3 100mg

OH
MM0043.04-
Impurity D (EP): Naphthalen-1-ol (1-Naphthol) 90-15-3 25mg
0025

MM1122.09 Impurity G (EP): 1-Fluoronaphthalene 321-38-0 100mg

S
MM1122.07- 1-[(1RS)-3-(Methylamino)-1-(thiophen-2-yl)propyl]naphthalen-
1346599-09-4 25mg N
0025 2-ol H
OH

(S)-4-[Methyl[3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl]
S
MM1122.13- amino]-4-oxobutanoic Acid ((S)-Duloxetine Succinamide)
199191-66-7 25mg O N

0025 Related compound H (USP): (S)-4-(Methyl[3-(naphthalen-1- OH


O
O
yloxy)-3-(thiophen-2-yl)propyl]amino)-4-oxobutanoic acid

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-207
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

S
MM1122.18-
(1S)-3-(Dimethylamino)-1-(thiophen-2-yl)propan-1-ol 132335-44-5 25mg
0025 HO N

O OH
MM1122.19- (3S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl) S

132335-47-8 25mg O N O OH
0025 propan-1-amine Oxalate (N-Methylduloxetine Oxalate)

MM1122.20- HCl
3-(Naphthalen-1-yloxy)propan-1-amine Hydrochloride 197504-23-7 25mg
0025 O NH2

S
MM1122.21- 3-(Dimethylamino)-1-(thiophen-2-yl)propan-1-one HCl
5424-47-5 25mg
0025 Hydrochloride O N

S
O
MM1122.22 3-Hydroxy-N-methyl-3-(thiophen-2-yl)propanamide 603996-87-8 100mg
HO N
H

S
MM1122.22- O
3-Hydroxy-N-methyl-3-(thiophen-2-yl)propanamide 603996-87-8 25mg
0025 HO N
H

Dutasteride
F F
O H
N F

MM1424.00 Dutasteride 164656-23-9 250mg H


F
H H
F F
O N
H H

O
OH

Impurity A (EP): 3-Oxo-4-aza-5 -androst-1-ene-17 - H


MM0415.05 104239-97-6 100mg
carboxylic Acid (Dutasteride Acid; Finasteride Acid) H H
O N
H H

O
OH

MM0415.05- Impurity A (EP): 3-Oxo-4-aza-5 -androst-1-ene-17 - H


104239-97-6 25mg
0025 carboxylic Acid (Dutasteride Acid; Finasteride Acid) H H
O N
H H

O
O

MM1424.04- Impurity C (EP): Ethyl 3-Oxo-4-aza-5 -androst-1-ene-17 - H


157307-36-3 25mg H
0025 carboxylate H
O N
H H

F
F
F
H 2N

MM1424.01 2,5-Bis-(trifluoromethyl)aniline 328-93-8 250mg

F
F
F

O
OH

MM1424.02 4-Androsten-3-one-17 -carboxylic Acid 302-97-6 100mg H

H H
O

O
OH

MM1424.02-
4-Androsten-3-one-17 -carboxylic Acid 302-97-6 25mg H

0025 H H
O

O
O

H
MM0415.02 Methyl 3-Oxo-4-aza-5 -androst-1-ene-17 -carboxylate 103335-41-7 100mg
H H
O N
H H

O
O

MM0415.02- H
Methyl 3-Oxo-4-aza-5 -androst-1-ene-17 -carboxylate 103335-41-7 25mg
0025 H H
O N
H H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-208
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
N
Cl
MM1424.11-
2,3-Dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) 84-58-2 100mg
0100 Cl
N
O

F F
O H
N F

MM1424.12- N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5 - H
164656-22-8 25mg H
F
0025 androstane-17 -carboxamide (Dihydrodutasteride) H
F F
O N
H H

O
OH

MM1424.14- O
H
17 -Carboxy-5-oxo-A-nor-3,5-secoandrostan-3-oic Acid 76763-14-9 25mg HO
0025 H H
O

O
OH

MM1424.15- H
3-Oxo-4-azaandrost-5-ene-17 -carboxylic Acid 103335-54-2 25mg H
0025 H
O N
H

O H
N

MM0415.07- N-Cyclohexyl-3-oxo-4-aza-5 -androst-1-ene-17 - H


133216-45-2 25mg H H
0025 carboxamide O N
H H

O H
N

MM0415.08- H
3-Oxo-N-phenyl-4-aza-5 -androst-1-ene-17 -carboxamide 158522-79-3 25mg H H
0025 O N
H H

Dyclonine Hydrochloride
O

MM3066.00 Dyclonine Hydrochloride 536-43-6 250mg O


N HCl

Dydrogesterone
O

Impurity B (EP): Pregna-4,6-diene-3,20-dione H


MM0328.02 1162-56-7 100mg
( 6-Progesterone) H H
O

MM0328.02- Impurity B (EP): Pregna-4,6-diene-3,20-dione H


1162-56-7 25mg
0025 ( 6-Progesterone) H H
O

Dyphylline, see Diprophylline

Ebastine
MM0468.00-
Ebastine 90729-43-4 250mg O
N
O

0250
OH

MM0490.02 Impurity A (EP): Diphenylmethanol (Benzhydrol) 91-01-0 100mg

OH
MM0490.02-
Impurity A (EP): Diphenylmethanol (Benzhydrol) 91-01-0 25mg
0025

Impurity B (EP): 1-[4-(1,1-Dimethylethyl)phenyl]-


ethanone
Related compound B (USP): 1-[4-(Dimethylethyl)phenyl]
MM0468.03 943-27-1 100mg
ethanone O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-209
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity C (EP) as Hydrochloride: 4-(Diphenyl-


NH
MM0468.04 methoxy)piperidine Hydrochloride 65214-86-0 100mg O
HCl

Related compound C (USP): 4-(diphenylmethoxy)piperidine

Impurity C (EP) as Hydrochloride: 4-(Diphenyl-


MM0468.04- NH
methoxy)piperidine Hydrochloride 65214-86-0 25mg O
HCl

0025 Related compound C (USP): 4-(diphenylmethoxy)piperidine


Impurity D (EP): 1-[4-(1,1-Dimethylethyl)phenyl]-
4-(4-hydroxypiperidin-1-yl)butan-1-one
MM0468.05 N
Related compound D (USP): 1-[4-(1,1-Dimethylethyl)
97928-18-2 100mg
O
HO

phenyl]-4-(4-hydroxypiperidin-1-yl)butan-1-one
Impurity D (EP): 1-[4-(1,1-Dimethylethyl)phenyl]-
MM0468.05- 4-(4-hydroxypiperidin-1-yl)butan-1-one
N
Related compound D (USP): 1-[4-(1,1-Dimethylethyl)
97928-18-2 25mg
0025 O
HO

phenyl]-4-(4-hydroxypiperidin-1-yl)butan-1-one
Impurity E (EP) as Hydrogen Fumarate: 1-[4-(1,1-
MM0468.06- Dimethylpropyl)phenyl]-4-[4-(diphenylmethoxy)- N

piperidin-1-yl]butan-1-one Hydrogen Fumarate n/a 25mg O


O
O
HO
0025 Related compound E (USP): 1-[4-(1,1-Dimethylpropyl) O
OH

phenyl]-4-[4-(diphenylmethoxy)piperidin-1-yl]-butan-1-one
Mixture of Impurity F and G (EP): Ebastine N-Oxide (cis O
N
+

MM0468.09 1256285-71-8 50mg


and trans)
O
O

Ecamsule

[(1RS,4SR)-7,7-Dimethyl-2-oxobicyclo[2.2.1]hept-1-yl] AND Enantiomer


O O
MM1094.07- S
methanesulfonic Acid ((±)-10-Camphorsulfonic Acid) OH
5872-08-2 25mg O
0025 Related compound D (USP): ((1SR,4RS)-7,7-dimethyl-2-
oxobicyclo[2.2.1]heptan-1-yl)methanesulfonic acid

Echinomycin
N

MM3695.01 Methyl Quinoxaline-2-carboxylate 1865-11-8 100mg N


O

N
MM3695.01-
Methyl Quinoxaline-2-carboxylate 1865-11-8 25mg N
O
0025 O

Econazole
Cl

Cl
MM3432.00 Econazole 27220-47-9 250mg
O
N
Cl
N

Econazole Nitrate
Cl

O
MM0524.00- Cl
Econazole Nitrate 24169-02-6 250mg O
HO N
+

O
0250 Cl
N

Impurity A (EP): (1RS)-1-(2,4-


Dichlorophenyl)-2-(1H-imidazol-1-yl)- Cl

MM0281.01 ethanol 24155-42-8 100mg N


N
Related compound A (USP): 1-(2,4-Dichlorophenyl)-2-(1H- Cl OH

imidazole-1-yl)ethanol

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-210
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP): (1RS)-1-(2,4-


MM0281.01- Dichlorophenyl)-2-(1H-imidazol-1-yl)- Cl

ethanol 24155-42-8 25mg N


N
0025 Related compound A (USP): 1-(2,4-Dichlorophenyl)-2-(1H- Cl OH

imidazole-1-yl)ethanol
Impurity B (EP) as Nitrate: (2RS)-2-[(4- Cl

Chlorobenzyl)oxy]-2-(2,4-
MM0524.02 dichlorophenyl)ethanamine Nitrate n/a 100mg Cl
HO N
O
+

O
Related compound B (USP): 2-[(4-Chlorobenzyl)oxy]-2-(2,4- Cl
N H2
O

dichlorophenyl)ethanamine
Impurity B (EP) as Nitrate: (2RS)-2-[(4- Cl

MM0524.02- Chlorobenzyl)oxy]-2-(2,4-
dichlorophenyl)ethanamine Nitrate n/a 25mg Cl
HO N
O
+

O
0025 Related compound B (USP): 2-[(4-Chlorobenzyl)oxy]-2-(2,4- Cl
N H2
O

dichlorophenyl)ethanamine
Impurity C (EP) as Chloride: 1-(4-Chlorobenzyl)-3- Cl

[(2RS)-2-[(4-chlorobenzyl)oxy]-2-(2,4-dichloro- Cl

MM0524.03 phenyl)ethyl]imidazolium Chloride n/a 100mg O


N
+ Cl
Cl
Related compound C (USP): 1-(4-Chlorobenzyl)-3-[(2RS)-2- N
Cl

[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]imidazolium
Impurity C (EP) as Chloride: 1-(4-Chlorobenzyl)-3- Cl

MM0524.03- [(2RS)-2-[(4-chlorobenzyl)oxy]-2-(2,4-dichloro- Cl

phenyl)ethyl]imidazolium Chloride n/a 25mg O


N
+ Cl
Cl
0025 Related compound C (USP): 1-(4-Chlorobenzyl)-3-[(2RS)-2- N
Cl

[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]imidazolium

Edaravone

O
Edaravone (5-Methyl-2-phenyl-2,4-dihydro-3H-pyrazol-3- N
MM0036.01 89-25-8 100mg
one) N

Edoxaban
N N
O
S O
HN

MM3366.00 Edoxaban 480449-70-5 100mg HN


N

H
N N
O
O
Cl

Efavirenz
H
N O

O
Cl
MM0919.00 Efavirenz 154598-52-4 250mg F
F
F

O
H
N

MM0919.02- (S)-5-Chloro-a-(2-cyclopropylethynyl)-2-[[(4-methoxyphenyl) Cl
OH
173676-60-3 25mg F
0025 methyl]amino]-a-(trifluoro-methyl)benzenemethanol F
F

N H2
(S)-2-(2-Amino-5-chlorophenyl)-4-cyclopropyl-1,1,1-
OH
Cl
trifluorobut-3-yn-2-ol F
MM0919.03 209414-27-7 100mg F
Related compound A (USP): (S)-2-(2-amino-5-chlorophenyl)- F

4-cyclopropyl-1,1,1-trifluorobut-3-yn-2-ol
N H2
(S)-2-(2-Amino-5-chlorophenyl)-4-cyclopropyl-1,1,1-
OH
Cl
MM0919.03- trifluorobut-3-yn-2-ol F
209414-27-7 25mg F
0025 Related compound A (USP): (S)-2-(2-amino-5-chlorophenyl)- F

4-cyclopropyl-1,1,1-trifluorobut-3-yn-2-ol

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-211
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N
6-Chloro-2-cyclopropyl-4-(trifluoromethyl)quinoline
MM0919.05 Related compound C (USP): 6-chloro-2-cyclopropyl-4- 391860-73-4 100mg Cl
F
(trifluoromethyl)quinoline F
F

N
6-Chloro-2-cyclopropyl-4-(trifluoromethyl)quinoline
MM0919.05-
Related compound C (USP): 6-chloro-2-cyclopropyl-4- 391860-73-4 25mg Cl
0025 F
(trifluoromethyl)quinoline F
F

H
N O

O
MM0919.06- Cl
F
Efavirenz Racemic 177530-93-7 25mg
0025 F
F

O
H
N

MM0919.07 N-(4-Methoxybenzyl)-4-chloro-2-(trifluoroacetyl)aniline 173676-54-5 100mg O


Cl
F
F
F

O
H
N
MM0919.07-
N-(4-Methoxybenzyl)-4-chloro-2-(trifluoroacetyl)aniline 173676-54-5 25mg O
Cl
0025 F
F
F

N H2

MM0919.08- O
1-(2-Amino-5-chlorophenyl)-2,2,2-trifluoroethanone 154598-53-5 25mg Cl
0025 F
F
F

Eletriptan Hydrobromide
H
N

MM3542.00 Eletriptan Hydrobromide 177834-92-3 250mg O


S
O
N
HBr

Eliglustat Tartrate
N
H
N
MM3942.00- O
Eliglustat 491833-29-5 250mg HO

0250 O
O

Elvitegravir
O O F
Cl
HO

MM3372.00 Elvitegravir 697761-98-1 100mg HO


N O

O O
I
O
MM3372.07- Ethyl 7-Fluoro-1-((2S)-1-hydroxy-3-methylbutan-2-yl)-6-iodo-
697762-60-0 25mg N F
0025 4-oxo-1,4-dihydroquinoline-3-carboxylate HO

Embutramide
O

MM3065.00 Embutramide 15687-14-6 50mg HN


OH
O

Emedastine Difumarate
O
N

MM1277.00 Emedastine Difumarate 87233-62-3 250mg N

N
N
HO

O
O

OH

O
O
+
N
MM1277.09- N N
O

Emedastine N-Oxide Difumarate n/a 25mg HO


OH
N
0025 O
2

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-212
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Empagliflozin
Cl O

MM3780.00- O

Empagliflozin
O
HO
864070-44-0 250mg HO OH
0250 OH

Emtricitabine
F
H 2N

MM1325.00 Emtricitabine 143491-57-0 100mg N N O

O S OH

N H2
F
N
Emtricitabine L-Menthyl Ester ((2R,5S)-5-(4-Amino-5-fluoro-2-
O N
MM1325.01 oxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid 764659-72-5 100mg O
(1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester) S
O
O

N H2
F
N
Emtricitabine L-Menthyl Ester ((2R,5S)-5-(4-Amino-5-fluoro-2-
MM1325.01- O N
oxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid 764659-72-5 25mg O
0025
(1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester) S
O
O

NH2
F
N

O N
MM1325.02 Emtricitabine Sulfoxide 152128-77-3 100mg
O
S
O
HO

NH2
F
N

MM1325.02- O N
Emtricitabine Sulfoxide 152128-77-3 25mg
0025 O
S
O
HO

NH2
F
N

MM1325.03- O N
Emtricitabine Sulfone 1161846-23-6 25mg
0025
O
S
O
O
HO

HN
F
N
MM1325.04-
N-Acetylemtricitabine n/a 25mg O N
0025
O
S

HO

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-213
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N H2
F
N

O N
MM1325.05-
O-Acetylemtricitabine 145032-08-2 25mg O
0025
S

O
O

HN
F
N

O N
MM1325.06-
N,O-Diacetylemtricitabine n/a 25mg
0025 O
S

O
O

O
MM1325.08- (2R,5S)-5-Acetyloxy-1,3-oxathiolane-2-carboxylic Acid
147126-65-6 25mg O
0025 (1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester S
O
O

NH2
F
N

O N
MM1325.09-
O-Formylemtricitabine n/a 25mg O
0025
S

NH2
F
N
MM0355.00 Flucytosine 2022-85-7 250mg
O N
H

Emylcamate
O
MM3364.00 Emylcamate 78-28-4 50mg
O NH2

Enalapril Maleate
O
O OH O
H
MM0010.00- N

Enalapril Maleate 76095-16-4 250mg O O


N OH
OH

0250 O

O
H
Impurity B (EP): (2S)-2-[[(1S)-1-(Ethoxycarbonyl)- N
OH
MM0010.05 82717-96-2 100mg
3-phenylpropyl]amino]propanoic Acid O O

O
H
MM0010.05- Impurity B (EP): (2S)-2-[[(1S)-1-(Ethoxycarbonyl)- N
OH
82717-96-2 25mg
0025 3-phenylpropyl]amino]propanoic Acid O O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-214
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity C (EP): (2S)-1-[(2S)-2-[[(1S)-1-Carboxy- H


O
O
OH

MM0010.01 3-phenylpropyl]amino]propanoyl]pyrrolidine-2- 76420-72-9 100mg N


N

carboxylic Acid (Enalaprilat) O OH

Impurity D (EP): Ethyl (2S)-2-[(3S,8aS)-3-Methyl-


H
1,4-dioxo-octahydropyrrolo[1,2-a]pyrazin-2-yl]- O
N
4-phenylbutanoate (Enalapril Diketopiperazine) N
O

Related compound D (USP): (S)-Ethyl 2-[(3S,8aS)-3-methyl-


MM0010.06 115729-52-7 100mg
O O

1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)-yl]-4-
phenylbutanoate
Impurity D (EP): Ethyl (2S)-2-[(3S,8aS)-3-Methyl-
H
1,4-dioxo-octahydropyrrolo[1,2-a]pyrazin-2-yl]- O
N
MM0010.06- 4-phenylbutanoate (Enalapril Diketopiperazine) N
O

Related compound D (USP): (S)-Ethyl 2-[(3S,8aS)-3-methyl-


115729-52-7 25mg
0025 O O

1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)-yl]-4-
phenylbutanoate
H
N
MM0015.02 Impurity I (EP): 1H-Imidazole (Imidazole) 288-32-4 100mg
N

(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3- H
N
O

O
MM0010.15 phenylpropyl]amino]propanoic Acid n/a 100mg O O
HCl
Ethyl Ester Hydrochloride

MM0010.15- (2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3- H
N
O

O
phenylpropyl]amino]propanoic Acid n/a 25mg O O
HCl
0025 Ethyl Ester Hydrochloride
O
O O
H
Enalapril Ethyl Ester (N-[(1S)-1-(Ethoxycarbonyl)-3- N
N
MM0010.17 87420-38-0 100mg O O
phenylpropyl]-L-alanyl-L-proline Ethyl Ester)

OH
MM0010.20 Hydrocinnamic Acid (3-Phenylpropanoic Acid) 501-52-0 100mg
O

O
O OH
MM0010.27- (2S)-1-[(2S)-2-Aminopropanoyl]pyrrolidine-2-carboxylic Acid H2 N
13485-59-1 25mg N
0025 (L-Alanyl-L-proline)

Enilconazole
Cl

Cl
MM1228.00 Enilconazole 35554-44-0 250mg
O
N

Cl
Impurity E (EP): (1RS)-1-(2,4-Dichlorophenyl)-
MM0281.01 24155-42-8 100mg N
2-(1H-imidazol-1-yl)ethanol Cl OH
N

Cl
MM0281.01- Impurity E (EP): (1RS)-1-(2,4-Dichlorophenyl)-
24155-42-8 25mg N
0025 2-(1H-imidazol-1-yl)ethanol Cl OH
N

Enoxacin Sesquihydrate
HN
N N N

Enoxacin Sesquihydrate
H2 O
3
MM3662.00 84294-96-2 250mg F
OH

O O
2

Enoxolone
O
OH

H
O
MM3399.00 Enoxolone 471-53-4 250mg
H
HO
H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-215
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Enrofloxacin
N
N N

MM0395.00 Enrofloxacin 93106-60-6 100mg OH


F
O O

Impurity A (EP): 7-Chloro-1-cyclopropyl-6-fluoro- Cl N


MM0018.01 86393-33-1 100mg
4-oxo-1,4-dihydroquinoline-3-carboxylic Acid F
OH

O O

MM0018.01- Impurity A (EP): 7-Chloro-1-cyclopropyl-6-fluoro- Cl N


86393-33-1 25mg
0025 4-oxo-1,4-dihydroquinoline-3-carboxylic Acid F
OH

O O

HN

Impurity B (EP) as Hydrochloride Monohydrate: N N


MM0018.06 86393-32-0 500mg HCl
Ciprofloxacin Hydrochloride Monohydrate H2 O
F
OH

O O

Impurity C (EP) as Hydrochloride: 1-Cyclopropyl- N HCl


7-(4-ethylpiperazin-1-yl)-4-oxo-1,4-dihydro- N N

MM0395.01 n/a 100mg


quinoline-3-carboxylic Acid Hydrochloride O O
OH

(Desfluoroenrofloxacin Hydrochloride)
Impurity C (EP) as Hydrochloride: 1-Cyclopropyl- N HCl
MM0395.01- 7-(4-ethylpiperazin-1-yl)-4-oxo-1,4-dihydro- N N

n/a 25mg
0025 quinoline-3-carboxylic Acid Hydrochloride O O
OH

(Desfluoroenrofloxacin Hydrochloride)

Impurity G (EP): 7-[(2-Aminoethyl)amino]-1-cyclopropyl- H 2N


H
N N

MM0018.04 103222-12-4 50mg


6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid F
O O
OH

O
+
N HCl
N N
MM0395.07 Enrofloxacin N-Oxide Hydrochloride n/a 100mg OH
F
O O

N
MM0395.06 N-Ethylpiperazine 5308-25-8 100mg NH

N
MM0395.11- N N

Enrofloxacin Methyl Ester 107884-20-8 25mg F


O
0025 O O

N
MM0395.12- N N

Enrofloxacin Ethyl Ester 107884-19-5 25mg F


O
0025 O O

N
MM0395.13- N N

Enrofloxacin Isopropyl Ester n/a 25mg F


O
0025 O O

Ensulizole
H
N

MM1571.00 Ensulizole 27503-81-7 250mg HO


S N
O O

Entacapone
O O
+
N
O N
MM1221.00 Entacapone 130929-57-6 250mg HO
N
OH

Impurity A (EP): (2Z)-2-Cyano-3-(3,4-dihydroxy- HO


N

MM1221.02- 5-nitrophenyl)-N,N-diethylprop-2-enamide
HO O N
Related compound A (USP): (Z)-2-cyano-3-(3,4-dihydroxy-
145195-63-7 25mg
0025 +
N
O O
5-nitrophenyl)-N,N-diethylacrylamide
O O
+
MM1221.04- Impurity B (EP): Ethyl (2E)-2-Cyano-3-(3,4- O
N
O
1215039-66-9 25mg
0025 dihydroxy-5-nitrophenyl)prop-2-enoate HO
OH
N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-216
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
HO

MM1221.01 Impurity C (EP): 3,4-Dihydroxy-5-nitrobenzaldehyde 116313-85-0 100mg


HO
+
N
O O

O
HO
MM1221.01-
Impurity C (EP): 3,4-Dihydroxy-5-nitrobenzaldehyde 116313-85-0 25mg
0025 HO
+
N
O O
O O

MM1221.05- Impurity D (EP): (2E)-2-Cyano-3-(3-ethoxy-4- O


N
+
N

hydroxy-5-nitrophenyl)-N,N-diethylprop-2- 857629-79-9 25mg HO


N
O
0025 enamide
O O
+ +
N N
MM1221.06- O O
Impurity E (EP): 3,5-Dinitrobenzene-1,2-diol 7659-29-2 25mg
0025 HO
OH

O O
+
N
MM1221.07- Impurity F (EP): (2E)-2-Cyano-3-(3,4-dihydroxy- O OH
160391-70-8 25mg
0025 5-nitrophenyl)prop-2-enoic Acid HO
N
OH

O O
+
MM1221.08- Impurity G (EP): (2E)-2-Cyano-3-(3,4-dihydroxy- O
N
N
H
n/a 25mg
0025 5-nitrophenyl)-N-methylprop-2-enamide HO
N
OH

Impurity H (EP): (2E)-3-(3,4-Dihydroxy-5-nitro- O


N
+
O

O N
MM1221.03 phenyl)-2-(piperidin-1-ylcarbonyl)prop-2- 1150310-15-8 50mg HO

ennitrile OH
N

O O

MM1221.09- Impurity I (EP): Propyl (2E)-2-Cyano-3-(3,4- O


N
+

O
1364322-42-8 25mg
0025 dihydroxy-5-nitrophenyl)prop-2-enoate HO
OH
N

Entecavir Monohydrate
O

N
HN
H2 O
H 2N N N
MM3314.00 Entecavir Monohydrate 209216-23-9 250mg
HO
HO

N
Impurity D (EP): 2-Amino-9-[(1S,3R,4R)-4-hydroxy-3- HN
MM3314.07- H 2N N N
(hydroxymethyl)-2-methylidenecyclopentyl]-1,9-dihydro-6H- 1367369-80-9 25mg
0025 OH
purin-6-one
HO

N
HN

HN N N
H
MM3314.01 Entecavir N2-Isomer n/a 5mg

HO
HO

N
HN

MM3314.02- H 2N N N

3',5'-Di-O-Benzylentecavir 142217-81-0 25mg


0025
O O

N-[(4-Methoxyphenyl)diphenylmethyl]-9-[(1S,3R,4S)-2- O
MM3314.16- N
N

methylene-4-(phenylmethoxy)-3-[(phenylmethoxy)methyl] 142217-80-9 25mg N


H
N N

0025
cyclopentyl]-6-(phenylmethoxy)-9H-purin-2-amine O
O
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-217
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Enzalutamide
F
F
O F F
N
MM3917.00- N
H
S

Enzalutamide 915087-33-1 250mg N N


0250 O

Ephedrine Hydrochloride
OH
H
MM0652.00- N
Ephedrine Hydrochloride 50-98-6 250mg HCl

0250
Impurity B (EP) as Hydrochloride: (1S,2S)-2- OH
MM2115.00- NH HCl
(Methylamino)-1-phenylpropan-1-ol Hydro- 345-78-8 250mg
0250 chloride (Pseudoephedrine Hydrochloride)
OH
H
N HCl
MM0652.03 (1S,2R)-(+)-Ephedrine Hydrochloride 24221-86-1 100mg

OH
H
MM0652.03- N HCl
(1S,2R)-(+)-Ephedrine Hydrochloride 24221-86-1 25mg
0025
OH
N
MM0652.04 Methylephedrine ((1R,2S)-Methylephedrine) 552-79-4 100mg

OH
MM0652.04- N
Methylephedrine ((1R,2S)-Methylephedrine) 552-79-4 25mg
0025

OH O
+
N
MM0652.05 2-Nitro-1-phenyl-1-propanol 6343-57-3 100mg O

Ephedrine Hydrochloride racemic


AND Enantiomer
OH
H
MM1979.00 Ephedrine Hydrochloride racemic 134-71-4 250mg N HCl

Ephedrine Sulphate
OH
H O
N
MM1147.00 Ephedrine Sulphate 134-72-5 250mg HO
O
S OH

Epinastine Hydrochloride
N
NH2

N
MM3383.00 Epinastine Hydrochloride 108929-04-0 250mg HCl

Epinephrine Bitartrate, see Adrenaline Tartrate

Epirubicin Hydrochloride
O OH O
OH
OH

MM0307.00 Epirubicin Hydrochloride 56390-09-1 100mg O O OH


O
O HCl

NH2
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-218
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O OH
O
OH
MM0283.01-
Impurity A (EP): Doxorubicinone 24385-10-2 25mg OH

0025 O O OH OH

O OH O
OH
OH

Impurity C (EP) as Hydrochloride: Doxorubicin O O OH O HCl


MM0283.00 25316-40-9 100mg
Hydrochloride O

NH2
OH

O OH O

OH

Impurity D (EP) as Hydrochloride: Daunorubicin O O OH O HCl


MM0284.00 23541-50-6 250mg
Hydrochloride O

NH2
OH

Eplerenone
O

O H
MM3530.00 Eplerenone 107724-20-9 250mg H
O
O
O

Eprosartan Mesilate
O O O
S
OH OH

O
MM1577.00 Eprosartan Mesilate 144143-96-4 250mg HO
N

S N

O O
2-(Thiophen-2-ylmethyl)malonic Acid
MM1577.01- HO OH
Related compound C (USP): 2-(thiophen-2-ylmethyl)malonic 4475-24-5 25mg S
0025
acid

3-(Thiophen-2-yl)propanoic Acid HO
MM1577.02 5928-51-8 100mg
Related compound B (USP): 3-(thiophen-2-yl)propanoic acid S

MM1577.02- 3-(Thiophen-2-yl)propanoic Acid HO


5928-51-8 25mg S
0025 Related compound B (USP): 3-(thiophen-2-yl)propanoic acid

Eptifibatide
HN N H2 NH
O
HN H
O N O O
N
H O
OH N OH
MM3543.01 Eptifibatide Acetate 881997-86-0 100mg HN

O
O
NH
N H2
HN S S O
O

Equilin
O

MM1240.00 Equilin 474-86-2 100mg


H H
HO

Erdosteine
O
S
MM0544.00- O O
Erdosteine 84611-23-4 250mg N
S
OH
0250 H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-219
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
S
O
MM0544.01- 2-Chloro-N-(2-oxotetrahydrothiophen-3-
Cl
yl)acetamide
84611-22-3 25mg
0025 N
H

O
S
O O
MM0544.02 Erdosteine Methyl Ester 1667709-77-4 100mg S
N O
H

O
S
MM0544.02- O O

Erdosteine Methyl Ester 1667709-77-4 25mg S


N O
0025 H

O
S
MM0544.03- O O

Erdosteine Ethyl Ester 84611-37-0 25mg S


N O
0025 H

O
S
MM0544.04- O O

Erdosteine Isopropyl Ester 2732347-39-4 25mg S


N O
0025 H

O O
Methyl 2-[[2-(2-Methoxy-2-oxoethyl)sulfanylacetyl]amino]-4- O O
S
MM0544.05 n/a 100mg HS N
H
O
sulfanylbutanoate
O O
Ethyl 2-[[2-(2-Ethoxy-2-oxo-ethyl)sulfanylacetyl]amino]-4- O O
S
MM0544.06 n/a 100mg HS N
H
O

sulfanylbutanoate
O
S
MM0544.08- O O O
Erdosteine Sulfoxide n/a 25mg S
N OH
0025 H

Ergocalciferol

MM1511.00 Ergocalciferol 50-14-6 250mg H

HO

MM1511.01 Impurity B (EP): (22E)-Ergosta-5,7,22-trien-3 -ol (Ergosterol) 57-87-4 100mg H H


HO

MM1511.01- H

Impurity B (EP): (22E)-Ergosta-5,7,22-trien-3 -ol (Ergosterol) 57-87-4 25mg H H


0025 HO

Ergometrine Maleate (Ergonovine Maleate)


O
H
N
OH

MM1385.00 Ergometrine Maleate 129-51-1 100mg HN H


N
OH
OH

O O

HO N
H
Impurity A (EP): (8 )-6-Methyl-9,10-didehydroergoline-8-
MM1346.03 82-58-6 100mg
carboxylic Acid (Lysergic Acid)
N
H

HO N
H
MM1346.03- Impurity A (EP): (8 )-6-Methyl-9,10-didehydroergoline-8-
82-58-6 25mg
0025 carboxylic Acid (Lysergic Acid)
N
H

Ergonovine Maleate, see Ergometrine Maleate

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-220
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Ergotamine Tartrate
H
N

HN OH
MM0097.06 Lysergol 602-85-7 100mg

H
N
MM0097.06- HN
Lysergol 602-85-7 25mg OH
0025

Erlotinib Hydrochloride
O N
O
O N

MM3297.00 Erlotinib Hydrochloride 183319-69-9 250mg


O
HN
HCl

O N
O
O N
MM3297.01 4-Chloro-6,7-bis(2-methoxyethoxy)quinazoline 183322-18-1 100mg O
Cl

O N
O
MM3297.01- O N
4-Chloro-6,7-bis(2-methoxyethoxy)quinazoline 183322-18-1 25mg O
0025 Cl

O N
O
O NH
MM3297.02 6,7-Bis(2-methoxyethoxy)-3H-quinazolin-4-one 179688-29-0 100mg O
O

O N
O
MM3297.02- O NH
6,7-Bis(2-methoxyethoxy)-3H-quinazolin-4-one 179688-29-0 25mg O
0025 O

O NH2
O
MM3297.04- 2-Amino-4,5-bis(2-methoxyethoxy)benzoic Acid Ethyl Ester HCl
O O
183322-17-0 25mg O
O
0025 Hydrochloride
O
MM3297.05- O

3,4-Bis(2-methoxyethoxy)benzonitrile 80407-68-7 25mg O


O
0025 N

O
MM3297.06- O
3,4-Bis(2-methoxyethoxy)benzaldehyde 80407-64-3 100mg O O
0100 O

O
+
MM3297.07- O N
O O
4,5-Bis(2-methoxyethoxy)-2-nitrobenzonitrile 236750-65-5 25mg O
0025 O
N

OH

MM3297.08- H2 N
4-(3-Aminophenyl)-2-methylbut-3-yn-2-ol 69088-96-6 25mg
0025

O
O
MM3297.09- O O
3,4-Bis(2-methoxyethoxy)benzoic Acid Ethyl Ester 183322-16-9 25mg O
0025 O

HO
MM3297.10-
3,4-Dihydroxybenzaldehyde 139-85-5 25mg O
0025 HO

O NH2
MM3297.13- O
2-Amino-4,5-bis(2-methoxyethoxy)benzonitrile 950596-58-4 25mg O
O
0025 N

O N
O
O N
MM3297.19- N-(4-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4- O
HN
1029721-32-1 25mg
0025 quinazolinamine
O N
O
MM3297.17- O N
O
4-(1,1-Dimethylethoxy)-6,7-bis(2-methoxyethoxy)quinazoline 1683583-42-7 25mg O
0025
O N
O
MM3297.16- O N
O
6,7-Bis(2-methoxyethoxy)-4-(1-methylethoxy)quinazoline 1683583-39-2 25mg O
0025
O N
O
MM3297.18- O N
6,7-Bis(2-methoxyethoxy)-4-quinazolinamine 1417161-98-8 25mg O
0025 N H2

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-221
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Erythritol
OH

MM3559.00 Erythritol 149-32-6 250mg HO OH


OH

OH
HO OH
O
Impurity A (EP): 4-O- -D-Glucopyranosyl-D-glucitol (D- HO O
MM3570.00 585-88-6 250mg OH
Maltitol) HO OH
HO
OH

OH
OH
HO
MM1492.00 Impurity B (EP): D-Glucitol (D-Sorbitol, Sorbitol) 50-70-4 250mg OH
OH
HO

Erythromycin

Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O

[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH

oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- O O
MM0132.13 992-62-1 100mg
[[3,4,6-trideoxy-3-(methylamino)- -D-xylo-hexopyranosyl]oxy] N
H
OH
O
O O

oxacyclotetradecane-2,10-dione (3''-N- HO
O

Desmethylerythromycin A; N-Demethylerythromycin A)

Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O

[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH

MM0132.13- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- O O
992-62-1 25mg
0025 [[3,4,6-trideoxy-3-(methylamino)- -D-xylo-hexopyranosyl]oxy] N
H
OH
O
O O

oxacyclotetradecane-2,10-dione (3''-N- HO
O

Desmethylerythromycin A; N-Demethylerythromycin A)

Impurity D (EP):
OH
(1S,2R,3R,4S,5R,8R,9S,10S,11R,12R,14R)-9-[(2,6-Dideoxy-
O

MM0132.09- 3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]-5-ethyl- O


O O
O

3-hydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3- 23893-13-2 25mg N OH


O
O O

0025 (dimethylamino)- -D-xylo-hexopyranosyl]oxy]-6,15,16- HO

trioxatricyclo[10.2.1.11,4]hexadecan-7-one
O

(Anhydroerythromycin A)
Impurity E (EP): (2R,3R,4S,5R,8R,9S,10S,11R,12R)-9-[(2,6-
Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]- O
O
HO
OH

MM0132.10- 5-ethyl-3,4-dihydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6- O O
33396-29-1 25mg
0025 trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl]oxy]- N OH O
O
O

6,15-dioxabicyclo[10.2.1]pentadec-1(14)-en-7-one HO
O

(Erythromycin A Enol Ether)


Impurity H (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O

N [(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH

MM0132.18- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- +
O O
e 992-65-4 25mg
0025 [[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl] N
O
OH
O
O O

oxy]oxacyclotetradecane-2,10-dione N-Oxide (Erythromycin A


w
HO
O

3''-N-Oxide; Erythromycin A N-Oxide)


Impurity J (EP) as (1S)-Isomer: OH

(1S,2R,3R,6R,7S,8S,9R,10R,12R)-7-[(2,6-Dideoxy-3-C- O OH

methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]-3-[(1R,2R)- O
H

O
O HO
MM0132.25 1,2-dihydroxy-1-methylbutyl]-1-hydroxy-2,6,8,10,12- 105900-46-7 50mg N OH O
O
O

pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-
HO
hexopyranosyl]oxy]-4,13-dioxabicyclo[8.2.1]tridecan-5-one O

(Pseudoerythromycin A Hemiketal)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-222
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Erythromycin Estolate
Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O

[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH

oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- O O
MM0132.13 992-62-1 100mg
[[3,4,6-trideoxy-3-(methylamino)- -D-xylo-hexopyranosyl]oxy] N
H
OH
O
O O

oxacyclotetradecane-2,10-dione (3''-N- HO
O

Desmethylerythromycin A; N-Demethylerythromycin A)
Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O

[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH

MM0132.13- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- O O
992-62-1 25mg
0025 [[3,4,6-trideoxy-3-(methylamino)- -D-xylo-hexopyranosyl]oxy] N
H
OH
O
O O

oxacyclotetradecane-2,10-dione (3''-N- HO
O

Desmethylerythromycin A; N-Demethylerythromycin A)
Impurity D (EP):
OH
(1S,2R,3R,4S,5R,8R,9S,10S,11R,12R,14R)-9-[(2,6-Dideoxy-
O

MM0132.09- 3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]-5-ethyl- O


O O
O

3-hydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3- 23893-13-2 25mg N OH


O
O O

0025 (dimethylamino)- -D-xylo-hexopyranosyl]oxy]-6,15,16- HO

trioxatricyclo[10.2.1.11,4]hexadecan-7-one
O

(Anhydroerythromycin A)
Impurity E (EP): (2R,3R,4S,5R,8R,9S,10S,11R,12R)-9-[(2,6-
Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]- O
O
HO
OH

MM0132.10- 5-ethyl-3,4-dihydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6- O O
33396-29-1 25mg
0025 trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl]oxy]- N OH O
O
O

6,15-dioxabicyclo[10.2.1]pentadec-1(14)-en-7-one HO
O

(Erythromycin A Enol Ether)


Impurity H (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O

N [(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH

e
MM0132.18- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- +
O O
992-65-4 25mg
0025 [[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl] N
O
OH
O
O O

oxy]oxacyclotetradecane-2,10-dione N-Oxide (Erythromycin A


w
HO
O

3''-N-Oxide; Erythromycin A N-Oxide)


Impurity J (EP) as (1S)-Isomer: OH

(1S,2R,3R,6R,7S,8S,9R,10R,12R)-7-[(2,6-Dideoxy-3-C- O OH

methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]-3-[(1R,2R)- O
H

O
O HO
MM0132.25 1,2-dihydroxy-1-methylbutyl]-1-hydroxy-2,6,8,10,12- 105900-46-7 50mg N OH O
O
O

pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-
HO
hexopyranosyl]oxy]-4,13-dioxabicyclo[8.2.1]tridecan-5-one O

(Pseudoerythromycin A Hemiketal)

Erythromycin Ethylsuccinate
Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O

[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo- OH
O HO HO

hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy- O O
MM0132.13 992-62-1 100mg N
H
OH O O
3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(methylamino)- O

HO
-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione O

(3''-N-Desmethylerythromycin A; N-Demethylerythromycin A)
Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O

[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo- OH
O HO HO

MM0132.13- hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy- O O
992-62-1 25mg N
H
OH O O
0025 3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(methylamino)- O

HO
-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione O

(3''-N-Desmethylerythromycin A; N-Demethylerythromycin A)
Impurity D (EP): (1S,2R,3R,4S,5R,8R,9S,10S,11R,12R,14R)-
OH

9-[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo- O
O O
O O
MM0132.09- hexopyranosyl)oxy]-5-ethyl-3-hydroxy-2,4,8,10,12,14-
23893-13-2 25mg N OH O O
O
0025 hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-
HO
O
hexopyranosyl]oxy]-6,15,16-trioxatricyclo[10.2.1.11,4]
hexadecan-7-one (Anhydroerythromycin A)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-223
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity E (EP): (2R,3R,4S,5R,8R,9S,10S,11R,12R)-9-[(2,6-


Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]- O OH
O HO

MM0132.10- 5-ethyl-3,4-dihydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6- O O
33396-29-1 25mg N OH O O
0025 trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl]oxy]- O

HO
6,15-dioxabicyclo[10.2.1]pentadec-1(14)-en-7-one O

(Erythromycin A enol ether)

Erythromycin Lactobionate

Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O

[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH

oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- O O
MM0132.13 992-62-1 100mg
[[3,4,6-trideoxy-3-(methylamino)- -D-xylo-hexopyranosyl]oxy] N
H
OH
O
O O

oxacyclotetradecane-2,10-dione (3''-N- HO
O

Desmethylerythromycin A; N-Demethylerythromycin A)

Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O

[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH

MM0132.13- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- O O
992-62-1 25mg
0025 [[3,4,6-trideoxy-3-(methylamino)- -D-xylo-hexopyranosyl]oxy] N
H
OH
O
O O

oxacyclotetradecane-2,10-dione (3''-N- HO
O

Desmethylerythromycin A; N-Demethylerythromycin A)

Impurity D (EP):
OH
(1S,2R,3R,4S,5R,8R,9S,10S,11R,12R,14R)-9-[(2,6-Dideoxy-
O

MM0132.09- 3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]-5-ethyl- O


O O
O

3-hydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3- 23893-13-2 25mg N OH


O
O O

0025 (dimethylamino)- -D-xylo-hexopyranosyl]oxy]-6,15,16- HO

trioxatricyclo[10.2.1.11,4]hexadecan-7-one
O

(Anhydroerythromycin A)
Impurity E (EP): (2R,3R,4S,5R,8R,9S,10S,11R,12R)-9-[(2,6-
Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]- O
O
HO
OH

MM0132.10- 5-ethyl-3,4-dihydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6- O O
33396-29-1 25mg
0025 trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl]oxy]- N OH O
O
O

6,15-dioxabicyclo[10.2.1]pentadec-1(14)-en-7-one HO
O

(Erythromycin A Enol Ether)


Impurity H (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O

N [(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH

MM0132.18- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- +
O O
e 992-65-4 25mg
0025 [[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl] N
O
OH
O
O O

oxy]oxacyclotetradecane-2,10-dione N-Oxide (Erythromycin A


w
HO
O

3''-N-Oxide; Erythromycin A N-Oxide)


Impurity J (EP) as (1S)-Isomer: OH

(1S,2R,3R,6R,7S,8S,9R,10R,12R)-7-[(2,6-Dideoxy-3-C- O OH

methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]-3-[(1R,2R)- O
H

O
O HO
MM0132.25 1,2-dihydroxy-1-methylbutyl]-1-hydroxy-2,6,8,10,12- 105900-46-7 50mg N OH O
O
O

pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-
HO
hexopyranosyl]oxy]-4,13-dioxabicyclo[8.2.1]tridecan-5-one O

(Pseudoerythromycin A Hemiketal)

Erythromycin Stearate
Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-
O
[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-
OH
hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy- O HO HO

O O
MM0132.13 3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(methylamino)- 992-62-1 100mg N
H
OH O O
O

-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione HO
O
(3''-N-Desmethylerythromycin A; N-Demethylerythromycin A)
Related compound N (USP): N-Demethylerythromycin A

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-224
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-


O
[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-
OH
hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy- O HO HO

MM0132.13- O O
3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(methylamino)- 992-62-1 25mg N
H
OH O O
0025 O

-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione HO
O
(3''-N-Desmethylerythromycin A; N-Demethylerythromycin A)
Related compound N (USP): N-Demethylerythromycin A
Impurity D (EP): (1S,2R,3R,4S,5R,8R,9S,10S,11R,12R,14R)-
OH

9-[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo- O
O O
O O
MM0132.09- hexopyranosyl)oxy]-5-ethyl-3-hydroxy-2,4,8,10,12,14-
23893-13-2 25mg N OH O O
O
0025 hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-
HO
O
hexopyranosyl]oxy]-6,15,16-trioxatricyclo[10.2.1.11,4]
hexadecan-7-one (Anhydroerythromycin A)
Impurity E (EP): (2R,3R,4S,5R,8R,9S,10S,11R,12R)-9-[(2,6-
Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]- O OH
O HO

MM0132.10- 5-ethyl-3,4-dihydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6- O O
33396-29-1 25mg N OH O O
0025 trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl]oxy]- O

HO
6,15-dioxabicyclo[10.2.1]pentadec-1(14)-en-7-one O

(Erythromycin A enol ether)


Impurity H (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O

N [(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH

MM0132.18- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- +
O O
e 992-65-4 25mg
0025 [[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl] N
O
OH
O
O O

oxy]oxacyclotetradecane-2,10-dione N-Oxide (Erythromycin A


w
HO
O

3''-N-Oxide; Erythromycin A N-Oxide)


Impurity J (EP) as (1S)-Isomer: OH

(1S,2R,3R,6R,7S,8S,9R,10R,12R)-7-[(2,6-Dideoxy-3-C- O OH

methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]-3-[(1R,2R)- O
H

O
O HO
MM0132.25 1,2-dihydroxy-1-methylbutyl]-1-hydroxy-2,6,8,10,12- 105900-46-7 50mg N OH O
O
O

pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-
HO
hexopyranosyl]oxy]-4,13-dioxabicyclo[8.2.1]tridecan-5-one O

(Pseudoerythromycin A Hemiketal)

Escitalopram Oxalate
F
O OH

O OH

MM1162.00 Escitalopram Oxalate 219861-08-2 250mg N


O

F
Impurity A (EP): (1RS)-1-[3-(Dimethylamino)propyl]-1-(4-
MM0242.14- fluorophenyl)-1,3-dihydro-2-benzofuran-5-carboxamide
64372-56-1 25mg N
0025 ((1RS)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3- O
H2 N

O
dihydroisobenzofuran-5-carboxamide; Citalopram-Amide)
Impurity B (EP) as Oxalate: 1-[3-(Dimethylamino)propyl]-1-(4-
F

fluorophenyl)-3-hydroxy-1,3-dihydro-2-benzofuran-5-
MM0242.21- O OH

carbonitrile Oxalate (1-[3-(Dimethylamino)propyl]-1-(4- 1332724-03-4 25mg O


N O OH
0025 N
fluorophenyl)-3-hydroxy-1,3-dihydroisobenzofuran-5- OH

carbonitrile Oxalate; 3-Hydroxycitalopram Oxalate)


F
Impurity C (EP): (1RS)-1-[3-(Dimethylamino)propyl]-1-(4-
fluorophenyl)-3-oxo-1,3-dihydro-2-benzofuran-5-carbonitrile
MM0242.17 372941-54-3 100mg N
((3RS)-6-Cyano-3-[3-(dimethylamino)propyl]-3-(4- O

N O
fluorophenyl)isobenzofuran-1(3H)-one; 3-Oxocitalopram)
F
Impurity C (EP): (1RS)-1-[3-(Dimethylamino)propyl]-1-(4-
MM0242.17- fluorophenyl)-3-oxo-1,3-dihydro-2-benzofuran-5-carbonitrile
372941-54-3 25mg N
0025 ((3RS)-6-Cyano-3-[3-(dimethylamino)propyl]-3-(4- O

N O
fluorophenyl)isobenzofuran-1(3H)-one; 3-Oxocitalopram)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-225
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity C (EP) as Oxalate: (1RS)-1-[3-(Dimethylamino)


F
propyl]-1-(4-fluorophenyl)-3-oxo-1,3-dihydro-2-benzofuran-5-
MM0242.20- O OH

carbonitrile Oxalate ((3RS)-6-Cyano-3-[3-(dimethylamino) 1440961-11-4 25mg O


N O OH

0025 N O
propyl]-3-(4-fluorophenyl)isobenzofuran-1(3H)-one Oxalate;
3-Oxocitalopram Oxalate)
Impurity D (EP) as Hydrochloride: (1RS)-1-(4-Fluorophenyl)-
F

1-[3-(methylamino)propyl]-1,3-dihydro-2-benzofuran-5-
MM0242.09- HCl
carbonitrile Hydrochloride ((1RS)-1-(4-Fluorophenyl)-1-[3- 97743-99-2 25mg N
H
0025 O

(methylamino)propyl]-1,3-dihydro-2-benzofuran-5-carbonitrile N

Hydrochloride; Desmethylcitalopram Hydrochloride)


Impurity E (EP) as Hydrobromide: (4RS)-4-[4-Cyano-2- F

MM0242.26- (hydroxymethyl)phenyl]-4-(4-fluorophenyl)-4-hydroxy-N,N- HBr


103146-26-5 25mg N
OH
0025 dimethylbutan-1-aminium Hydrobromide (Citadiol N
OH

Hydrobromide)
Impurity E (EP) as S-Enantiomer Ditoluoyltartrate: (4S)-4-[4-
Cyano-2-(hydroxymethyl)phenyl]-4-(4-fluorophenyl)-4-
hydroxy-N,N-dimethylbutan-1-amine (2S,3S)-2,3-Bis[(4-
methylbenzoyl)oxy]butanedioate (2:1) ((S)-Citadiol Di-p- F

O OH
MM1162.04- O
O
O
N
toluoyl-D-tartrate Salt (2:1); 4-[(1S)-4-(Dimethylamino)-1-(4- 128173-53-5 25mg N
OH O
HO O

OH
0025 2

fluorophenyl)-1-hydroxybutyl]-3-(hydroxymethyl)benzonitrile
Hemi-(+)-di-p-toluoyltartrate)
Related compound A (USP): (S)-4-[4-dimethylamino-1-(4-
fluoropheny)-1-hydroxy-1-butyl]-3-hydroxymethylbenzonitrile
Impurity E (EP) as S-Enantiomer free base: (4S)-4-[4-Cyano- F

2-(hydroxymethyl)phenyl]-4-(4-fluorophenyl)-4-hydroxy-N,N-
MM1162.06-
dimethylbutan-1-amine Hydrobromide ((S)-Citadiol) 488787-59-3 25mg N
0025 OH
Related compound A (USP): (S)-4-[4-dimethylamino-1-(4- N
OH
fluoropheny)-1-hydroxy-1-butyl]-3-hydroxymethylbenzonitrile
OH
MM1162.11- Impurity F (EP): (1RS)-1-[3-(Dimethylamino)propyl]-1- N
O
2102609-59-4 25mg
0025 hydroxy-1,3-dihydro-2-benzofuran-5-carbonitrile N

Impurity G (EP) as Dihydrobromide: 4-(Dimethylamino)-1-


[(1RS)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3- F

MM0242.28- dihydro-2-benzofuran-5-yl]butan-1-one Dihydrobromide (4- N

N
n/a 25mg O
HBr
2

0025 (Dimethylamino)-1-[(1RS)-1-[3-(dimethylamino)propyl]-1-(4- O

fluorophenyl)-1,3-dihydroisobenzofuran-5-yl]butan-1-one
Dihydrobromide)
F

Impurity H (EP): 3-[(1RS)-5-Cyano-1-(4-fluorophenyl)-1,3-


MM0242.10 dihydro-2-benzofuran-1-yl]-N,N-dimethylpropan-1-amine N- 63284-72-0 100mg +
N
O O
Oxide (Citalopram N-Oxide) N

Impurity H (EP) as S-Enantiomer: 3-[(1S)-5-Cyano-1-(4-


MM1162.05 fluorophenyl)-1,3-dihydro-2-benzofuran-1-yl]-N,N- 917482-45-2 100mg N
+

O O
dimethylpropan-1-amine N-Oxide (Escitalopram N-Oxide) N

O O
Impurity J (EP) as Hydrate: 4-Methylbenzenesulfonic Acid S
OH H2O
MM0598.02 6192-52-5 100mg
Hydrate (p-Toluenesulfonic Acid Hydrate)
F
Impurity K (EP) as Oxalate: (1R)-1-[3-(Dimethylamino)
MM1162.03- O OH

propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5- 219861-53-7 25mg O


N O OH
0025
N
carbonitrile ((R)-Citalopram Oxalate)
F

MM0242.29-
1-(4-Fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile 64169-67-1 25mg
0025
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-226
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O O
HO OH
O O
MM1497.03- O O
(+)-Di-p-toluoyl-D-(+)-tartaric Acid 32634-68-7 25mg
0025

Esflurbiprofen
F OH

MM3707.00 Esflurbiprofen 51543-39-6 100mg O

Esketamine Hydrochloride
O
Cl
MM3764.00- NH
HCl
Esketamine Hydrochloride 33643-47-9 100mg
0100
O

MM0144.10- Impurity D (EP) as Hydrochloride: (2R)-2-(2-Chlorophenyl)-2- NH


Cl
HCl
(methylamino)cyclohexanone Hydrochloride ((R)-Ketamine 33795-24-3 25mg
0025 Hydrochloride)

Eslicarbazepine Acetate
O

N N H2
MM3544.00 Eslicarbazepine Acetate 236395-14-5 100mg O
O

Esomeprazole Magnesium Trihydrate


2+
Mg
O N

MM1036.00 Esomeprazole Magnesium Trihydrate 217087-09-7 250mg N S


O N
O
H2 O
3

Impurity A (EP): 5-Methoxy-1H-benzimidazole- O NH


MM0095.03 37052-78-1 100mg
2-thiol N SH

MM0095.03- Impurity A (EP): 5-Methoxy-1H-benzimidazole- O NH


37052-78-1 25mg
0025 2-thiol N SH

Impurity B (EP): 2-[(RS)-[(3,5-Dimethylpyridin- O NH

MM0095.04 2-yl)methyl]sulphinyl]-5-methoxy-1H-benz- 110374-16-8 100mg N S


O N
imidazole

MM0095.04- Impurity B (EP): 2-[(RS)-[(3,5-Dimethylpyridin- O NH

2-yl)methyl]sulphinyl]-5-methoxy-1H-benz- 110374-16-8 25mg N S


O N
0025 imidazole
Impurity C (EP): 5-Methoxy-2-[[(4-methoxy-3,5- O NH

MM0095.06 dimethylpyridin-2-yl)methyl]-sulphanyl]-1H- 73590-85-9 100mg N S


O

N
benzimidazole (Ufiprazole)

MM0095.06- Impurity C (EP): 5-Methoxy-2-[[(4-methoxy-3,5- O NH

dimethylpyridin-2-yl)methyl]-sulphanyl]-1H- 73590-85-9 25mg N S


O

N
0025 benzimidazole (Ufiprazole)
Impurity D (EP): 5-Methoxy-2-[[(4-methoxy-3,5- O NH

MM0095.05 dimethylpyridin-2-yl)methyl]sulphonyl]-1H- 88546-55-8 100mg N S


O O
O

N
benzimidazole (Omeprazole Sulphone)

MM0095.05- Impurity D (EP): 5-Methoxy-2-[[(4-methoxy-3,5- O NH

dimethylpyridin-2-yl)methyl]sulphonyl]-1H- 88546-55-8 25mg N S


O O
O

N
0025 benzimidazole (Omeprazole Sulphone)
Impurity E (EP): 4-Methoxy-2-[[(RS)-(5-methoxy- O NH

MM0095.07 1H-benzimidazol-2-yl)sulphinyl]methyl]-3,5- 176219-04-8 100mg N S


O N
+
O

dimethylpyridine 1-Oxide (Omeprazole N-Oxide) O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-227
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0095.10-
2,3,5-Trimethylpyridine N-Oxide 74409-42-0 25mg
0025 +
N
O

MM0095.51- HO
2-Hydroxymethyl-3,5-dimethylpyridine 202932-05-6 100mg
0100 N

Esomeprazole Sodium
O +
N Na

MM3373.00 Esomeprazole Sodium 161796-78-7 250mg N S


O

O N

O NH
MM0095.03 Impurity A (EP): 5-Methoxy-1H-benzimidazole-2-thiol 37052-78-1 100mg
N SH

MM0095.03- O NH
Impurity A (EP): 5-Methoxy-1H-benzimidazole-2-thiol 37052-78-1 25mg
0025 N SH

Impurity C (EP): 5-Methoxy-2-[[(4-methoxy-3,5- O NH


O
MM0095.06 dimethylpyridin-2-yl)methyl]sulfanyl]-1H-benzimidazole 73590-85-9 100mg N S
N

(Ufiprazole)
Impurity C (EP): 5-Methoxy-2-[[(4-methoxy-3,5- O NH
MM0095.06- O
dimethylpyridin-2-yl)methyl]sulfanyl]-1H-benzimidazole 73590-85-9 25mg N S

0025 N

(Ufiprazole)
Impurity D (EP): 5-Methoxy-2-[(4-methoxy-3,5- O NH
O
MM0095.05 dimethylpyridin-2-yl)methanesulfonyl]-1H-benzimidazole 88546-55-8 100mg N S
O O N

(Omeprazole Sulfone)
Impurity D (EP): 5-Methoxy-2-[(4-methoxy-3,5- O NH
MM0095.05- O
dimethylpyridin-2-yl)methanesulfonyl]-1H-benzimidazole 88546-55-8 25mg N S
O O N
0025
(Omeprazole Sulfone)
Impurity E (EP): 4-Methoxy-2-[[(RS)-5-methoxy-1H- O NH
O
MM0095.07 benzimidazole-2-sulfinyl]methyl]-3,5-dimethylpyridine 1-Oxide 176219-04-8 100mg N S
+
O N
O
(Omeprazole N-Oxide)
Impurity F (EP): 8-Methoxy-1,3-dimethyl-12-
S
O
sulfanylidenepyrido[1',2':3,4]imidazo[1,2-a]benzimidazol-2 N
MM0095.01 125656-82-8 50mg N
(12H)-one (8-Methoxy-1,3-dimethyl-12-thioxopyrido[1',2':3,4] O N

imidazo[1,2-a]benzimidazol-2(12H)-one)
Impurity G (EP): 9-Methoxy-1,3-dimethyl-12-
S
O
sulfanylidenepyrido[1',2':3,4]imidazo[1,2-a]benzimidazol-2 O N
MM0095.02 125656-83-9 50mg N
(12H)-one (9-Methoxy-1,3-dimethyl-12-thioxopyrido[1',2':3,4] N

imidazo[1,2-a]benzimidazol-2(12H)-one)

MM0095.10-
2,3,5-Trimethylpyridine N-Oxide 74409-42-0 25mg
0025 +
N
O

MM0095.51- HO
2-Hydroxymethyl-3,5-dimethylpyridine 202932-05-6 100mg
0100 N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-228
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Estazolam
N
N
N

MM1354.00 Estazolam 29975-16-4 CS 100mg Cl N

Estradiol Benzoate
OH

MM0301.00 Estradiol Benzoate 50-50-0 500mg O


H H
O

OH

MM0300.00- Impurity A (EP) as Hemihydrate: H


H2 O
35380-71-3 250mg
0250 Estradiol Hemihydrate HO
H H

Impurity C (EP): Estra-1,3,5(10)-triene-3,17 - H


MM0301.02 4147-13-1 100mg O

diyl Dibenzoate (Estradiol 3,17-Dibenzoate) O


H H

MM0301.02- Impurity C (EP): Estra-1,3,5(10)-triene-3,17 - H


4147-13-1 25mg O

0025 diyl Dibenzoate (Estradiol 3,17-Dibenzoate) O


H H

MM0301.07- Impurity D (EP): 3-Hydroxyestra-1,3,5(10)-trien- O

983-30-2 25mg H

0025 17 -yl Benzoate (Estradiol 17-Benzoate) H H


HO

OH

MM0301.03- Impurity E (EP): 17 -Hydroxyestra-1,3,5(10)- O


H
H

H
6045-53-0 25mg
0025 trien-3-yl Benzoate (17-epi-Estradiol Benzoate) O

Impurity G (EP): 17-Oxoestra-1,3,5(10)-trien-3-yl O


H

MM0301.08 2393-53-5 100mg H H

Benzoate (Estrone Benzoate) O

MM0301.08- Impurity G (EP): 17-Oxoestra-1,3,5(10)-trien-3-yl O


H

2393-53-5 25mg H H

0025 Benzoate (Estrone Benzoate) O

O
MM0278.01-
Benzoic Acid 65-85-0 250mg OH
0250

Estradiol Cypionate
O

MM3402.00 Estradiol Cypionate 313-06-4 250mg H

H H
HO

Estradiol Enanthate
O

O
MM0473.00-
Estradiol Enanthate 4956-37-0 250mg H

H H
0250 HO

H
MM0473.01 Estrone 3-Acetate 901-93-9 100mg O
H H
O

MM0473.01- H
Estrone 3-Acetate 901-93-9 25mg O
H H
0025 O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-229
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Estradiol Hemihydrate
OH

MM0300.00- H
Estradiol Hemihydrate 35380-71-3 250mg H H
H2 O

0250 HO
2

Impurity A (EP): 3-Hydroxyestra-1,3,5(10)- H


MM0282.00 53-16-7 500mg
trien-17-one (Estrone) H H
HO

OH

Impurity B (EP): Estra-1,3,5(10)-triene-3,17 - H


MM0300.01 57-91-0 100mg
diol (17 -Estradiol; 17-epi-Estradiol) H H
HO

OH

Impurity C (EP): 4-Methylestra-1,3,5(10)-triene- H

MM0300.06 6171-48-8 100mg


3,17 -diol (4-Methylestradiol) HO
H H

OH

MM0300.06- Impurity C (EP): 4-Methylestra-1,3,5(10)-triene- H

6171-48-8 25mg
0025 3,17 -diol (4-Methylestradiol) HO
H H

OH

Impurity D (EP): Estra-1,3,5(10),9(11)-tetraene- H


MM0300.02 791-69-5 100mg
3,17 -diol (9,11-Didehydroestradiol) H
HO

OH

MM0300.02- Impurity D (EP): Estra-1,3,5(10),9(11)-tetraene- H


791-69-5 25mg
0025 3,17 -diol (9,11-Didehydroestradiol) H
HO

OH

H
MM0300.03-
6 -Hydroxyestradiol 3583-03-7 25mg H H
0025 HO
OH

OH

MM0300.04 6 -Hydroxyestradiol 1229-24-9 100mg H H


HO
OH

OH

H
MM0300.04-
6 -Hydroxyestradiol 1229-24-9 25mg H H
0025 HO
OH

OH

6-Ketoestradiol H

MM0300.08 Related compound C (USP): 1,3,5(10)-estratrien-3,17beta- 571-92-6 100mg H H

diol-6-one HO
O

OH

MM0300.08- 6-Ketoestradiol H

Related compound C (USP): 1,3,5(10)-estratrien-3,17beta- 571-92-6 25mg H H


0025 diol-6-one HO
O

OH
Estra-1,3,5(10),6-tetraene-3,17ß-diol (6,7-Didehydroestradiol)
MM0300.09- H
Related compound B (USP): 1,3,5(10),6-estratetraen- 7291-41-0 25mg
0025 H H
3,17beta-diol HO

O
MM0300.11-
Estradiol 17-Acetate 1743-60-8 25mg H

0025 H H
HO

MM0300.12 Estradiol Diacetate 3434-88-6 100mg O


H

H H
O

O
MM0300.12-
Estradiol Diacetate 3434-88-6 25mg O
H

0025 H H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-230
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH

H
O
MM0300.18 2-Methoxyestradiol 362-07-2 100mg
H H
HO

OH

MM0300.18- O
H
2-Methoxyestradiol 362-07-2 25mg
0025 H H
HO

Estradiol Valerate
O

MM0209.00 Estradiol Valerate 979-32-8 500mg H

H H
HO

OH

MM0300.00- Impurity A (EP) as Hemihydrate: H


H2 O
35380-71-3 250mg
0250 Estradiol Hemihydrate HO
H H

Impurity B (EP): 17 -Hydroxyestra- OH

H
MM0209.06 1,3,5(10)-trien-3-yl Pentanoate 21881-45-8 100mg O
H H

(Estradiol 3-Valerate) O

MM0209.06- Impurity B (EP): 17 -Hydroxyestra- OH

H
1,3,5(10)-trien-3-yl Pentanoate 21881-45-8 25mg O
H H
0025 (Estradiol 3-Valerate) O

Impurity C (EP): 3-Hydroxyestra- O

MM0209.01 1,3,5(10),9(11)-tetraen-17 -yl 95959-20-9 100mg H

Pentanoate H
HO
(9,11-Didehydroestradiol Valerate)
Impurity C (EP): 3-Hydroxyestra- O

O
MM0209.01- 1,3,5(10),9(11)-tetraen-17 -yl 95959-20-9 25mg H

0025 Pentanoate H
HO
(9,11-Didehydroestradiol Valerate)
O

Impurity D (EP): 3-Hydroxy-4-methylestra- O

MM0209.07 1,3,5(10)-trien-17 -yl Pentanoate n/a 100mg H


H

(4-Methylestradiol Valerate) HO

Impurity D (EP): 3-Hydroxy-4-methylestra- O


MM0209.07-
1,3,5(10)-trien-17 -yl Pentanoate n/a 25mg H
H

(4-Methylestradiol Valerate)
0025 HO

Impurity E (EP): Estra-1,3,5(10)-trien- O


O

MM0209.02 3,17 -diyl Dipentanoate 63042-28-4 100mg O


H
H

(Estradiol 3,17-Divalerate) O

Impurity E (EP): Estra-1,3,5(10)-trien- O


O

MM0209.02-
3,17 -diyl Dipentanoate 63042-28-4 25mg O
H
H

(Estradiol 3,17-Divalerate)
0025 O

Impurity F (EP): 3-Hydroxyestra-1,3,5(10)- O

MM0209.04 trien-17 -yl Butanoate 18069-79-9 100mg H

(Estradiol Butyrate) HO
H H

Impurity F (EP): 3-Hydroxyestra-1,3,5(10)- O


MM0209.04-
trien-17 -yl Butanoate 18069-79-9 25mg H

(Estradiol Butyrate)
0025 H H
HO

17-epi-Estradiol Valerate O

MM0209.03 182624-54-0 100mg H

(17 -Estradiol Valerate) H H


HO

MM0209.03- 17-epi-Estradiol Valerate O

182624-54-0 25mg H

0025 (17 -Estradiol Valerate) H H


HO

Estramustine Sodium Phosphate


OH

MM0100.01 Estramustine 2998-57-4 100mg Cl


N
O

O
H H

Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-231
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH

H
MM0100.01-
Estramustine 2998-57-4 25mg Cl
N
O

O
H H

0025 Cl

17 -17' -Bis3-{bis(2-
chloroethyl)carbamoyl- +
Na O

O
P
O O

O
P
O Na

O
+

MM0100.02 oxy}estra-1,3,5(10)- n/a 50mg Cl

Cl
N
O

O
H
H

H H
H

H
O
O

N
Cl
Cl

trienyl Pyrophosphate
Disodium Salt

Estriol
OH

H OH
MM0130.00 Estriol 50-27-1 100mg H H
HO

Impurity A (EP): Estra-1,3,5(10),9(11)-tetraene- OH

3,16 ,17 -triol (9,11-Didehydroestriol) H OH


MM0130.06 246021-20-5 100mg
Related compound A (USP): Estra-1,3,5(10),9(11)-tetraene- HO
H

3,16alpha,17Beta-triol
Impurity A (EP): Estra-1,3,5(10),9(11)-tetraene- OH

MM0130.06- 3,16 ,17 -triol (9,11-Didehydroestriol) H OH


246021-20-5 25mg
0025 Related compound A (USP): Estra-1,3,5(10),9(11)-tetraene- HO
H

3,16alpha,17Beta-triol
O

Impurity B (EP): 3-Hydroxyestra-1,3,5(10)- H


MM0282.00 53-16-7 500mg
trien-17-one (Estrone) H H
HO

OH

Impurity C (EP): 3-Methoxyestra-1,3,5(10)- H OH


MM0130.01 1474-53-9 100mg
triene-16 ,17 -diol (Estriol 3-Methyl Ether) O
H H

OH

MM0130.01- Impurity C (EP): 3-Methoxyestra-1,3,5(10)- H OH


1474-53-9 25mg
0025 triene-16 ,17 -diol (Estriol 3-Methyl Ether) O
H H

OH

MM0300.00- Impurity D (EP) as Hemihydate: H


H2 O
35380-71-3 250mg
0250 Estradiol Hemihydate HO
H H

OH

Impurity E (EP): Estra-1,3,5(10)-triene- H OH


MM0130.05 1228-72-4 100mg
3,16 ,17 -triol (17-epi-Estriol) HO
H H

OH

MM0130.05- Impurity E (EP): Estra-1,3,5(10)-triene- H OH


1228-72-4 25mg
0025 3,16 ,17 -triol (17-epi-Estriol) HO
H H

OH

Impurity F (EP): Estra-1,3,5(10)-triene- H OH


MM0130.04 547-81-9 100mg
3,16 ,17 -triol (16-epi-Estriol) HO
H H

OH

MM0130.04- Impurity F (EP): Estra-1,3,5(10)-triene- H OH


547-81-9 25mg
0025 3,16 ,17 -triol (16-epi-Estriol) HO
H H

OH

Impurity G (EP): Estra-1,3,5(10)-triene- H OH


MM0130.03 793-89-5 100mg
3,16 ,17 -triol (16,17-epi-Estriol) HO
H H

OH

MM0130.03- Impurity G (EP): Estra-1,3,5(10)-triene- H OH


793-89-5 25mg
0025 3,16 ,17 -triol (16,17-epi-Estriol) HO
H H

MM0130.21- Impurity H (EP): 3,16 -Dihydroxyestra-1,3,5(10)-trien-17-one H OH


566-76-7 25mg H H
0025 (16 -Hydroxyestrone) HO

OH

Impurity J (EP): Estra-1,3,5(10)-triene-3,17 -diol (17-epi- H


MM0300.01 57-91-0 100mg
Estradiol; 17 -Estradiol) H H
HO

Impurity K (EP): 17-Oxoestra-1,3,5(10)-trien-3-yl Acetate H


MM0473.01 901-93-9 100mg O
H H
(Estrone Acetate; Estrone 3-Acetate) O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-232
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0473.01- Impurity K (EP): 17-Oxoestra-1,3,5(10)-trien-3-yl Acetate H


901-93-9 25mg O
H H
0025 (Estrone Acetate; Estrone 3-Acetate) O

OH

H OH
MM0130.02-
6 -Hydroxyestriol 7291-49-8 25mg H H
0025 HO
OH

O
MM0130.14-
Estriol 16,17-Diacetate 805-26-5 25mg H O
O
0025 H H
HO

O
MM0130.15-
Estriol Triacetate 2284-32-4 25mg O
H O
O
0025 H H
O

OH

MM0130.16- H OH
Estriol 3-Benzyl Ether 18650-87-8 25mg H H
0025 O

OH

H O
MM0130.17 16-Oxoestradiol 566-75-6 100mg H H
HO

OH

MM0130.17- H O
16-Oxoestradiol 566-75-6 25mg H H
0025 HO

OH

H OH

MM0130.18 6-Oxoestriol 7323-86-6 100mg H H


HO
O

OH

H OH
MM0130.18-
6-Oxoestriol 7323-86-6 25mg H H
0025 HO
O

Estrogens conjugated
O

Impurity I (EP): 3-Hydroxyestra-1,3,5(10)-trien- H


MM0282.00 53-16-7 500mg
17-one (Estrone) H H
HO

Impurity J (EP): 3-Hydroxyestra-1,3,5(10),7-tetraen-17-one


MM1240.00 474-86-2 100mg
(Equilin) H H
HO

Estrone
O

H
MM0282.00 Estrone 53-16-7 500mg
H H
HO

H
MM0282.01 Estrone 3-Methyl Ether 1624-62-0 100mg
H H
O

MM0282.01- H
Estrone 3-Methyl Ether 1624-62-0 25mg
0025 H H
O

H
MM0473.01 Estrone 3-Acetate 901-93-9 100mg O
H H
O

MM0473.01- H
Estrone 3-Acetate 901-93-9 25mg O
H H
0025
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-233
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Estropipate
O

MM3774.00- H
Estropipate 7280-37-7 250mg O O
S
H H
HN
NH

0250 HO O

Eszopiclone
O
Cl
N O

MM3545.00 Eszopiclone 138729-47-2 250mg N


N
N N

O
N

O OH
O
(2R,3R)-2,3-Bis(benzoyloxy)butanedioic Acid O
MM0448.04 2743-38-6 100mg O
O
(Dibenzoyltartric Acid) HO O

O OH
O
MM0448.04- (2R,3R)-2,3-Bis(benzoyloxy)butanedioic Acid O
2743-38-6 25mg O
O
0025 (Dibenzoyltartric Acid) HO O

Etacrynic Acid (Ethacrynic Acid)


O
O
OH
MM1207.00 Etacrynic Acid 58-54-8 250mg Cl
O Cl

O
O
MM1207.05- O
Etacrynic Acid Ethyl Ester 23870-41-9 25mg Cl
0025 O Cl

O
O
MM1207.06- O
Etacrynic Acid Isopropyl Ester n/a 25mg Cl
0025 O Cl

O
O
MM1207.07- Methyl 2-[2,3-Dichloro-4-[2-(methoxymethyl)butanoyl] O

n/a 25mg Cl
0025 phenoxy]acetate O O Cl

Etafedrine Hydrochloride
OH
N
MM0718.00 Etafedrine Hydrochloride 530-35-8 100mg HCl

OH
H
MM0718.01- N
HCl
2-(Ethylamino)-1-phenylpropan-1-ol Hydrochloride 63401-08-1 25mg
0025

Etamivan
O
O
MM1682.00 Etamivan 304-84-7 100mg N

HO

Etamsylate
HO
MM0632.01-
Impurity A (EP): Benzene-1,4-diol (Hydroquinone) 123-31-9 250mg
0250 OH

Ethacridine Lactate Monohydrate


H2 O
NH2 O

MM0798.00 Ethacridine Lactate Monohydrate 6402-23-9 250mg O

OH
OH

H 2N N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-234
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Ethacrynic Acid, see Etacrynic Acid

Ethambutol Hydrochloride
HO
H

MM3062.00 Ethambutol Hydrochloride 1070-11-7 250mg N


N
H
HCl
2
OH

Ethaverine Hydrochloride
O
N

MM1575.00 Ethaverine Hydrochloride 985-13-7 100mg HCl


O
O

Ethenzamide
O

MM3063.00 Ethenzamide 938-73-8 250mg NH2

Ethinylestradiol (Ethinyl Estradiol)


OH

MM0123.00- H
Ethinylestradiol 57-63-6 250mg H H
0250 HO

Impurity B (EP): 19-Nor-17 -pregna-


OH
1,3,5(10),9(11)-tetraen-20-yne-3,17-diol
H
MM0123.02 (9,11-Didehydroethinylestradiol) 1231-96-5 50mg H
Related compound B (USP): 19-Nor-17alpha-pregna-1,3,5 HO

(10),9(11)-tetraen-20-yne-3,17-diol monohydrate
O

Impurity C (EP): 3-Hydroxyestra-1,3,5(10)- H


MM0282.00 53-16-7 500mg
trien-17-one (Estrone) H H
HO

OH

MM0300.00- Impurity D (EP) as Hemihydrate: H


H2 O
35380-71-3 250mg
0250 Estradiol Hemihydrate HO
H H

OH

Impurity E (EP): 19-Nor-17 -pregna-1,3,5(10)- H

MM0123.07 trien-20-yne-3,6 ,17-triol (6 -Hydroxyethinyl- 27521-34-2 100mg H H

estradiol) HO
OH

OH

MM0123.07- Impurity E (EP): 19-Nor-17 -pregna-1,3,5(10)- H

trien-20-yne-3,6 ,17-triol (6 -Hydroxyethinyl- 27521-34-2 25mg H H


0025
estradiol) HO
OH

OH

Impurity F (EP): 19-Nor-17 -pregna-1,3,5(10)- H

MM0123.06 trien-20-yne-3,6 ,17-triol (6 -Hydroxyethinyl- 56324-28-8 25mg H H

estradiol) HO
OH

Impurity G (EP): 3,17-Dihydroxy-19-nor-17 - OH

pregna-1,3,5(10)-trien-20-yn-6-one (6-Oxo- H

MM0123.05 38002-18-5 100mg


ethinylestradiol, 6-Ketoethinylestradiol) HO
H H

Related compound A (USP): 6-Keto-ethinyl estradiol O

Impurity G (EP): 3,17-Dihydroxy-19-nor-17 - OH

MM0123.05- pregna-1,3,5(10)-trien-20-yn-6-one (6-Oxo- H

38002-18-5 25mg
0025 ethinylestradiol, 6-Ketoethinylestradiol) HO
H H

Related compound A (USP): 6-Keto-ethinyl estradiol O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-235
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
Impurity I (EP): 19-Nor-17 -pregna-1,3,5(10),6-
H
MM0123.08 tetraen-20-yne-3,17-diol (6,7-Didehydroethinyl- 67703-68-8 50mg H H
estradiol) HO

OH

Impurity L (EP): Estra-1,3,5(10)-triene-3,17 - H


MM0300.01 57-91-0 100mg
diol (17 -Estradiol; 17-epi-Estradiol) H H
HO

OH

H
MM0123.15 Estradiol 3-Methyl Ether 1035-77-4 100mg
H H
O

OH

MM0123.15- H
Estradiol 3-Methyl Ether 1035-77-4 25mg
0025 H H
O

OH

H
MM1698.00 Mestranol (Ethinylestradiol 3-Methyl Ether) 72-33-3 250mg H H
O

Ethionamide
S

MM0845.00 Ethionamide 536-33-4 250mg NH2


N

O
S
MM0845.01-
Ethionamide Sulphoxide 536-28-7 25mg NH2
0025 N

MM0845.03 Impurity B (EP): Pyridine-4-carbonitrile 100-48-1 100mg


N

N
MM0845.03-
Impurity B (EP): Pyridine-4-carbonitrile 100-48-1 25mg
0025 N

Ethisterone
OH

H
MM0967.00 Ethisterone 434-03-7 250mg
H H
O

Ethosuximide
H
N
O O
MM0750.00 Ethosuximide 77-67-8 500mg

OH O
Impurity A (EP): (2RS)-2-Ethyl-2-methylbutanedioic Acid O OH
MM0750.01
Related compound A (USP)
631-31-2 100mg

OH O
MM0750.01- Impurity A (EP): (2RS)-2-Ethyl-2-methylbutanedioic Acid O OH
Related compound A (USP)
631-31-2 25mg
0025

Ethyl Biscoumacetate
O O O O

MM1886.00 Ethyl Biscoumacetate 548-00-5 50mg OH


O O
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-236
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Ethyl Maltol

HO
MM3722.00 Ethyl Maltol 4940-11-8 250mg O

Ethyl Nicotinate
O

MM1756.00 Ethyl Nicotinate 614-18-6 250mg N O

Ethyl Parahydroxybenzoate
O
MM0498.00- O
Ethyl Parahydroxybenzoate 120-47-8 250mg
0250 HO

O
MM0498.05 Sodium Ethyl Parahydroxybenzoate 35285-68-8 500mg
+ O
Na

O
MM0045.01-
Impurity A (EP): 4-Hydroxybenzoic Acid 99-96-7 250mg OH
0250
HO

O
MM0431.00- Impurity B (EP): Methyl 4-Hydroxybenzoate (Methyl O
99-76-3 250mg
0250 Parahydroxybenzoate)
HO

O
MM0432.00- Impurity C (EP): Propyl 4-Hydroxybenzoate O
94-13-3 250mg
0250 (Propyl Parahydroxybenzoate) HO

O
Impurity D (EP): Butyl 4-Hydroxybenzoate O
MM0496.00 94-26-8 500mg
(Butyl Parahydroxybenzoate) HO

Ethylmorphine Hydrochloride
N

MM0799.07 Ethylmorphine 76-58-4 CS 100mg H

O O OH

Impurity B (EP) as Hydrochloride Trihydrate: Morphine H HCl H 2O


MM0037.00 6055-06-7 CS 250mg 3

Hydrochloride Trihydrate HO O OH

Impurity B (EP) as Hemisulphate Pentahemihydrate: H


O
HO S O H H2O
5
MM0280.00 6211-15-0 CS 250mg O

Morphine Hemisulphate Pentahemihydrate HO O OH


2

MM0004.00 Impurity C (EP) as Monohydrate: Codeine Monohydrate 6059-47-8 CS 100mg H H2O

O O OH

Impurity C (EP) as Phosphate Hemihydrate: Codeine H


HO
P
OH

OH
H2O
MM0442.00 41444-62-6 CS 100mg O

Phosphate Hemihydrate O O OH
2
2

Impurity D (EP): 7,8-Didehydro-4,5 -epoxy-3-ethoxy-17- H


MM0799.06 93290-69-8 100mg
methylmorphinan-6-one (Ethylmorphinone)
O O O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-237
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0799.06- Impurity D (EP): 7,8-Didehydro-4,5 -epoxy-3-ethoxy-17- H


93290-69-8 25mg
0025 methylmorphinan-6-one (Ethylmorphinone)
O O O

Ethynodiol Diacetate
O

MM1960.00 Ethynodiol Diacetate 297-76-7 250mg H H


O
H H
O

Etidronate Disodium
O
O OH
P
MM3079.00 Etidronate Disodium 7414-83-7 250mg HO P
OH Na
+

2
O
O

Etilefrine Hydrochloride
OH
H
MM0035.00- HO N
Etilefrine Hydrochloride 943-17-9 250mg HCl

0250

Impurity A (EP) as Hydrochloride: 2-(Ethylamino)-1-(3- O


H
MM0035.01- HO N HCl
hydroxyphenyl)ethanone Hydrochloride (Etilefrone 22510-04-9 25mg
0025
Hydrochloride)
Impurity B (EP) as R-Enantiomer Hydrochloride: (1R)- OH
H
MM0081.00- HO N
1-(3-Hydroxyphenyl)-2-(methylamino)ethanol 61-76-7 250mg HCl

Hydrochloride (Phenylephrine Hydrochloride)


0250

Impurity C (EP) as Hydrochloride: (1RS)-2-Amino-1-(3- OH


MM0973.00- HO NH2 HCl
hydroxyphenyl)ethanol Hydrochloride (Norfenefrine 4779-94-6 250mg
0250
Hydrochloride)
Impurity D (EP) as Hydrochloride: 2-(Benzylethyl-
O
MM0035.08 amino)-1-(3-hydroxyphenyl)ethanone Hydro- 55845-90-4 100mg HO N
HCl

chloride (Benzyletilefrone Hydrochloride)

MM0035.08- Impurity D (EP) as Hydrochloride: 2-(Benzylethyl-


O

amino)-1-(3-hydroxyphenyl)ethanone Hydro- 55845-90-4 25mg HO N


HCl

0025 chloride (Benzyletilefrone Hydrochloride)


O
Impurity E (EP): 1-(3-Hydroxyphenyl)ethanone HO
MM0035.05 121-71-1 100mg
(3-Hydroxyacetophenone)

O
MM0035.05- Impurity E (EP): 1-(3-Hydroxyphenyl)ethanone HO
121-71-1 25mg
0025 (3-Hydroxyacetophenone)

Impurity F (EP): N-Benzylethanamine


MM0035.06 14321-27-8 100mg
(Benzylethylamine)
HN

OH

MM0035.09- HCl
2-Ethyl-1,2,3,4-tetrahydro-4,8-isoquinolinediol Hydrochloride n/a 25mg N
0025 OH

OH
MM0035.10- HO
HCl
2-Ethyl-1,2,3,4-tetrahydro-4,6-isoquinolinediol Hydrochloride n/a 25mg N
0025
O

MM0035.50 3-Benzoyloxyacetophenone 139-28-6 100mg O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-238
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
MM0035.50-
3-Benzoyloxyacetophenone 139-28-6 25mg O

0025 O

Etizolam
N
N
N
S
MM1386.00-
Etizolam 40054-69-1 CS 250mg N
0250
Cl

Etodolac

H
N
MM0911.00 Etodolac 41340-25-4 250mg O
O
HO

Impurity A (EP): 2-[(1RS)-1-Ethyl-1,3,4,9-tetrahydro- H


OH
N
MM0911.01 pyrano[3,4-b]indol-1-yl]acetic Acid (8-Desethyl 41339-67-7 100mg O

Etodolac)

Impurity A (EP): 2-[(1RS)-1-Ethyl-1,3,4,9-tetrahydro- H


OH
MM0911.01- N
pyrano[3,4-b]indol-1-yl]acetic Acid (8-Desethyl 41339-67-7 25mg O
0025 Etodolac)
O

Impurity B (EP): 2-[(1RS)-1-Ethyl-8-methyl-1,3,4,9- H


OH
N
MM0911.02 tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid 41340-19-6 100mg O

(8-Methyl Etodolac)
O

Impurity B (EP): 2-[(1RS)-1-Ethyl-8-methyl-1,3,4,9- H


OH
MM0911.02- N
tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid 41340-19-6 25mg O
0025 (8-Methyl Etodolac)

Impurity C (EP): 2-[(1RS)-8-Ethyl-1-methyl-1,3,4,9- O


tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid H
OH
N
MM0911.03 (1-Methyl Etodolac) 109518-47-0 100mg O

Related compound A (USP): (+/-)-8-ethyl-1-methyl-1,3,4,9-


tetrahydropyrano [3,4-b]-indole-1-acetic acid
Impurity C (EP): 2-[(1RS)-8-Ethyl-1-methyl-1,3,4,9- O

MM0911.03- tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid H


OH
N
(1-Methyl Etodolac) 109518-47-0 25mg O

0025 Related compound A (USP): (+/-)-8-ethyl-1-methyl-1,3,4,9-


tetrahydropyrano [3,4-b]-indole-1-acetic acid
O
Impurity D (EP): 2-[(1RS)-1-Ethyl-8-(1-methylethyl)- H
N OH
MM0911.04 1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl]acetic 57917-63-2 50mg O

Acid (8-Isopropyl Etodolac)


O
Impurity F (EP): 2-[(1RS)-8-Ethyl-1-(1-methylethyl)- H
N OH
MM0911.06 1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl]acetic 849630-65-5 100mg O

Acid (1-Isopropyl Etodolac)


O
Impurity F (EP): 2-[(1RS)-8-Ethyl-1-(1-methylethyl)- H
MM0911.06- N OH
1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl]acetic 849630-65-5 25mg O

0025 Acid (1-Isopropyl Etodolac)

O
Impurity G (EP): 2-[(1RS)-8-Ethyl-1-propyl-1,3,4,9-
H
MM0911.07 tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid 57816-83-8 100mg N
O
OH

(1-Propyl Etodolac)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-239
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
Impurity G (EP): 2-[(1RS)-8-Ethyl-1-propyl-1,3,4,9-
MM0911.07- H
tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid 57816-83-8 25mg N
O
OH

0025 (1-Propyl Etodolac)


H
N
OH
MM0911.08 Impurity H (EP): 2-(7-Ethylindol-3-yl)ethanol 41340-36-7 100mg

H
N
MM0911.08- OH
Impurity H (EP): 2-(7-Ethylindol-3-yl)ethanol 41340-36-7 25mg
0025

Impurity J (EP): (1RS)-1,8-Diethyl-1-methyl-1,3,4,9- H


N
MM0911.10 tetrahydropyrano[3,4-b]indole (Decarboxy 115066-03-0 100mg O

Etodolac)

Impurity J (EP): (1RS)-1,8-Diethyl-1-methyl-1,3,4,9- H


MM0911.10- N
tetrahydropyrano[3,4-b]indole (Decarboxy 115066-03-0 25mg O
0025 Etodolac)

O
Impurity K (EP): Methyl 2-[(1RS)-1,8-Diethyl-1,3,4,9- H
N O
MM0911.11 tetrahydropyrano[3,4-b]indol-1-yl]acetate 122188-02-7 100mg O

(Etodolac Methyl Ester)


O
Impurity K (EP): Methyl 2-[(1RS)-1,8-Diethyl-1,3,4,9- H
MM0911.11- N O
tetrahydropyrano[3,4-b]indol-1-yl]acetate 122188-02-7 25mg O

0025 (Etodolac Methyl Ester)


O

H
N O
O
MM0911.13 Etodolac Ethyl Ester 200880-23-5 100mg

H
MM0911.13- N O
O
Etodolac Ethyl Ester 200880-23-5 25mg
0025
O

H
MM0911.14- N O
O
Etodolac Isopropyl Ester n/a 25mg
0025

Etofenamate
O
O
O OH

NH
MM0105.00 Etofenamate 30544-47-9 250mg
F
F
F

OH

Impurity A (EP): 2-[[3-(Trifluoromethyl)phenyl]- NH


MM0410.00 530-78-9 500mg
amino]benzoic Acid (Flufenamic Acid)
F

F F

Impurity B (EP): Butyl 2-[[3-(Trifluoromethyl)phenyl]- NH


MM0105.02 67330-25-0 100mg
amino]benzoate (Butyl Flufenamate)
F
F
F

NH

MM0105.03 Impurity C (EP): N-Phenyl-3-(trifluoromethyl)aniline 101-23-5 100mg


F
F
F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-240
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O O
O
O O

Impurity D (EP): 2,2'-Oxybis(ethylene) Bis[2-[[3- NH HN


MM0105.04 64352-84-7 100mg
(trifluoromethyl)phenyl]amino]benzoate] F F
F F
F F

O
O
O O

Impurity E (EP): 2-(2-Butoxyethoxy)ethyl 2-[[3- NH


MM0105.05 n/a 100mg
(Trifluoromethyl)phenyl]amino]benzoate F
F
F

O
MM0105.06 Impurity F (EP): 2,2'-Oxydiethanol 111-46-6 100mg HO OH

O
OH
O

Impurity G (EP): 2-Hydroxyethyl 2-[[3-(Trifluoromethyl) NH


MM0105.07 32508-98-8 100mg
phenyl]amino]benzoate
F
F
F

O
OH
O

MM0105.07- Impurity G (EP): 2-Hydroxyethyl 2-[[3-(Trifluoromethyl) NH


32508-98-8 25mg
0025 phenyl]amino]benzoate
F
F
F

O O
O
O O

NH

MM0105.08 Etofenamate Myristate 81427-99-8 100mg F

F F

O O
O
O O

NH

MM0105.09 Etofenamate Palmitate 81427-95-4 100mg F

F F

O O
O
O O

NH

MM0105.10 Etofenamate Stearate 81427-97-6 100mg F

F F

O O
O
O O

NH
MM0105.10-
Etofenamate Stearate 81427-97-6 25mg F

0025 F F

O
O OH
O O

Triethylene Glycol Flufenamate


NH
MM0105.11 30544-48-0 100mg
F

F F

Etofylline
O

N OH
MM0603.00- N
Etofylline 519-37-9 250mg
0250 O N N

Etomidate
N

O
N
MM1264.00 Etomidate 33125-97-2 100mg O

OH
Impurity A (EP) as R-Enantiomer: 1-[(1R)-1-Phenylethyl]-1H- N
MM1264.04 56649-48-0 50mg
imidazole-5-carboxylic Acid (Etomidate Acid) O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-241
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Etoposide
O
O

O O
H O

MM0492.00 Etoposide 33419-42-0 250mg O

HO
OH
H

H
O

O
OH
O
O

Impurity D (EP): (5R,5aR,8aR,9S)-9-( -D- O


O
Glucopyranosyloxy)-5-(4-hydroxy-3,5-dimethoxyphenyl)- HO O
O
MM0492.04- HO H
5,8,8a,9-tetrahydro[2]benzofuro-[5,6-f][1,3]benzodioxol-6 23363-35-1 25mg O
OH
HO H
0025 O
O
OH
(5aH)-one (Lignan P; 4'-Demethylepipodophyllotoxin 9-( -D- O

Glucopyranoside))
OH
O O

Impurity E (EP): (5R,5aR,8aR,9S)-9-Hydroxy-5-(4-hydroxy-


MM0492.05- O
3,5-dimethoxyphenyl)-5,8,8a,9-tetrahydro[2]benzofuro[5,6-f] 6559-91-7 25mg H
O
0025 O
[1,3]benzodioxol-6(5aH)-one (4'-Demethylepipodophyllotoxin) O
H
OH

Etoposide Phosphate
O
O

H O O
O
MM3886.00-
Etoposide Phosphate (Etopophos) 117091-64-2 250mg O

HO
H
OH
H
O
O

O P OH
0250 O
O
O
OH

O
O

HO O
O
MM3886.01- HO H
O
Lignan P Phosphate n/a 25mg HO
OH
H
O
O P OH
0025 O
O
OH
O

Etoricoxib
O O
S

Cl
MM0965.00 Etoricoxib 202409-33-4 250mg
N

O O
S
4-Methylsulfonylacetophenone
MM0965.01 10297-73-1 100mg
Related compound A (USP): 4-methylsulfonyl acetophenone
O

O O
S
MM0965.01- 4-Methylsulfonylacetophenone
10297-73-1 25mg
0025 Related compound A (USP): 4-methylsulfonyl acetophenone
O

4-(Methylsulfonyl)phenylacetic Acid O O
S
O
MM0965.02 Related compound B (USP): 4-(methylsulfonyl)-phenyl acetic 90536-66-6 100mg
OH
acid
4-(Methylsulfonyl)phenylacetic Acid O O
MM0965.02- S
O
Related compound B (USP): 4-(methylsulfonyl)-phenyl acetic 90536-66-6 25mg
0025 OH
acid
Cl
2-Chloro-1,3-bis(dimethylamino)trimethinium +
N N
Hexafluorophosphate
MM0965.03 249561-98-6 100mg F F
Related compound C (USP): 2-chloro-1,3-bis
F P F
(dimethylamino)trimethinium hexafluorophosphate F F

Cl
2-Chloro-1,3-bis(dimethylamino)trimethinium +
N N
MM0965.03- Hexafluorophosphate
249561-98-6 25mg F F
0025 Related compound C (USP): 2-chloro-1,3-bis
F P F
(dimethylamino)trimethinium hexafluorophosphate F F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-242
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O O
S

MM0965.04- 5-Chloro-3-(4-methylsulfonylphenyl)-2-(pyridin-3-yl)pyridine Cl
202409-31-2 25mg
0025 (6 -Desmethyletoricoxib) N

O O
S

MM0965.05 1-(6-Methyl-3-pyridinyl)-2-[4-(methylsulfonyl)phenyl]ethanone 221615-75-4 100mg


O

O O
S

MM0965.05-
1-(6-Methyl-3-pyridinyl)-2-[4-(methylsulfonyl)phenyl]ethanone 221615-75-4 25mg
0025
O

S
MM0965.07- N
2-[4-(Methylsulfanyl)phenyl]acetonitrile 38746-92-8 25mg
0025

Etosalamide
O

MM1889.00 Etosalamide 15302-15-5 100mg NH2


O
O

Etretinate
O

MM3076.00 Etretinate 54350-48-0 100mg O


O

Eucalyptol, see Cineole

Eucalyptus Oil

O
MM1763.00 1,8-Cineole (Eucalyptol) 470-82-6 250mg

Eugenol
OH

MM3464.00 Eugenol 97-53-0 250mg


O

Impurity I (EP): 2-Methoxy-4-(prop-2-enyl)phenyl Acetate O


MM3464.01 93-28-7 100mg
(Acetyleugenol)
O

Exemestane
O

H
MM1161.00 Exemestane 107868-30-4 250mg H H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-243
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

H
MM1161.02- Impurity B (EP) as 6 -Isomer: 6 -Hydroxymethylandrosta-
121021-51-0 25mg H H
0025 1,4-diene-3,17-dione O

OH

O
Impurity D (EP): Androsta-1,4-diene-3,17-dione
H
MM0323.07 (Androstadienedione) 897-06-3 100mg
H H
Related compound C (USP): androsta-1,4-diene-3,17-dione O

O
Impurity D (EP): Androsta-1,4-diene-3,17-dione
MM0323.07- H
(Androstadienedione) 897-06-3 25mg
0025 H H
Related compound C (USP): androsta-1,4-diene-3,17-dione O

Impurity E (EP): 6-Methylideneandrost-4-ene-3,17-dione H


MM1161.01 Related compound A (USP): 6-Methyleneandrosta-4-ene- 19457-55-7 100mg H H
3,17-dione O

Impurity E (EP): 6-Methylideneandrost-4-ene-3,17-dione H


MM1161.01-
Related compound A (USP): 6-Methyleneandrosta-4-ene- 19457-55-7 25mg H H
0025 3,17-dione O

Ezetimibe
F

MM0935.00- F O
N
Ezetimibe 163222-33-1 250mg
0250 OH
OH

F
(3R,4S)-1-(4-Fluorophenyl)-3-[(3R)-3-(4-fluorophenyl)-3-
F O
N
MM0935.02 hydroxypropyl]-4-(4-hydroxyphenyl)-2-azetidinone ((3'R)- 163380-16-3 100mg
OH
OH
Ezetimibe)
F
(3R,4S)-1-(4-Fluorophenyl)-3-[(3R)-3-(4-fluorophenyl)-3-
MM0935.02- F O
N

hydroxypropyl]-4-(4-hydroxyphenyl)-2-azetidinone ((3'R)- 163380-16-3 25mg


0025 OH
OH
Ezetimibe)
F

F O
N

MM0935.03 Ezetimibe Ketone Benzyl Ether 190595-65-4 100mg O


O

F O
N
MM0935.03-
Ezetimibe Ketone Benzyl Ether 190595-65-4 25mg O
O
0025
O

HN O
MM0935.08-
(S)-(+)-4-Phenyloxazolidin-2-one 99395-88-7 25mg
0025

F
MM0935.10- O
4-Fluoronitrobenzene 350-46-9 50mg +
0050 N
O
F

F O
N
MM0935.11-
4'-O-Benzyloxy Ezetimibe 163222-32-0 25mg OH
O
0025
F

MM0935.12-
4-[[(4-Fluorophenyl)imino]methyl]phenol 3382-63-6 25mg N

0025 HO

N-Nitrosoezetimibe ((4S)-3-[(2R,5S)-2-[(S)-(4-Fluoro-N- F
O
N O
O
MM0935.13- N
O
N
nitrosoanilino)-(4-hydroxyphenyl)methyl]-5-(4-fluorophenyl)-5- n/a 25mg
0025 OH
F
hydroxy-pentanoyl]-4-phenyl-oxazolidin-2-one)
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-244
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Famciclovir
O
N
N
O

MM0620.00 Famciclovir 104227-87-4 250mg H 2N N N


O

Cl
O
N
9-[4-Acetoxy-3-(acetoxymethyl)butyl]-2-amino- N

N
O
H 2N N
6-chloropurine
MM0620.01 97845-60-8 100mg O

Cl
O
N
MM0620.01- 9-[4-Acetoxy-3-(acetoxymethyl)butyl]-2-amino- N

N
O
H 2N N
6-chloropurine
97845-60-8 25mg O
0025
O

2-[2-(2-Amino-9H-purin-9-yl)ethyl]propane-1,3-diol
N
N
Hydrochloride N
OH
HCl
MM0620.02 246021-75-0 100mg H 2N N
OH
Related compound A (USP): 2-[2-(2-Amino-9H-purin-9-yl)
ethyl]propane-1,3-diol
2-[2-(2-Amino-9H-purin-9-yl)ethyl]propane-1,3-diol
N
N
MM0620.02- Hydrochloride N
OH
HCl
246021-75-0 25mg H 2N N
OH
0025 Related compound A (USP): 2-[2-(2-Amino-9H-purin-9-yl)
ethyl]propane-1,3-diol
N
MM0620.19- N
2-Aminopurine
452-06-2 25mg N
0025 Related compound E (USP): 2-aminopurine H 2N N
H

Cl

MM0620.20- 2-Amino-6-chloropurine N
N
10310-21-1 25mg
0025 Related compound F (USP): 2-Amino-6-chloropurine N
H 2N N
H

Famotidine
N H2 N H 2O O

MM0029.00 Famotidine 76824-35-6 250mg H 2N


N
N

S
S N
S
NH2

Impurity A (EP) as Hydrochloride: 3-[[[2-


[(Diaminomethylene)amino]thiazol-4-yl]- H 2N
NH2

N
N
S
NH

NH2 HCl
MM0029.06 76833-47-1 100mg
methyl]sulfanyl]propanimidamide S

Hydrochloride
Impurity A (EP) as Hydrochloride: 3-[[[2-
MM0029.06- [(Diaminomethylene)amino]thiazol-4-yl]- H 2N
NH2

N
N
S
NH

NH2 HCl
76833-47-1 25mg
0025 methyl]sulfanyl]propanimidamide S

Hydrochloride
Impurity B (EP): 3,5-Bis[2-[[[2-[(diaminomethylidene)amino]
thiazol-4-yl]methyl]sulfanyl]ethyl]-4H-1,2,4,6-thiatriazine 1,1-
MM0029.13- Dioxide H2 N
NH2
N
S
O

N
S

N
O

S
N
H2 N
NH2

Related compound B (USP): 3,5-bis[2-[[[2-


89268-62-2 25mg N
S
H
S
N

0025
[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphany]
ethyl]-4H-1,2,4,6-thiatriazine1,1-dioxide
Impurity B (EP) as Dimaleate: 3,5-
Bis[2-[[[2-[(diaminomethylene)-
amino]-thiazol-4-yl]methyl]-
MM0029.05- sulfanyl]ethyl]-4H-1,2,4,6- H 2N
N H2

N
N
S
O

N
S

N
H
O

S
N
H 2N

N
NH2
O

OH
OH

thiatriazine 1,1-Dioxide Dimaleate


109467-08-5 25mg S S O
2

0025
Related compound B (USP): 3,5-bis[2-[[[2-
[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphany]
ethyl]-4H-1,2,4,6-thiatriazine1,1-dioxide
Impurity C (EP) as Hydrochloride: 3-[[[2-
[(Diaminomethylene)amino]thiazol-4-
yl]methyl]sulfanyl]-N-sulfamoyl- N H2 O O O

MM0029.01 propanamide Hydrochloride 76824-17-4 100mg H2 N


N
N

S
S N
H
S
N H 2 HCl

Related compound C (USP): 3-[[2-


(diaminomethyleneamino)thiazol-4-yl]methylthio]-N-
sulfamoylpropanamide

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-245
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity C (EP) as Hydrochloride: 3-[[[2-


[(Diaminomethylene)amino]thiazol-4-
MM0029.01- yl]methyl]sulfanyl]-N-sulfamoyl- N H2 O O O

propanamide Hydrochloride 76824-17-4 25mg H2 N


N
N

S
S N
H
S
N H 2 HCl

0025 Related compound C (USP): 3-[[2-


(diaminomethyleneamino)thiazol-4-yl]methylthio]-N-
sulfamoylpropanamide
Impurity D (EP): 3-[[[2-[(Diaminomethylene)-
amino]thiazol-4-yl]methyl]sulfanyl]- N H2 O

MM0029.02 propanamide 76824-16-3 100mg H2 N


N
N

S
S NH2

Related compound D (USP): 3-[[2-


(diaminomethyleneamino)thiazol-4-yl]methylthio]propanamide
Impurity D (EP): 3-[[[2-[(Diaminomethylene)-
MM0029.02- amino]thiazol-4-yl]methyl]sulfanyl]- N H2 O

propanamide 76824-16-3 25mg H2 N


N
N

S
S NH2

0025 Related compound D (USP): 3-[[2-


(diaminomethyleneamino)thiazol-4-yl]methylthio]propanamide
Impurity E (EP): 2,2'-[Disulfanediylbis-
(methylenethiazole-4,2-diyl)]diguanidine H 2N
NH2

N
N
S S
N
H2 N

N
N H2

Related compound E (USP): 2,2'-[4,4'-disulfanediylbis


MM0029.07 129083-44-9 100mg S S

(methylene)bis(thiazole-4,2-diyl)]diguanidine
Impurity E (EP): 2,2'-[Disulfanediylbis-
MM0029.07- (methylenethiazole-4,2-diyl)]diguanidine H 2N
NH2

N
N
S S
N
H2 N

N
N H2

Related compound E (USP): 2,2'-[4,4'-disulfanediylbis


129083-44-9 25mg S S

0025
(methylene)bis(thiazole-4,2-diyl)]diguanidine
Impurity F (EP): 3-[[[2-[(Diaminomethylene)-
amino]thiazol-4-yl]methyl]sulfanyl]- NH2 O

MM0029.03 propanoic Acid 107880-74-0 100mg H 2N


N
N

S
S OH

Related compound F (USP): 3-[[2-(diaminomethyleneamino)


thiazol-4-yl]methylthio]propanoic acid
Impurity F (EP): 3-[[[2-[(Diaminomethylene)-
MM0029.03- amino]thiazol-4-yl]methyl]sulfanyl]- NH2 O

propanoic Acid 107880-74-0 25mg H 2N


N
N

S
S OH

0025 Related compound F (USP): 3-[[2-(diaminomethyleneamino)


thiazol-4-yl]methylthio]propanoic acid
Impurity G (EP) as Maleate: N-Cyano-3-[[[2- NH2
NH
N
O

[(diaminomethylene)amino]thiazol-4-yl]methyl]sulfanyl]
OH
H2 N N
S N
N H OH
MM0029.09 n/a 100mg S
O

propanimidamide Maleate

MM0029.09- Impurity G (EP) as Maleate: N-Cyano-3-[[[2- NH2


NH
N
O

[(diaminomethylene)amino]thiazol-4-yl]methyl]sulfanyl]
OH
H2 N N
S N
N H OH
n/a 25mg S
O
0025 propanimidamide Maleate

MM0029.15- Impurity H (EP) as Dihydrochloride: [2- NH NH

[(Diaminomethylidene)amino]thiazol-4-yl]methyl 88046-01-9 25mg H 2N


N
H
N

S
S NH2
HCl
2

0025 Carbamimidothioate Dihydrochloride


MM0029.10- Impurity I (EP): 3-[[[2-[(Diaminomethylene)amino]thiazol-4-yl] H 2N
NH2
N
S
O

N
O
S
O

N H2
1020719-36-1 25mg N H

0025 methyl]sulfinyl]-N-sulfamoylpropanamide S
O

N H2 N H 2O O

MM0029.04 Famotidine Sulfoxide 90237-03-9 100mg H 2N


N
N

S
S
O
N
S
NH2

N H2 N H 2O O
MM0029.04-
Famotidine Sulfoxide 90237-03-9 25mg H 2N
N
N

S
S
O
N
S
NH2

0025

Famotidine Acetaldehyde Adduct Maleate (2-[4-[2-(3-Methyl- O


N H2 HN NH
OH
H 2N N S O
MM0029.16 n/a 100mg S N OH
1,1-dioxo-3,4-dihydro-2H-1,2,4,6-thiatriazin-5-yl) N
S
O

ethylsulfanylmethyl]-1,3-thiazol-2-yl]guanidine Maleate)
Famotidine Acetaldehyde Adduct Maleate (2-[4-[2-(3-Methyl- O
MM0029.16- H 2N
N H2
N
HN NH
S O
OH
S N OH
1,1-dioxo-3,4-dihydro-2H-1,2,4,6-thiatriazin-5-yl) n/a 25mg N
S
O

O
0025
ethylsulfanylmethyl]-1,3-thiazol-2-yl]guanidine Maleate)
Famotidine Formaldehyde Adduct Maleate (2-[4-[2-(1,1- O

NH2 HN NH
OH
H2 N N S O
S N OH
MM0029.17 Dioxo-3,4-dihydro-2H-1,2,4,6-thiatriazin-5-yl) n/a 100mg N O
S
O

ethylsulfanylmethyl]-1,3-thiazol-2-yl]guanidine Maleate)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-246
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Famotidine Formaldehyde Adduct Maleate (2-[4-[2-(1,1- O

MM0029.17- NH2 HN NH
OH
H2 N N S O
S N OH
Dioxo-3,4-dihydro-2H-1,2,4,6-thiatriazin-5-yl) n/a 25mg N O
S
O
0025
ethylsulfanylmethyl]-1,3-thiazol-2-yl]guanidine Maleate)

Famprofazone
O

MM0994.00 Famprofazone 22881-35-2 100mg N


N

MM0994.02- 5-[[Hydroxy(methyl)amino]methyl]-4-isopropyl-1-methyl-2- N
88913-10-4 25mg N
0025 phenylpyrazol-3-one
N
HO

Favipiravir
O
F N
MM3892.00- N H2
Favipiravir 259793-96-9 250mg
0250 N O
H

O
MM3892.05- F N
3,6-Difluoropyrazine-2-carboxamide 356783-29-4 25mg NH2
0025
N F

N
F N
MM3892.06-
3,6-Difluoropyrazine-2-carbonitrile 356783-28-3 25mg
0025
N F

Febantel
H
N S
O
O

MM1023.00 Febantel 58306-30-2 250mg O N

O N NH
H
O O

O
H
MM0518.00- Impurity C (EP): Methyl [5-(Phenylsulfanyl)-1H-benzimidazol- N O
43210-67-9 250mg N
H
S N
0250 2-yl]carbamate (Fenbendazole)

Febuxostat
N
O

MM3552.00 Febuxostat 144060-53-7 250mg


HO

O
S

N
OH
MM3552.01- 2-(3-Cyano-4-hydroxyphenyl)-4-methyl-5-thiazolecarboxylic HO
S
407582-48-3 25mg
0025 Acid (Desisobutylfebuxostat) O
N

N
MM3552.02- Febuxostat Ethyl Ester (2-[3-Cyano-4-(2-methylpropoxy) O
O
S
160844-75-7 25mg O
0025 phenyl]-4-methyl-5-thiazolecarboxylic Acid Ethyl Ester) N

Felbinac
OH

MM3501.00 Felbinac 5728-52-9 250mg O

MM3501.01 Impurity A (EP): 4-Acetyl Biphenyl 92-91-1 100mg

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-247
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM3501.01-
Impurity A (EP): 4-Acetyl Biphenyl 92-91-1 25mg
0025

O
MM3501.02 Felbinac Methyl Ester 59793-29-2 100mg

O
MM3501.03 Felbinac Ethyl Ester 14062-23-8 100mg

O
MM3501.04 Felbinac Isopropyl Ester 1286423-88-8 100mg
O

O OH

MM3501.05 Felbinac 1,3-Butylene Glycol Esters (Mixture of Isomers) n/a 100mg O OH

OH
O
MM3501.06-
Felbinac 2,3-Butylene Glycol Ester n/a 25mg O

0025
OH
O

MM3501.07-
Felbinac 1,2-Propylene Glycol Esters (Mixture of Isomers) n/a 25mg O
0025 OH
O

O O
MM3501.09- 3-[2-(4-Phenylphenyl)acetyl]oxybutyl 2-(4-Phenylphenyl) O O

n/a 25mg
0025 acetate
O

MM3501.10- [1-Methyl-2-[2-(4-phenylphenyl)acetyl]oxypropyl] 2-(4- O


O
n/a 25mg O
0025 Phenylphenyl)acetate

MM3501.11- 2-[2-(4-Phenylphenyl)acetyl]oxypropyl 2-(4-Phenylphenyl) O


O
n/a 25mg O
0025 acetate

Felodipine
H
N

O O
MM0139.00-
Felodipine 72509-76-3 250mg O O
0250 Cl

Cl

Impurity A (EP): Ethyl Methyl 4-(2,3- N

Dichlorophenyl)-2,6-dimethylpyridine-3,5- O O

MM0139.01 dicarboxylate 96382-71-7 50mg O O


Cl
Related compound A (USP): ethyl methyl 4-(2,3- Cl
dichlorophenyl)-2,6-dimethylpyridine-3,5-dicarboxylate
H
N

Impurity B (EP): Dimethyl 4-(2,3- O O

MM0139.02 Dichlorophenyl)-2,6-dimethyl-1,4- 91189-59-2 100mg O O


dihydropyridine-3,5-dicarboxylate Cl

Cl

H
N

MM0139.02- Impurity B (EP): Dimethyl 4-(2,3- O O

Dichlorophenyl)-2,6-dimethyl-1,4- 91189-59-2 25mg O O


0025 dihydropyridine-3,5-dicarboxylate Cl

Cl

H
N
Impurity C (EP): Diethyl 4-(2,3- O O

MM0139.03 Dichlorophenyl)-2,6-dimethyl-1,4- 79925-38-5 100mg O O


Cl
dihydropyridine-3,5-dicarboxylate Cl

H
N

MM0139.03- Impurity C (EP): Diethyl 4-(2,3- O O

Dichlorophenyl)-2,6-dimethyl-1,4- 79925-38-5 25mg O O


Cl
0025 dihydropyridine-3,5-dicarboxylate Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-248
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cl
MM0139.05 2,3-Dichlorobenzaldehyde 6334-18-5 100mg

Cl

MM0139.05- Cl
2,3-Dichlorobenzaldehyde 6334-18-5 25mg
0025
Cl

Fenbendazole
O
H
MM0518.00- N O
Fenbendazole 43210-67-9 250mg N
H
S N
0250
Impurity A (EP): Methyl (1H-Benzimidazol-2- O
H
yl)carbamate (Carbendazim) N O
N
Related compound A (USP): Methyl (1H-benzimidazole-2-
MM2500.00 10605-21-7 100mg
H
N
yl)carbamate
Impurity B (EP): Methyl (5-Chloro-1H-benzimidazol- O
2-yl)carbamate H
N O
N
Related compound B (USP): Methyl [5(6)-
MM0518.04 20367-38-8 100mg H
Cl N

chlorobenzimidazole-2-yl]carbamate
Impurity B (EP): Methyl (5-Chloro-1H-benzimidazol- O
MM0518.04- 2-yl)carbamate H
N O
N
Related compound B (USP): Methyl [5(6)-
20367-38-8 25mg H
0025 Cl N

chlorobenzimidazole-2-yl]carbamate
O
H
N O

MM0518.01 Fenbendazole Sulphoxide (Oxfendazole) 53716-50-0 100mg S N


N
H

O
H
N O

MM0518.02 Fenbendazole Sulphone 54029-20-8 100mg S N


N
H

O O

O
H
N O
MM0518.02-
Fenbendazole Sulphone 54029-20-8 25mg S N
N
H

0025 O O

Fenbufen
O
OH

MM0918.00 Fenbufen 36330-85-5 500mg O

MM0918.03 Impurity C (EP): Biphenyl 92-52-4 100mg

O
4-(4-Chlorophenyl)-4-oxobutanoic Acid OH
MM0918.05
(3-(4-Chlorobenzoyl)propionic Acid)
3984-34-7 100mg O
Cl

O
MM0918.05- 4-(4-Chlorophenyl)-4-oxobutanoic Acid OH
3984-34-7 25mg
0025 (3-(4-Chlorobenzoyl)propionic Acid) Cl
O

O
O
MM0918.06-
Fenbufen Methyl Ester 54011-27-7 25mg O

0025
O
O
MM0918.07-
Fenbufen Ethyl Ester 1230-54-2 25mg O

0025
O
O
MM0918.08-
Fenbufen Isopropyl Ester n/a 25mg O

0025

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-249
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Fencamfamine Hydrochloride
Camfetamine Hydrochloride
HCl
MM0995.01 (N-Methyl-3-phenylnorbornan-2-amine 39628-11-0 100mg
Hydrochloride) HN

Camfetamine Hydrochloride
MM0995.01- HCl
(N-Methyl-3-phenylnorbornan-2-amine 39628-11-0 25mg
0025 Hydrochloride) HN

Fenclofenac
OH

O
O

MM3075.00 Fenclofenac 34645-84-6 100mg Cl

Cl

O
O

MM3075.01 Fenclofenac Methyl Ester 81585-78-6 100mg Cl

Cl

O
O

MM3075.02 Cl
Fenclofenac Ethyl Ester 86308-84-1 100mg

Cl

O
O

MM3075.03 Cl
Fenclofenac Isopropyl Ester n/a 100mg

Cl

Fenfluramine Hydrochloride
H
N

MM0608.00 Fenfluramine Hydrochloride 404-82-0 500mg HCl


F
F
F

N H2

MM0608.01 Norfenfluramine Hydrochloride 673-18-7 100mg HCl


F
F
F

N H2

MM0608.01-
Norfenfluramine Hydrochloride 673-18-7 25mg HCl

0025 F
F
F

O
N
N

MM0608.02 N-Nitrosofenfluramine 19023-40-6 100mg


F
F
F

Fenofibrate
O
Cl O
O
MM0505.00 Fenofibrate 49562-28-9 500mg
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-250
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP): (4-Chlorophenyl)(4- Cl OH


MM0505.01- hydroxyphenyl)methanone
Related compound A (USP): (4-chlorophenyl)(4-
42019-78-3 25mg
0025 O

hydroxyphenyl)methanone
Impurity B (EP): 2-[4-(4-Chlorobenzoyl)phenoxy]- O

MM0505.02- 2-methylpropanoic Acid (Fenofibric Acid) Cl O


OH

Related compound B (USP): 2-(4-(4-chlorobenzoyl)


42017-89-0 25mg
0025 O

phenoxy)-2-methylpropanoic acid
O

Impurity C (EP): (3RS)-3-[4-(4-Chlorobenzoyl)- Cl O

MM0505.03 217636-47-0 100mg


phenoxy]butan-2-one O

MM0505.03- Impurity C (EP): (3RS)-3-[4-(4-Chlorobenzoyl)- Cl O

217636-47-0 25mg
0025 phenoxy]butan-2-one O

Impurity D (EP): Methyl 2-[4-(4-Chlorobenzoyl)- Cl O


O
MM0505.04 42019-07-8 100mg
phenoxy]-2-methylpropanoate O

MM0505.04- Impurity D (EP): Methyl 2-[4-(4-Chlorobenzoyl)- Cl O


O
42019-07-8 25mg
0025 phenoxy]-2-methylpropanoate O

Impurity E (EP): Ethyl 2-[4-(4-Chlorobenzoyl)- Cl O


O
MM0505.05 42019-08-9 100mg
phenoxy]-2-methylpropanoate O

MM0505.05- Impurity E (EP): Ethyl 2-[4-(4-Chlorobenzoyl)- Cl O


O
42019-08-9 25mg
0025 phenoxy]-2-methylpropanoate O

Cl O
Impurity F (EP): (4-Chlorophenyl)[4-(1-methyl-
MM0505.06 154356-96-4 100mg
ethoxy)phenyl]methanone O

Cl O
MM0505.06- Impurity F (EP): (4-Chlorophenyl)[4-(1-methyl-
154356-96-4 25mg
0025 ethoxy)phenyl]methanone O

Impurity G (EP): 1-Methylethyl 2-[[2-[4-(4-Chloro-


benzoyl)phenoxy]-2-methylpropanoyl]oxy]-2- O

MM0505.07- methylpropanoate Cl O
O
O
O

Related compound C (USP): 1-methylethyl 2-[[2-[4-(4-


217636-48-1 25mg
O
0025
chlorobenzoyl)phenoxy]-2-methylpropanoyl]oxy]-2-
methylpropanoate

Fenoldopam Mesilate
Cl
HO
NH
HO O O

MM3411.00 Fenoldopam Mesilate 67227-57-0 250mg S


OH

HO

N-Methyl-6-Chloro-2,3,4,5-tetrahydro-1-(4-hydroxyphenyl)- Cl
HO
1H-3-benzazepine-7,8-diol Hydrochloride (N- N
MM3411.01- HO
HCl
Methylfenoldopam Hydrochloride) n/a 25mg
0025
Related compound A (USP): N-Methyl-6-chloro-2,3,4,5-
HO
tetrahydro-1-(4-hydroxyphenyl)-1H-3-benzazepine-7,8-diol

Fenoprofen Calcium
O O H2O

MM0790.00 Fenoprofen Calcium Dihydrate 71720-56-4 500mg O Ca


2+
2

O O
MM0790.02 Fenoprofen Methyl Ester 66202-87-7 100mg O

O O
MM0790.03 Fenoprofen Ethyl Ester 32929-74-1 100mg O

O O
MM0790.04 Fenoprofen Isopropyl Ester 120824-55-7 100mg O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-251
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O O

O OH
MM0790.05- Fenoprofen 1,3-Butylene Glycol Esters (Mixture of Regio-
n/a 25mg
0025 and Stereoisomers) O O OH

OH
MM0790.06- O O
Fenoprofen 2,3-Butylene Glycol Ester 2731414-11-0 25mg O
0025
OH
O O

O
MM0790.07- Fenoprofen 1,2-Propylene Glycol Esters (Mixture of Regio-
n/a 25mg
0025 and Stereoisomers) O O
OH
O

OH
O O OH

O
MM0790.08- Fenoprofen 1,2,3-Propanetriol Esters (Mixture of Regio- and
n/a 25mg
0025 Stereoisomers) O O
OH
O
OH

Fenspiride Hydrochloride
O
HCl
O
MM3773.00- NH
Fenspiride Hydrochloride 5053-08-7 250mg N
0250

Fentanyl

O N

MM0528.00 Fentanyl 437-38-7 CS 100mg N

Impurity A (EP) as Hydrochloride: N-Phenyl-N- O


+
O N
[cis,trans-1-oxido-1-(2-phenylethyl)piperidin- N
MM0528.09 n/a 100mg
4-yl]propanamide Hydrochloride (Fentanyl HCl

N-Oxide Hydrochloride)
O NH

Impurity B (EP): N-Phenyl-N-(piperidin-4-yl)propanamide N


MM0528.08 1609-66-1 100mg
(Norfentanyl)

O NH

MM0528.08- Impurity B (EP): N-Phenyl-N-(piperidin-4-yl)propanamide N


1609-66-1 25mg
0025 (Norfentanyl)

Impurity C (EP): N-Phenyl-N-[1-(2-phenylethyl)-


O N
piperidin-4-yl]acetamide N
MM0528.03
Related compound G (USP): Acetyl fentanyl; N-(1-
3258-84-2 CS 100mg
Phenethylpiperidin-4-yl)-N-phenylacetamide
Impurity C (EP): N-Phenyl-N-[1-(2-phenylethyl)-
O N
MM0528.03- piperidin-4-yl]acetamide N
Related compound G (USP): Acetyl fentanyl; N-(1-
3258-84-2 CS 25mg
0025
Phenethylpiperidin-4-yl)-N-phenylacetamide

Impurity D (EP): N-Phenyl-1-(2-phenylethyl)piperidin-


N
4-amine HN
MM0528.04
Related compound E (USP): N-Phenyl-1-(2-phenylethyl)-4-
21409-26-7 100mg
piperidinamine

Impurity D (EP): N-Phenyl-1-(2-phenylethyl)piperidin-


N
MM0528.04- 4-amine HN
Related compound E (USP): N-Phenyl-1-(2-phenylethyl)-4-
21409-26-7 25mg
0025
piperidinamine

MM0528.05- O
Impurity E (EP): Benzaldehyde 100-52-7 500mg
0500

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-252
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

H2 N
Impurity F (EP) as Hydrochloride: Aniline Hydrochloride HCl
MM0093.17 142-04-1 100mg
(Phenylamine Hydrochloride)

NH
MM0528.07 Impurity G (EP): N-Phenylpropanamide 620-71-3 100mg

NH
MM0528.07-
Impurity G (EP): N-Phenylpropanamide 620-71-3 25mg
0025

N
Impurity J (EP): 1-Benzyl-N-phenylpiperidin-4-amine
MM0528.15- HN
Related compound D (USP): N-Phenyl-1-(phenylmethyl)-4- 1155-56-2 25mg
0025
piperidinamine

Impurity L (EP): (2-Bromoethyl)benzene


Related compound A (USP): (2-bromoethyl)benzene
MM0528.13 103-63-9 100mg
Br

MM0528.19- O N HCl
1-(2-Phenylethyl)piperidin-4-yl Propanoate Hydrochloride n/a 25mg
0025 O

O N
MM0528.20-
Butyrfentanyl (Butyrylfentanyl) N
1169-70-6 CS 25mg
0025

O
MM0528.22-
1-(2-Phenylethyl)pyridin-2(1H)-one 18065-78-6 25mg N
0025
O

N O
MM0528.26- HN
tert-Butyl 4-(Phenylamino)piperidine-1-carboxylate 125541-22-2 25mg
0025

Fentanyl Citrate
O
OH
O N O
MM1383.00-
Fentanyl Citrate 990-73-8 CS 250mg N
OH
OH

OH
0250 O

O N

MM0528.00 Fentanyl 437-38-7 CS 100mg N

O
Imp A (EP) as Hydrochloride: (1rs,4rs)-1-(2-Phenylethyl)-4- O N
+

MM0528.09 (N-phenylpropanamido)piperidine N-oxide Hydrochloride n/a 100mg N


HCl

(Fentanyl N-Oxide Hydrochloride)


O NH

Impurity B (EP): N-Phenyl-N-(piperidin-4-yl)propanamide N


MM0528.08 1609-66-1 100mg
(Norfentanyl)

Impurity C (EP): N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]


acetamide
O N

MM0528.03 3258-84-2 CS 100mg N

Related compound G (USP): Acetyl fentanyl; N-(1-


Phenethylpiperidin-4-yl)-N-phenylacetamide

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-253
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity D (EP): N-Phenyl-1-(2-phenylethyl)piperidin-4-amine N

MM0528.04 Related compound E (USP): N-Phenyl-1-(2-phenylethyl)-4- 21409-26-7 100mg HN

piperidinamine

MM0528.05- O
Impurity E (EP): Benzaldehyde 100-52-7 500mg
0500

N
Impurity G (EP): 1-Benzyl-N-phenylpiperidin-4-amine
MM0528.15- HN
Related compound D (USP): N-Phenyl-1-(phenylmethyl)-4- 1155-56-2 25mg
0025
piperidinamine

Impurity I (EP): (2-Bromoethyl)benzene


MM0528.13 103-63-9 100mg
Related compound A (USP): (2-bromoethyl)benzene Br

Fenticonazole Nitrate
Cl

Fenticonazole Nitrate
Cl
+
N
MM1216.00 73151-29-8 250mg O HO O

N
S
N

Cl

Impurity B (EP) as Nitrate: 1-[(2RS)-2-(2,4-Dichlorophenyl)-2-


MM1216.04- Cl O
N
+

[[4-(benzenesulfinyl)benzyl]oxy]ethyl]-1H-imidazole Nitrate 80639-95-8 25mg O HO O

N
0025 S
O N
(Fenticonazole Sulfoxide Nitrate)
Cl

Impurity C (EP) as Nitrate: 1-[(2RS)-2-(2,4-Dichlorophenyl)-2-


Cl O
+
N
MM1216.05 [[4-(benzenesulfonyl)benzyl]oxy]ethyl]-1H-imidazole Nitrate 80676-29-5 100mg O HO O

N
S
O O N
(Fenticonazole Sulfone Nitrate)
Cl

Impurity C (EP) as Nitrate: 1-[(2RS)-2-(2,4-Dichlorophenyl)-2-


MM1216.05- Cl O
N
+

[[4-(benzenesulfonyl)benzyl]oxy]ethyl]-1H-imidazole Nitrate 80676-29-5 25mg O HO O

N
0025 S
O O N
(Fenticonazole Sulfone Nitrate)
Cl
MM1216.01 1-(Chloromethyl)-4-(phenylsulfanyl)benzene 1208-87-3 100mg S

Feprazone
O

N
MM0691.00 Feprazone 30748-29-9 50mg N

Ferulic Acid
O
O
OH
MM3388.00 Ferulic Acid (trans-4-Hydroxy-3-methoxycinnamic Acid) 537-98-4 100mg
HO

Fesoterodine Fumarate
O
N

MM3553.00 Fesoterodine Fumarate 286930-03-8 100mg O


O

OH
HO
O
OH

Fexofenadine Hydrochloride
OH HCl

MM0507.00 Fexofenadine Hydrochloride 153439-40-8 250mg N


OH

OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-254
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP): 2-[4-[4-[4-(Hydroxydiphenyl-


methyl)piperidin-1-yl]butanoyl]phenyl]-2-
methylpropanoic Acid (Ketofexofenadine) OH

O
N

Related compound A (USP): 4-[1-oxy-4-[4-


MM0507.01 76811-98-8 100mg O

OH

(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-alpha,alpha-
dimethyl benzeneacetic acid
Impurity A (EP): 2-[4-[4-[4-(Hydroxydiphenyl-
methyl)piperidin-1-yl]butanoyl]phenyl]-2-
MM0507.01- methylpropanoic Acid (Ketofexofenadine) OH

O
N

Related compound A (USP): 4-[1-oxy-4-[4-


76811-98-8 25mg O

0025 OH

(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-alpha,alpha-
dimethyl benzeneacetic acid
Impurity B (EP) as Hydrochloride Monohydrate: 2-[3-[(1RS)-
1-Hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl] O

MM0507.09- phenyl]-2-methylpropanoic Acid Hydrochloride Monohydrate n/a 25mg


N
OH
OH

0025 Related compound B (USP): 3-[1-hydroxy-4-[4- OH


HCl H 2O

(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-alpha,alpha-dimethyl
benzeneacetic acid
Impurity C (EP): (1RS)-4-[4-(Hydroxydiphenyl-
OH

methyl)piperidin-1-yl]-1-[4-(1-methylethyl)- OH
N

phenyl]butan-1-ol
MM0507.03 185066-37-9 100mg
Related compound C (USP)
Impurity C (EP): (1RS)-4-[4-(Hydroxydiphenyl-
OH
MM0507.03- methyl)piperidin-1-yl]-1-[4-(1-methylethyl)- OH
N

phenyl]butan-1-ol
185066-37-9 25mg
0025
Related compound C (USP)
NH

MM0055.02 Impurity E (EP): Diphenyl(piperidin-4-yl)methanol 115-46-8 100mg OH

NH

MM0055.02-
Impurity E (EP): Diphenyl(piperidin-4-yl)methanol 115-46-8 25mg OH
0025

Impurity C (EP) as Hydrochloride: (1RS)-4-[4-


HCl
OH
MM0507.18- (Hydroxydiphenylmethyl)piperidin-1-yl]-1-[4-(1-methylethyl) OH

n/a 25mg N

0025 phenyl]butan-1-ol Hydrochloride


Related compound C (USP)
Impurity D (EP): Methyl 2-[4-[(1RS)-1-Hydroxy-4-[4- OH

(hydroxydiphenylmethyl)piperidin-1-yl]-butyl]phenyl]-2-
OH

MM0507.04 154825-96-4 100mg N


O

methylpropanoate (Fexofenadine Methyl Ester) O

MM0507.04- Impurity D (EP): Methyl 2-[4-[(1RS)-1-Hydroxy-4-[4- OH

(hydroxydiphenylmethyl)piperidin-1-yl]-butyl]phenyl]-2-
OH

154825-96-4 25mg N
O

0025 methylpropanoate (Fexofenadine Methyl Ester) O

OH
MM0507.19- +
OH
HCl
n/a 25mg N
Fexofenadine N-Oxide Hydrochloride O
O

0025 OH

Finasteride
O H
N

MM0415.00-
Finasteride 98319-26-7 250mg H

H H
0250 O N
H H

O H

Impurity A (EP): N-(1,1-Dimethylethyl)-3-oxo- N

H
MM0415.01 4-aza-5 -androstane-17 -carboxamide 98319-24-5 100mg H H

(Dihydrofinasteride) O N
H H

O H

Impurity A (EP): N-(1,1-Dimethylethyl)-3-oxo- N

MM0415.01- H
4-aza-5 -androstane-17 -carboxamide 98319-24-5 25mg H H

(Dihydrofinasteride)
0025 O N
H H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-255
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
O

Impurity B (EP): Methyl 3-Oxo-4-aza-5 -androst- H


MM0415.02 103335-41-7 100mg
1-ene-17 -carboxylate ( -1-Aza Ester) H H
O N
H H

O
O

MM0415.02- Impurity B (EP): Methyl 3-Oxo-4-aza-5 -androst- H


103335-41-7 25mg
0025 1-ene-17 -carboxylate ( -1-Aza Ester) H H
O N
H H

O
OH

MM0415.04- 3-Oxo-4-aza-5 -androstane-17 -carboxylic H


103335-55-3 25mg
0025 Acid H H
O N
H H

O
OH

H
MM0415.05 Finasteride Acid 104239-97-6 100mg
H H
O N
H H

O
OH

MM0415.05- H
Finasteride Acid 104239-97-6 25mg
0025 H H
O N
H H

O H
N

MM0415.07- N-Cyclohexyl-3-oxo-4-aza-5 -androst-1-ene-17 - H


133216-45-2 25mg H H
0025 carboxamide O N
H H

O H
N

MM0415.08- H
3-Oxo-N-phenyl-4-aza-5 -androst-1-ene-17 -carboxamide 158522-79-3 25mg H H
0025 O N
H H

O H
N

MM0415.12- H
N-(1,1-Dimethylethyl)-3-oxoandrost-4-ene-17 -carboxamide 131267-80-6 25mg
0025 H H
O

Fingolimod Hydrochloride
HO OH

MM3554.00 Fingolimod Hydrochloride 162359-56-0 250mg N H2 HCl

Impurity B (EP) as Hydrochloride: 2-Amino-2-[2-(4- OH


MM3554.04- OH

NH2 HCl
heptylphenyl)ethyl]propane-1,3-diol Hydrochloride 162361-44-6 25mg
0025
(Fingolimod Heptyl Analogue)

MM3554.01- O O
O
Diethyl 2-Acetamido-2-[2-(4-octylphenyl)ethyl]propanedioate 162358-08-9 25mg O
NH

0025 O

O O

O O
MM3554.03 Diethyl Acetamidomalonate 1068-90-2 100mg HN

O O

MM3554.03- O O
Diethyl Acetamidomalonate 1068-90-2 25mg HN
0025
O

OH
MM3554.05- OH OH
3-Amino-3-(hydroxymethyl)-1-(4-octylphenyl)butane-1,4-diol
NH2
162361-49-1 25mg
0025 (1-Hydroxyfingolimod)

HO OH
MM3554.06- N
N,N-Dimethylfingolimod 1404433-87-9 25mg
0025

MM3554.07- I

1-(2-Iodoethyl)-4-octylbenzene 162358-07-8 100mg


0100

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-256
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Flavoxate Hydrochloride
O

MM0156.00 Flavoxate Hydrochloride 3717-88-2 100mg O


HCl

N
O O

Impurity B (EP): Ethyl 3-Methyl-4-oxo-2-phenyl- O


4H-1-benzopyran-8-carboxylate (3-Methyl-
MM0156.02 flavone-8-carboxylic Acid Ethyl Ester) 35888-94-9 100mg O

Related compound C (USP): 3-Methylflavone-8-carboxylic O O

acid ethyl ester


Impurity B (EP): Ethyl 3-Methyl-4-oxo-2-phenyl- O

MM0156.02- 4H-1-benzopyran-8-carboxylate (3-Methyl-


flavone-8-carboxylic Acid Ethyl Ester) 35888-94-9 25mg O
0025 Related compound C (USP): 3-Methylflavone-8-carboxylic O O

acid ethyl ester


Impurity C (EP): 1-Methylethyl 3-Methyl-4-oxo- O

MM0156.05- 2-phenyl-4H-1-benzopyran-8-carboxylate
1286165-14-7 25mg
0025 (3-Methylflavone-8-carboxylic Acid Isopropyl O

Ester) O O

MM0156.07- HCl
Flavoxate N-Oxide Hydrochloride n/a 25mg O
+
N
0025 O O
O

Flecainide Acetate
F F O
O
F N O
H

MM0488.00 Flecainide Acetate 54143-56-5 250mg O


HN

F
OH

F F

Impurity A (EP) as Hydrochloride: (8aRS)-3-[2,5-Bis(2,2,2- F F N

trifluoroethoxy)phenyl]-1,5,6,7,8,8a-hexahydroimidazo[1,5-a] F
O N

MM0488.06 pyridine Hydrochloride n/a 100mg O


F
Related compound A (USP): 3-[2,5-bis(2,2,2-trifluoroethoxy) HCl
F F

phenyl]-1,5,6,7,8,8a-hexahydroimidazo-[1,5a]pyridine
Impurity A (EP) as Hydrochloride: (8aRS)-3-[2,5-Bis(2,2,2- F F N

MM0488.06- trifluoroethoxy)phenyl]-1,5,6,7,8,8a-hexahydroimidazo[1,5-a] F
O N

pyridine Hydrochloride n/a 25mg O


F
0025 Related compound A (USP): 3-[2,5-bis(2,2,2-trifluoroethoxy) HCl
F F

phenyl]-1,5,6,7,8,8a-hexahydroimidazo-[1,5a]pyridine
H2 N
MM0488.02 Impurity B (EP): (RS)-(Piperidin-2-yl)methanamine 22990-77-8 100mg HN

F F O
O
F OH
Impurity D (EP): 2,5-Bis(2,2,2-trifluoroethoxy)-
MM0488.04 35480-52-5 100mg O
benzoic Acid F

F F

F F O
O
F OH
MM0488.04- Impurity D (EP): 2,5-Bis(2,2,2-trifluoroethoxy)-
35480-52-5 25mg O
0025 benzoic Acid F

F F

O
HO
MM0217.10 2,5-Dihydroxybenzoic Acid 490-79-9 100mg OH

OH

O
MM0217.10- HO
2,5-Dihydroxybenzoic Acid 490-79-9 25mg OH
0025
OH

Fleroxacin
F

N F

MM3738.00 Fleroxacin 79660-72-3 100mg N N

O
F
O OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-257
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Flibanserin Hydrochloride
O H
N

N
N
N
MM3222.00 Flibanserin 167933-07-5 250mg
F
F
F

Fluanisone
O

MM1247.00 Fluanisone 1480-19-9 250mg N


N
O
F

MM1247.02-
1-(2-Methoxyphenyl)piperazine Dihydrochloride 38869-49-7 25mg N
HCl
2
0025 HN O

Flubendazole
O
H
F N O

MM0463.00 Flubendazole 31430-15-6 100mg N


N
H

Impurity A (EP): Methyl [5-[4-(Formylamino)benzoyl]-1H-


H H
O N O
N
N
H
MM0463.01 n/a 100mg N

benzimidazol-2-yl]carbamate O

Impurity A (EP): Methyl [5-[4-(Formylamino)benzoyl]-1H-


H H
O N O
MM0463.01- N
N
H
n/a 25mg N

0025 benzimidazol-2-yl]carbamate O

H
F
Impurity B (EP): (2-Amino-1H-benzimidazol- N
NH2
MM0463.02 82050-13-3 100mg N
5-yl)(4-fluorophenyl)methanone O

H
F
MM0463.02- Impurity B (EP): (2-Amino-1H-benzimidazol- N
NH2
82050-13-3 25mg N
0025 5-yl)(4-fluorophenyl)methanone O

H
F
Impurity B (EP) as Hydrochloride: (2-Amino-1H- N
NH2
MM0463.09 n/a 100mg N
benzimidazol-5-yl)(4-fluorophenyl)methanone Hydrochloride O HCl

H
F
MM0463.09- Impurity B (EP) as Hydrochloride: (2-Amino-1H- N
NH2
n/a 25mg N
0025 benzimidazol-5-yl)(4-fluorophenyl)methanone Hydrochloride O HCl

H
F
MM0463.03- Impurity C (EP): (4-Fluorophenyl)(2-hydroxy- N
OH
1097107-40-8 25mg N
0025 1H-benzimidazol-5-yl)methanone O

H
F N
Impurity D (EP): (1H-Benzimidazol-5-yl)(4-
MM0463.04 n/a 100mg N
fluorophenyl)methanone O

H
F N
MM0463.04- Impurity D (EP): (1H-Benzimidazol-5-yl)(4-
n/a 25mg N
0025 fluorophenyl)methanone O

O
H
MM0463.05- Impurity E (EP): Methyl [5-(2-Fluorobenzoyl)- N
N
O

66939-00-2 25mg H

0025 1H-benzimidazol-2-yl]carbamate F O
N

MM0463.06- Impurity F (EP): Methyl [5-(4-Fluorobenzoyl)- F N


N
H
O

132119-20-1 25mg N
0025 1-methyl-1H-benzimidazol-2-yl]carbamate O

Impurity G (EP): Methyl [5-[4-(1-Methylethoxy)- O


H
N
N
H
O

MM0463.07 n/a 100mg N

benzoyl]-1H-benzimidazol-2-yl]carbamate O

O
MM0463.07- Impurity G (EP): Methyl [5-[4-(1-Methylethoxy)- O
H
N
N
H
O

n/a 25mg N

0025 benzoyl]-1H-benzimidazol-2-yl]carbamate O

Flucloxacillin Sodium
Cl O +
O Na
O

MM0489.00 Flucloxacillin Sodium Hydrate 34214-51-2 500mg O


N
H
N
F N

S
H2 O

H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-258
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP) as Disodium Salt: (4S)-2-


[Carboxy[[[3-(2-chloro-6-fluorophenyl)- Cl
O
O Na
+

5-methylisoxazol-4-yl]carbonyl]amino]methyl]- N F
H
HN
MM0489.01 68728-50-7 100mg
5,5-dimethylthiazolidine-4-carboxylic Acid O

O
N S

Disodium Salt (Penicilloic Acids of O O Na

Flucloxacillin Disodium Salt)


Impurity A (EP) as Disodium Salt: (4S)-2-
[Carboxy[[[3-(2-chloro-6-fluorophenyl)- Cl
O
O Na
+

MM0489.01- 5-methylisoxazol-4-yl]carbonyl]amino]methyl]- N F
H
HN
68728-50-7 25mg
0025 5,5-dimethylthiazolidine-4-carboxylic Acid O

O
N S

Disodium Salt (Penicilloic Acids of O O Na

Flucloxacillin Disodium Salt)


Impurity B (EP): (2RS,4S)-2-[[[[3-(2-Chloro-6-
O
fluorophenyl)-5-methylisoxazol-4-yl]- Cl OH

MM0489.02 carbonyl]amino]methyl]-5,5-dimethyl- 1276016-89-7 50mg O


N F
H
N
HN

S
thiazolidine-4-carboxylic Acid O

(Penilloic Acids of Flucloxacillin)


O
Impurity C (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
MM0026.04 551-16-6 100mg
heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H

O
Impurity C (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
MM0026.04- dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
551-16-6 25mg
0025 heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H

Cl

Impurity D (EP): 3-(2-Chloro-6-fluorophenyl)- N F


MM0489.03 3919-74-2 100mg
5-methylisoxazole-4-carboxylic Acid O OH

Cl

MM0489.03- Impurity D (EP): 3-(2-Chloro-6-fluorophenyl)- N F


3919-74-2 25mg
0025 5-methylisoxazole-4-carboxylic Acid O OH

Fluconazole
F

F
N
MM0235.00- HO
Fluconazole 86386-73-4 250mg N
N
0250
N
N
N

F
Impurity A (EP): (2RS)-2-(2,4-Difluorophenyl)- N
HO
MM0235.11 1-(1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol- 89429-59-4 100mg N
N

4-yl)propan-2-ol N

N N

F
MM0235.11- Impurity A (EP): (2RS)-2-(2,4-Difluorophenyl)- N
HO
1-(1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol- 89429-59-4 25mg N
N
0025 4-yl)propan-2-ol N

N N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-259
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N N
Impurity B (EP): 2-[2-Fluoro-4-(1H-1,2,4-triazol-1- N

MM0235.12- yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)propan- F
N
2-ol 871550-15-1 25mg HO
N
0025 Related compound A (USP): 2-[2-fluoro-4-(1H-1,2,4-triazol- N
N
1-yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)-propan-2-ol N
N

Impurity C (EP): 1,1'-(1,3-Phenylene)di-1H-1,2,4- N N


MM0235.13- triazole N

Related compound C (USP): 1,1'-(1,3-phenylene)di(1H-


514222-44-7 25mg N
0025 N
1,2,4-triazole) N

Impurity D (EP): 2-(4-Fluorophenyl)-1,3-bis(1H-


N
HO
MM0235.14- 1,2,4-triazol-1-yl)propan-2-ol
N
Related compound B (USP): 2-(4-fluorophenyl)-1,3-bis(1H-
81886-51-3 25mg N
0025
1,2,4-triazol-1-yl)-propan-2-ol N
N
N

F
MM1094.04- Impurity E (EP): 1-(2,4-Difluorophenyl)-2-(1H-1,2,4-triazol-1- N
86404-63-9 25mg N
0025 yl)ethanone F O N

F
MM0235.02- Impurity F (EP): (2RS)-2-(2,4-Difluorophenyl)-3- N
HO
118689-07-9 25mg
0025 (1H-1,2,4-triazol-1-yl)propane-1,2-diol N
N
OH

Impurity G (EP) as Mesilate: 1-[[(2RS)-2-(2,4-Difluorophenyl) F


O
N
O O
S
MM0235.08 86386-77-8 100mg N HO
oxiran-2-yl]methyl]-1H-1,2,4-triazole Mesilate F
N

MM0235.08- Impurity G (EP) as Mesilate: 1-[[(2RS)-2-(2,4-Difluorophenyl) F


O
N
O O
S
86386-77-8 25mg N HO

0025 oxiran-2-yl]methyl]-1H-1,2,4-triazole Mesilate F


N

F
Impurity H (EP): (2RS)-1-Bromo-2-(2,4-difluorophenyl)- N
HO
MM0235.07 150194-52-8 50mg
3-(1H-1,2,4-triazol-1-yl)propan-2-ol N
N
Br

F
MM0235.07- Impurity H (EP): (2RS)-1-Bromo-2-(2,4-difluorophenyl)- N
HO
150194-52-8 25mg
0025 3-(1H-1,2,4-triazol-1-yl)propan-2-ol N
N
Br

F
MM0235.01 2-(2,4-Difluorophenyl)propane-1,2,3-triol 173837-65-5 100mg HO
HO

OH

F
MM0235.01-
2-(2,4-Difluorophenyl)propane-1,2,3-triol 173837-65-5 25mg HO
0025 HO

OH

N
MM0235.03 1H-1,2,4-Triazole 288-88-0 100mg HN
N

N
MM0235.03-
1H-1,2,4-Triazole 288-88-0 25mg HN
0025 N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-260
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

F
MM0235.04 2-Chloro-2',4'-difluoroacetophenone 51336-94-8 100mg
O
Cl

MM0235.04- F
2-Chloro-2',4'-difluoroacetophenone 51336-94-8 25mg
0025
O
Cl

F
1-(2,4-Difluorophenyl)-2-(1H-1,2,4-triazol-1-
MM0235.06 206050-23-9 100mg
yl)ethanol HO N
N
N

F
MM0235.06- 1-(2,4-Difluorophenyl)-2-(1H-1,2,4-triazol-1-
206050-23-9 25mg
0025 yl)ethanol HO N
N
N

N
N
MM0235.09 4-Amino-1,2,4-triazole 584-13-4 100mg N
H 2N

N
MM0235.09- N
4-Amino-1,2,4-triazole 584-13-4 25mg N
0025
H 2N

N
F
N N OH
MM0235.17- 2-(2-Dimethylamino-4-fluorophenyl)-1,3-bis(1H-1,2,4-triazol-
960243-81-6 25mg N
0025 1-yl)propan-2-ol N
N N

N N
N N

N
N
MM0235.18- 2-[2,4-Bis(1,2,4-triazol-1-yl)phenyl]-1,3-bis(1,2,4-triazol-1-yl) N
HO
871550-18-4 25mg
0025 propan-2-ol N
N
N
N
N

MM0235.19- 1-Amino-2-(2,4-difluorophenyl)-3-(1H-1,2,4-triazol-1-yl) HO
126916-76-5 25mg H 2N
0025 propan-2-ol
N
N
N

F F

2-(2,4-Difluorophenyl)-1-[[2-(2,4-difluorophenyl)-2-hydroxy-3- F F
MM0235.20- OH HO
H
(1,2,4-triazol-1-yl)propyl]amino]-3-(1,2,4-triazol-1-yl)propan-2- n/a 25mg N
0025 N N
ol N N
N N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-261
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Flucytosine
NH2
F
N
MM0355.00 Flucytosine 2022-85-7 250mg
O N
H

O
F
MM0593.00- Impurity A (EP): 5-Fluoropyrimidine- HN
51-21-8 250mg
0250 2,4(1H,3H)-dione (Fluorouracil)
O N
H

Fludarabine Phosphate
N H2

N
N

MM3428.00- F N N
Fludarabine Phosphate 75607-67-9 250mg OH
0250 O
HO O
P OH
HO
O

NH2

MM3428.04- Impurity D (EP): 2-Fluoro-7H-purin-6-amine (2- N N


700-49-2 25mg
0025 Fluoroadenine)
F N N
H

N H2

N
N

MM3428.05- Impurity E (EP): 9- -D-Arabinofuranosyl-2-fluoro-9H-purin-6- F N N


21679-14-1 25mg OH
0025 amine (Fludarabine) O

OH
HO

Fludeoxyglucose

4,7,13,16,21,24-Hexaoxa-1,10-diazabicyclo[8.8.8] O O
O O
MM3981.03- hexacosane
23978-09-8 25mg N N
0025 Related compound A (USP): 4,7,13,16,21,24-hexaoxa-1,10-
diazabicyclo[8.8.8]hexacosane O O

O O

MM3981.07- O O
Tri-O-acetyl-D-glucal 2873-29-2 25mg O O
0025
O

Fludrocortisone Acetate
O
O
O
HO OH
MM0817.00 Fludrocortisone Acetate 514-36-3 250mg H

F H
O

Flufenamic Acid
O

OH

NH
MM0410.00 Flufenamic Acid 530-78-9 500mg
F

F F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-262
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

NH
MM0410.01 Flufenamic Acid Methyl Ester 2765-91-5 100mg
F

F F

NH
MM0410.02 Flufenamic Acid Ethyl Ester 2766-16-7 100mg
F

F F

NH
MM0410.03 Flufenamic Acid Isopropyl Ester 68749-59-7 100mg
F

F F

Fluindione
O

MM3728.00 Fluindione 957-56-2 250mg F

Flumazenil
N O

MM0762.00- N O
Flumazenil 78755-81-4 250mg
0250 F N

Impurity A (EP): 8-Fluoro-5-methyl-6-oxo-5,6-dihydro-4H- N O

imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic Acid N OH
MM0762.01 Related compound A (USP): 8-fluoro-5,6-dihydro-5-methyl- 84378-44-9 100mg
N
6-oxo-4H-imidazol-[1,5-alpha][1,4]benzodiazepine-3- F
O
carboxylic acid
Impurity A (EP): 8-Fluoro-5-methyl-6-oxo-5,6-dihydro-4H- N O

MM0762.01- imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic Acid N OH


Related compound A (USP): 8-fluoro-5,6-dihydro-5-methyl- 84378-44-9 25mg
N
6-oxo-4H-imidazol-[1,5-alpha][1,4]benzodiazepine-3-
0025 F
O
carboxylic acid
Impurity B (EP): Ethyl 8-Hydroxy-5-methyl-6-oxo-5,6-dihydro-
N O
4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylate
MM0762.02- N O

Related compound B (USP): Ethyl 8-hydroxy-5,6-dihydro-5- 131666-45-0 25mg


0025 HO N

methyl-6-oxo-4H-imidazol-[1,5-alpha][1,4]benzodiazepine-3- O

carboxylate
H O
N
Impurity D (EP): 7-Fluoro-4-methyl-3,4-dihydro-1H-1,4-
MM0762.04 78755-80-3 100mg
benzodiazepine-2,5-dione F N

H O
N
MM0762.04- Impurity D (EP): 7-Fluoro-4-methyl-3,4-dihydro-1H-1,4-
78755-80-3 25mg
0025 benzodiazepine-2,5-dione F N

H 2N O

H
MM0762.09- 2-(7-Fluoro-4-methyl-5-oxo-2,3,4,5,-tetrahydro-1H-1,4- N O HCl

n/a 25mg F N
0025 benzodiazepine-2-ylidene )glycine Ethyl Ester Hydrochloride O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-263
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Flumequine

N
MM0842.00 Flumequine 42835-25-6 250mg OH
F
O O

Impurity B (EP): Ethyl (RS)-9-Fluoro-5-methyl-1-oxo-6,7- N

MM0842.02 dihydro-1H,5H-benzo[i,j]quinolizine-2-carboxylate 42835-47-2 100mg O


F
(Flumequine Ethyl Ester) O O

MM0842.02- Impurity B (EP): Ethyl (RS)-9-Fluoro-5-methyl-1-oxo-6,7- N

dihydro-1H,5H-benzo[i,j]quinolizine-2-carboxylate 42835-47-2 25mg O


F
0025 (Flumequine Ethyl Ester) O O

Flumetasone Pivalate
O

Impurity A (EP): 6 ,9-Difluoro-11 ,17,21- HO OH


OH

H
MM0427.01 trihydroxy-16 -methylpregna-1,4-diene- 2135-17-3 100mg F H

3,20-dione (Flumetasone) O
F

Flunarizine Dihydrochloride
F
N
N

MM0175.00 Flunarizine Dihydrochloride 30484-77-6 500mg HCl


2

F
NH
N
Impurity A (EP): 1-[Bis(4-fluorophenyl)methyl]-
MM0175.04 27469-60-9 100mg
piperazine
F

F
NH
N
MM0175.04- Impurity A (EP): 1-[Bis(4-fluorophenyl)methyl]-
27469-60-9 25mg
0025 piperazine
F

Impurity C (EP) as Dihydrochloride: 1-[(RS)-(2- F


N

Fluorophenyl)(4-fluorophenyl)methyl]-4-[(2E)- N

MM0175.03 n/a 100mg F

3-phenylprop-2-enyl]piperazine HCl
2

Dihydrochloride
Impurity C (EP) as Dihydrochloride: 1-[(RS)-(2- F
N

MM0175.03- Fluorophenyl)(4-fluorophenyl)methyl]-4-[(2E)- N

n/a 25mg F

0025 3-phenylprop-2-enyl]piperazine HCl


2

Dihydrochloride
Cl

MM0175.02 Chlorobis-(4-fluorophenyl)methane 27064-94-4 100mg


F F

O
F +
N
N

MM0175.06 Flunarizine N-Oxide Dihydrochloride n/a 100mg HCl


2

Flunisolide Hemihydrate
OH
O

HO O

MM0379.00 Flunisolide Hemihydrate 77326-96-6 250mg H


H

H
O
H2 O

O
F
2

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-264
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Flunitrazepam
O
N

MM0069.00- O +
Flunitrazepam 1622-62-4 CS 250mg N N

0250 O
F

H O
N

MM0069.08- Impurity A (EP): 7-Amino-5-(2-fluorophenyl)-


H 2N N
1,3-dihydro-2H-1,4-benzodiazepin-2-one 894-76-8 25mg
0025 (7-Aminodemethylflunitrazepam) F

H O
N

Impurity B (EP): 5-(2-Fluorophenyl)-7-nitro-1,3- O +


N N
MM0069.02 dihydro-2H-1,4-benzodiazepin-2-one 2558-30-7 100mg
O
(Demethylflunitrazepam) F

H O
N

MM0069.02- Impurity B (EP): 5-(2-Fluorophenyl)-7-nitro-1,3- O +


N N
dihydro-2H-1,4-benzodiazepin-2-one 2558-30-7 25mg
O
0025 (Demethylflunitrazepam) F

N O
Impurity C (EP): 3-Amino-4-(2-
O +
MM0069.05 fluorophenyl)-1-methyl-6-nitroquinolin-2 n/a 100mg N
O
NH2
F
(1H)-one

N O
Impurity C (EP): 3-Amino-4-(2-
MM0069.05- O +
fluorophenyl)-1-methyl-6-nitroquinolin-2 n/a 25mg N
O
NH2
F
0025 (1H)-one

NH

MM0069.01- Impurity D (EP): (2-Fluorophenyl)[2-(methylamino)-5- O + O


735-06-8 25mg N
0025 nitrophenyl]methanone O F

Flunixin Meglumine
F F

F H
N
OH

MM0915.00 Flunixin Meglumine 42461-84-7 100mg N NH


HO

OH
OH

OH HO

N Cl

Impurity A (EP): 2-Chloropyridine-3-carboxylic Acid OH


Related compound A (USP): 2-Chloronicotinic acid
MM0915.01 2942-59-8 100mg
O

N Cl

MM0915.01- Impurity A (EP): 2-Chloropyridine-3-carboxylic Acid OH


Related compound A (USP): 2-Chloronicotinic acid
2942-59-8 25mg
0025
O

F F

Impurity B (EP): 2-Methyl-3-(trifluoromethyl)aniline F


MM0915.02 Related compound B (USP): 2-Methyl-3-(trifluoromethyl) 54396-44-0 100mg
aniline
N H2

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-265
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

F F

Impurity B (EP): 2-Methyl-3-(trifluoromethyl)aniline F


MM0915.02-
Related compound B (USP): 2-Methyl-3-(trifluoromethyl) 54396-44-0 25mg
0025 aniline
N H2

N Cl
Impurity C (EP): Ethyl 2-Chloropyridine-3-carboxylate O
Related compound C (USP): Ethyl 2-chloronicotinate
MM0915.03 1452-94-4 100mg
O

F F

Impurity D (EP): Ethyl 2-[[2-Methyl-3-(trifluoromethyl)phenyl]


MM0915.04 54396-42-8 100mg N NH
amino]pyridine-3-carboxylate (Flunixin Ethyl Ester)
O

F F

MM0915.04- Impurity D (EP): Ethyl 2-[[2-Methyl-3-(trifluoromethyl)phenyl]


54396-42-8 25mg N NH
0025 amino]pyridine-3-carboxylate (Flunixin Ethyl Ester)
O

H
N
OH

MM3394.00 Meglumine 6284-40-8 250mg HO


OH
OH
HO

F F

MM0915.05-
Flunixin Methyl Ester 75369-63-0 25mg N NH
0025
O

F F

MM0915.06-
Flunixin Isopropyl Ester n/a 25mg N NH
0025
O

Fluocinolone Acetonide
OH
O

HO O
MM1524.00-
Fluocinolone Acetonide 67-73-2 250mg H O

F H
0250 O
F

O
O
Impurity M (EP): 6 ,9-Difluoro-11 -hydroxy-16 ,17-(1-
MM3001.00- HO O
methylethylidenedioxy)-3,20-dioxopregna-1,4-dien-21-yl 356-12-7 250mg H O

0250 F H
Acetate (Fluocinonide) O
F

Fluocinonide
O

O
O

MM3001.00- HO O
Fluocinonide 356-12-7 250mg H O

0250 F H
O
F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-266
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Fluorescein
O

O
MM1533.01 Diacetylfluorescein 596-09-8 100mg O O

O O O

Fluorescein Sodium
HO OH
MM0294.01-
Impurity A (EP): Resorcinol 108-46-3 250mg
0250

OH

Impurity B (EP): Benzene-1,2-dicarboxylic Acid (Phthalic O


MM1057.02 88-99-3 100mg
Acid) OH

OH
Impurity C (EP): 2-(2,4-Dihydroxybenzoyl)benzoic O
Acid
Related compound C (USP): 2-(2,4-Dihydroxybenzoyl)
MM0133.04 2513-33-9 100mg OH

benzoic acid
OH

OH
Impurity C (EP): 2-(2,4-Dihydroxybenzoyl)benzoic O
MM0133.04- Acid
Related compound C (USP): 2-(2,4-Dihydroxybenzoyl)
2513-33-9 25mg OH
0025
benzoic acid
OH

Fluorometholone
O

HO OH
H
MM0870.00 Fluorometholone 426-13-1 250mg F H
O

Fluorouracil
O
F
MM0593.00- HN
Fluorouracil 51-21-8 250mg
0250
O N
H

H
Impurity A (EP): Pyrimidine-2,4,6-(1H,3H,5H)- O N O
trione (Barbituric Acid)
MM0265.03
Related compound A (USP): Pyrimidine-2,4,6(1H,3H,5H)-
67-52-7 100mg NH

trione
O

H
Impurity A (EP): Pyrimidine-2,4,6-(1H,3H,5H)- O N O
MM0265.03- trione (Barbituric Acid)
Related compound A (USP): Pyrimidine-2,4,6(1H,3H,5H)-
67-52-7 25mg NH
0025
trione
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-267
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
Impurity B (EP): Dihydropyrimidine-2,4,5(3H)-
O
MM0593.01- trione (Isobarbituric Acid or 5-Hydroxyuracil) HN
Related compound B (USP): Dihydropyrimidine-2,4,5(3H)-
496-76-4 25mg
0025
trione O N
H

MM0593.03- Impurity C (EP): Pyrimidine-2,4(1H,3H)-dione HN


66-22-8 25mg
0025 (Uracil)
O N
H

O
O
Impurity D (EP): 5-Methoxypyrimidine-2,4(1H,3H)- HN
MM0593.04 6623-81-0 100mg
dione (5-Methoxyuracil)
O N
H

O
O
MM0593.04- Impurity D (EP): 5-Methoxypyrimidine-2,4(1H,3H)- HN
6623-81-0 25mg
0025 dione (5-Methoxyuracil)
O N
H

O
Impurity E (EP): 5-Chloropyrimidine-2,4(1H,3H)-
Cl
MM0593.05- dione (5-Chlorouracil) HN
Related compound E (USP): 5-Chloropyrimidine-2,4
1820-81-1 25mg
0025
(1H,3H)-dione O N
H

Impurity F (EP): 2-Ethoxy-5-fluoropyrimidin- O


F
MM0593.06- 4(1H)-one (2-Ethoxy-5-fluorouracil) N
Related compound F (USP): 2-Ethoxy-5-fluoropyrimidin-4
56177-80-1 25mg
0025 O N
(1H)-one H

Fluoxetine Hydrochloride
H
O N
MM0256.00-
Fluoxetine Hydrochloride 56296-78-7 250mg F HCl
0250 F F

OH
Impurity A (EP): (1RS)-3-(Methylamino)-1- N
MM0256.01 42142-52-9 100mg
phenylpropan-1-ol H

OH
MM0256.01- Impurity A (EP): (1RS)-3-(Methylamino)-1- N
42142-52-9 25mg
0025 phenylpropan-1-ol H

Impurity B (EP) as Hydrochloride: N-Methyl-3- H


N
phenylpropan-1-amine Hydrochloride HCl

(Methyl-3-phenylpropylamine Hydrochloride)
MM0256.02 30684-07-2 CS 100mg
Related compound B (USP): N-Methyl-3-phenylpropylamine
Impurity B (EP) as Hydrochloride: N-Methyl-3- H
N
MM0256.02- phenylpropan-1-amine Hydrochloride HCl

(Methyl-3-phenylpropylamine Hydrochloride)
30684-07-2 CS 25mg
0025
Related compound B (USP): N-Methyl-3-phenylpropylamine
Impurity C (EP) as Hydrochloride: (3RS)-N-
H
Methyl-3-phenyl-3-[3-(trifluoromethyl)- O N

HCl
MM0256.03 phenoxy]propan-1-amine Hydrochloride 79088-29-2 100mg
F
Related compound A (USP): N-methyl-3-phenyl-3-[(alpha, F
F

alpha, alpha-trifluoro-m-tolyl)oxy]propylamine
Impurity C (EP) as Hydrochloride: (3RS)-N-
H

MM0256.03- Methyl-3-phenyl-3-[3-(trifluoromethyl)- O N

HCl
phenoxy]propan-1-amine Hydrochloride 79088-29-2 25mg
F
0025 Related compound A (USP): N-methyl-3-phenyl-3-[(alpha, F
F

alpha, alpha-trifluoro-m-tolyl)oxy]propylamine
OH

MM0256.05 4-Hydroxybenzotrifluoride 402-45-9 100mg F

F F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-268
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
MM0256.05-
4-Hydroxybenzotrifluoride 402-45-9 25mg F
0025
F F

Cl

MM0256.06 4-Chlorobenzotrifluoride 98-56-6 100mg F

F F

OH

MM0256.10 3-Dimethylamino-1-phenylpropan-1-ol 5554-64-3 100mg N

OH
MM0256.10-
3-Dimethylamino-1-phenylpropan-1-ol 5554-64-3 25mg N
0025
O

O N

MM0256.16 N-Formylfluoxetine 199188-97-1 100mg F

F F

F HCl
(3RS)-N-Methyl-3-phenyl-3-[2-(trifluoromethyl)- F
F
H
phenoxy]propan-1-amine Hydrochloride O N
MM0256.17
(2-Trifluoromethylisomer of Fluoxetine Hydro-
n/a 100mg
chloride)
F HCl
(3RS)-N-Methyl-3-phenyl-3-[2-(trifluoromethyl)- F
F
H
MM0256.17- phenoxy]propan-1-amine Hydrochloride O N

(2-Trifluoromethylisomer of Fluoxetine Hydro-


n/a 25mg
0025
chloride)
O N H2
HO O

MM0256.18 Norfluoxetine Oxalate 107674-50-0 100mg F

F F HO O

O N H2
MM0256.18- HO O

Norfluoxetine Oxalate 107674-50-0 25mg F

F F HO O
0025
OH
HO OH

OH
O O
HO
MM0256.19- Lactose Fluoxetine Amadori Rearrangement Product OH
OH

n/a 25mg O
O
N
0025 Hydrochloride F
HCl

F F

O N
MM0256.21-
885101-12-2 25mg F HCl
N-Methylfluoxetine Hydrochloride
0025 F F

O N O
MM0256.22- N

N-Nitrosofluoxetine 150494-06-7 25mg F

0025 F F

Fluoxymesterone
OH
HO
MM0959.00- H
Fluoxymesterone 76-43-7 250mg
0250 F H
O

Flupentixol Decanoate

Impurity B (BP): 2-Trifluoromethyl- S


MM0182.08 1693-28-3 100mg
thioxanthone
F

F F

O
MM0182.08- Impurity B (BP): 2-Trifluoromethyl- S
1693-28-3 25mg
0025 thioxanthone
F

F F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-269
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
MM0182.05- N
1-(2-Hydroxyethyl)piperazine 103-76-4 100mg HN
0100
O
+
N CF3
MM0182.09 4-Fluoro-3-nitrobenzotrifluoride 367-86-2 100mg O

Flupentixol Dihydrochloride
OH
N
N

MM0223.06 Flupentixol Dihydrochloride 2413-38-9 100mg S

F
HCl
2

F F

Impurity E (EP) as Dihydrochloride: 2-[4-[3-[(EZ)-2- O


N
N O
MM0223.17- (Trifluoromethyl)-9H-thioxanthen-9-ylidene]propyl]piperazin- S
HCl
2969-13-3 25mg 2

F
0025 1-yl]ethyl Acetate Dihydrochloride (O-Acetylflupentixol F F

Dihydrochloride)

O
Impurity G (EP): 2-(Trifluoromethyl)-9H-
MM0182.08 thioxanthen-9-one (2-Trifluoromethyl- 1693-28-3 100mg S

thioxanthone) F

F F

O
MM0182.08- Impurity G (EP): 2-(Trifluoromethyl)-9H-
thioxanthen-9-one (2-Trifluoromethyl- 1693-28-3 25mg S
0025 thioxanthone) F

F F

OH
MM0182.05- N
1-(2-Hydroxyethyl)piperazine 103-76-4 100mg HN
0100
O
+ OH
N
N
MM0223.08-
Flupentixol N1-Oxide n/a 25mg S

0025 F

F F

(EZ)-3-[2-(Trifluoromethyl)-9H-thioxanthen-9-ylidene]propene
MM0223.15- S
Sulfoxide (9-Allylidene-2-(trifluoromethyl)thioxanthene 10- n/a 25mg O
0025
Oxide) F

F F

Fluphenazine Dihydrochloride
N N

MM0114.00 Fluphenazine Dihydrochloride 146-56-5 500mg S

F
N
OH HCl
2

F F

Impurity A (EP): 2-[4-[3-[5-Oxo-2-(trifluoromethyl)-


10H-5 4-phenothiazin-10-yl]propyl]piperazin-1- N N

MM0114.01 yl]ethanol (Fluphenazine S-Oxide) 1674-76-6 100mg O


S

F
N
OH

Related compound A (USP): 10-3-[4-(2-Hydroxyethyl) F F

piperazin-1-yl]propyl-2-(trifluoromethyl)-10H-phenothiazine 5-

Impurity A (EP): 2-[4-[3-[5-Oxo-2-(trifluoromethyl)-


MM0114.01- 10H-5 4-phenothiazin-10-yl]propyl]piperazin-1- N N

yl]ethanol (Fluphenazine S-Oxide) 1674-76-6 25mg O


S

F
N
OH

0025 Related compound A (USP): 10-3-[4-(2-Hydroxyethyl) F F

piperazin-1-yl]propyl-2-(trifluoromethyl)-10H-phenothiazine 5-

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-270
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity B (EP): 2-[4-[3-[5,5-Dioxo-2-(trifluoromethyl)-


MM0114.05- 10H-5 6-phenothiazin-10-yl]propyl]piperazin-1- N N

yl]ethanol (Fluphenazine S,S-Dioxide) 1476-79-5 25mg O


O
S

F
N
OH

0025 Related compound B (USP): 10-3-[4-(2-Hydroxyethyl) F F

piperazin-1-yl]propyl-2-(trifluoromethyl)-10H-phenothiazine
F F

Impurity D (EP): 10,10'-[Piperazine-1,4-diylbis(propane- N


N

MM0114.07 2376-89-8 100mg N

3,1-diyl)]bis[2-(trifluoromethyl)-10H-phenothiazine] S
N

F F

F F

MM0114.07- Impurity D (EP): 10,10'-[Piperazine-1,4-diylbis(propane- N


N

2376-89-8 25mg N

0025 3,1-diyl)]bis[2-(trifluoromethyl)-10H-phenothiazine] S
N

F F

Impurity E (EP): 2-[4-[3-[2-Chloro-10H-phenothiazin- N N

MM0826.00 58-39-9 100mg S N

10-yl]propyl]piperazin-1-yl]ethanol (Perphenazine) Cl
OH

O HCl
+ 2
N N

Fluphenazine N,N',S-Trioxide Dihydrochloride


+
S N
MM0114.04 n/a 100mg O OH
O
F

F F

O HCl
+ 2
N N
MM0114.04-
Fluphenazine N,N',S-Trioxide Dihydrochloride
+
S N
n/a 25mg O OH
O
F
0025
F F

MM0114.15- N N
+
HCl
S N 2
OH
Fluphenazine N1-Oxide Dihydrochloride n/a 25mg F
O

0025 F F

MM0114.13- N N O
S N
O-Acetylfluphenazine 2021-89-8 25mg O
F
0025 F F

N N
MM0114.17- S NH HCl
Desmethyltrifluoperazine Dihydrochloride 4617-82-7 25mg 2
F
0025
F F

O
+
N N
MM0114.18- Fluphenazine Sulfone N1,N4-Dioxide (Fluphenazine O S N
+

86137-45-3 25mg OH
O O
F
0025 N1,N4,S,S-Tetraoxide)
F F

NH
MM0441.10- O S
2-(Trifluoromethyl)-10H-phenothiazine 5,5-Dioxide 345-38-0 25mg
0025 O
F

F F

Flupirtine Maleate
F O
H

Flupirtine Maleate N N NH2 OH


O
OH
MM1245.00 75507-68-5 100mg N
H
O
O

F
H
N N NH2
O
MM1245.04 Flupirtine 56995-20-1 100mg N O
H

F
H H
MM1245.02- 5-[(4-Fluorobenzyl)amino]-1H-imidazo[4,5-b]pyridin-2(3H)- N N N
951624-49-0 25mg O
0025 one N
H

Flurandrenolide
OH
O

HO O

MM1873.00 Flurandrenolide 1524-88-5 250mg H O

H H
O
F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-271
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Flurazepam Dihydrochloride
N

O
N
MM3604.00-
Flurazepam Dihydrochloride 1172-18-5 CS 250mg N
HCl
2
Cl
0250
F

Flurazepam Monohydrochloride
N

O
N

MM0070.00 Flurazepam Monohydrochloride 36105-20-1 CS 250mg HCl

Cl N

H O
Impurity B (EP): 7-Chloro-5-(2- N

fluorophenyl)-1,3-dihydro-2H-1,4-
Cl N
MM0070.02 benzodiazepin-2-one 2886-65-9 100mg
Related compound F (USP): 7-chloro-5-(2-fluorophenyl)- F

1,3-dihydro-2H-1,4-benzodiazepin-2-one
H O
Impurity B (EP): 7-Chloro-5-(2- N

fluorophenyl)-1,3-dihydro-2H-1,4-
MM0070.02- Cl N
benzodiazepin-2-one 2886-65-9 25mg
0025 Related compound F (USP): 7-chloro-5-(2-fluorophenyl)- F

1,3-dihydro-2H-1,4-benzodiazepin-2-one

2-Chloro-10-(2-diethylaminoethyl)-9,10- N
MM0070.03
dihydroacridin-9-one
97716-04-6 100mg
Cl
O

MM0070.03- 2-Chloro-10-(2-diethylaminoethyl)-9,10- N
dihydroacridin-9-one
97716-04-6 25mg
0025
Cl
O

O
N

MM0070.06 Flurazepam 17617-23-1 CS 100mg


Cl N

Cl

MM0070.07-
2-Hydroxyethylflurazepam 20971-53-3 25mg
0025 N
F N
OH
O

Flurbiprofen
F OH

MM0727.00 Flurbiprofen 5104-49-4 250mg O

Impurity A (EP): (2RS)-2-(Biphenyl-4-yl)propanoic OH

MM0727.01 Acid 6341-72-6 50mg O

Related compound A (USP): 2-(4-Biphenylyl)propionic Acid

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-272
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HO
F OH
Impurity C (EP): (2RS)-2-(2-Fluorobiphenyl-4-yl)- O
MM0727.03 61466-95-3 50mg
2-hydroxypropanoic Acid

F O

MM0727.06 Flurbiprofen Isopropyl Ester 252846-89-2 100mg O

OH
F O

MM0727.07- Flurbiprofen 1,2-Propylene Glycol Esters (Mixture of Regio-


n/a 25mg OH

0025 and Stereoisomers) F O

F O
MM0727.09-
Flurbiprofen Methyl Ester 66202-86-6 25mg O
0025

F O

MM0727.10 Flurbiprofen Ethyl Ester 64858-90-8 100mg O

F O

O OH
MM0727.11- Flurbiprofen 1,3-Butylene Glycol Esters (Mixture of Regio-
F O OH
n/a 25mg
and Stereoisomers) O
0025
OH
F O
MM0727.12-
Flurbiprofen 2,3-Butylene Glycol Ester 2731709-38-7 25mg O

0025
OH
F O OH

O
Flurbiprofen 1,2,3-Propanetriol Esters (Mixture of Regio- and F O
MM0727.13 n/a 100mg OH
O
Stereoisomers) OH

Flutamide
F F
H
N
MM0161.00- F
Flutamide 13311-84-7 250mg O +O
0250 N
O

F F
Impurity A (EP): 4-Nitro-3-(trifluoromethyl)- H 2N
aniline F
+O
MM0161.03 393-11-3 100mg
Related compound A (USP): 4-nitro-3-(trifluoromethyl) N
aniline O

F F
Impurity A (EP): 4-Nitro-3-(trifluoromethyl)- H 2N
MM0161.03- aniline F
+O
Related compound A (USP): 4-nitro-3-(trifluoromethyl)
393-11-3 25mg
0025 N
aniline O

Impurity B (EP): N-[4-Nitro-3-(trifluoro- H


F F
N
methyl)phenyl]acetamide F
O +O
Related compound B (USP): N-[4-nitro-3-(trifluoromethyl)
MM0161.04 393-12-4 100mg
N

phenyl]acetamide O

Impurity B (EP): N-[4-Nitro-3-(trifluoro- H


F F
N
MM0161.04- methyl)phenyl]acetamide F
O +O
Related compound B (USP): N-[4-nitro-3-(trifluoromethyl)
393-12-4 25mg
0025 N

phenyl]acetamide O

F F
H
N
Impurity C (EP): N-[4-Nitro-3-(trifluoro- F
MM0161.05 13312-12-4 100mg O +O
methyl)phenyl]propanamide N
O

F F
H
N
MM0161.05- Impurity C (EP): N-[4-Nitro-3-(trifluoro- F
13312-12-4 25mg O +O
0025 methyl)phenyl]propanamide N
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-273
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

F F

F
MM0161.06 Impurity D (EP): 3-(Trifluoromethyl)aniline 98-16-8 100mg

N H2

F F
H
Impurity E (EP): 2-Methyl-N-[3-(trifluoro- N
F
MM0161.07 1939-27-1 100mg
methyl)phenyl]propanamide O

F F
H
MM0161.07- Impurity E (EP): 2-Methyl-N-[3-(trifluoro- N
F
1939-27-1 25mg
0025 methyl)phenyl]propanamide O

F F
H
MM0161.08- Impurity F (EP): 2-Methyl-N-[2-nitro-5- N
F
151262-93-0 25mg
0025 (trifluoromethyl)phenyl]propanamide O
O2N

HO F F
2-Hydroxy-2-methyl-N-[4-nitro-3- H
N
F
MM0161.01 (trifluoromethyl)phenyl]propanamide 52806-53-8 100mg O
N
+O

(2-Hydroxyflutamide) O

HO F F

MM0161.01- 2-Hydroxy-2-methyl-N-[4-nitro-3- H
N
F
(trifluoromethyl)phenyl]propanamide 52806-53-8 25mg O
N
+O
0025 (2-Hydroxyflutamide) O

F F

MM0161.09 Trifluoromethylbenzene 98-08-8 100mg F

O F F
+
N
MM0161.10 3-Nitrobenzotrifluoride 98-46-4 100mg O F

F F

MM0161.11- F
2-Nitrotrifluoromethylbenzene 384-22-5 25mg
0025 +O
N
O

F F
HO
MM0161.12- F
3-Trifluoromethyl-4-nitrophenol 88-30-2 25mg +O
0025 N
O

Fluticasone Furoate
F

O S
O
O
MM3909.00- HO

Fluticasone Furoate 397864-44-7 250mg H


O

0250 F H
O
F

Fluticasone Propionate
O
S
F
HO O
MM1244.00- H
Fluticasone Propionate 80474-14-2 250mg F H
O

0250 O
F

O
OH
Impurity A (EP): 6 ,9-Difluoro-11 -hydroxy-16 -methyl-3- HO O
MM1244.01- H
O
oxo-17-(propanoyloxy)androsta-1,4-diene-17 -carboxylic 65429-42-7 25mg F H
0025 O
Acid F

Impurity D (EP): 6 ,9-Difluoro-11 -hydroxy-16 -methyl-17-


O
[(methylsulfanyl)carbonyl]-3-oxoandrosta-1,4-dien-17 -yl HO
S

O
MM1244.04- Propanoate 73205-13-7 25mg
H
O

0025 Related compound D (USP): S-methyl 6alpha, 9alpha-difluoro- O


F H

11beta-hydroxy-16alpha-methyl-3-oxo-17alpha- F

propionyloxyandrosta-1,4-diene-17beta-carbothioate

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-274
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
S
Impurity F (EP): 6 ,9-Difluoro-17-[[(fluoromethyl)- O O
F

MM1244.06- H

sulphanyl]carbonyl]-16 -methyl-3,11-dioxo- 1219174-94-3 25mg F H


O

0025
androsta-1,4-dien-17 -yl Propanoate O
F

6 ,9 -Difluoro-11 ,17 -dihydroxy-16 -methyl- O


OH

MM1244.10- 3-oxoandrosta-1,4-diene-17 -carboxylic Acid HO


H
OH

Related compound J (USP): 6alpha, 9alpha-difluoro- 28416-82-2 25mg F H


0025
11beta,17alpha-dihydroxy-16alpha-methyl-3-oxoandrosta- O
F
1,4-diene-17beta-carboxylic acid
S
O O
6 ,9 -Difluoro-11 -hydroxy-16 -methyl-2',3,4'-trioxo-17 - HO O
MM1244.11- H
spiro(androsta-1,4-diene-17,5'-(1,3)oxathiolane) 219719-95-6 25mg F H
0025 O
Related compound B (USP) F

O
SH
HO O
MM1244.14- 6 ,9-Difluoro-11 -hydroxy-16 -methyl-3-oxo-17- H
O
80474-45-9 25mg F H
0025 (propanoyloxy)androsta-1,4-diene-17 -carbothioic Acid O
F

Flutrimazole

MM3598.00 Flutrimazole 119006-77-8 250mg F


F N

Fluvastatin Sodium
AND Enantiomer
O
+
Na
OH O
MM0676.00-
Fluvastatin Sodium 93957-55-2 250mg N
OH

0250
F

Impurity B (EP) as Racemate: 1,1-Dimethylethyl


(3RS,5SR,6E)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H- AND Enantiomer

indol-2-yl]-3,5-dihydroxyhept-6-enoate (Fluvastatin tert-Butyl OH


O

MM0676.03 Ester) 129332-29-2 100mg N


OH

Related compound B (USP): [R*,S*-E]-(+/-)-7-[3-(4- F

fluorophenyl)-1-methylethyl-1H-indol-2-yl]-3,5-dihydroxy-6-
heptenoic acid 1,1, dimethylethyl ester
Impurity B (EP) as Racemate: 1,1-Dimethylethyl
(3RS,5SR,6E)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H- AND Enantiomer

MM0676.03- indol-2-yl]-3,5-dihydroxyhept-6-enoate (Fluvastatin tert-Butyl OH


O

Ester) 129332-29-2 25mg N


OH

0025 Related compound B (USP): [R*,S*-E]-(+/-)-7-[3-(4- F

fluorophenyl)-1-methylethyl-1H-indol-2-yl]-3,5-dihydroxy-6-
heptenoic acid 1,1, dimethylethyl ester
O

Impurity D (EP): (6E)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)- O OH

MM0676.01- N
OH
1H-indol-2-yl]-3-hydroxy-5-oxohept-6-enoic Acid (5- 1160169-39-0 25mg
0025
Ketofluvastatin) F

AND Enantiomer
O

OH O

N
OH
MM0676.09 Fluvastatin Methyl Ester 93957-53-0 100mg
F

AND Enantiomer
O

OH O
MM0676.09- N
OH
Fluvastatin Methyl Ester 93957-53-0 25mg
0025
F

AND Enantiomer
O

OH O
N
OH
MM0676.10 Fluvastatin Ethyl Ester 615263-37-1 100mg
F

AND Enantiomer
O

OH O
MM0676.10- N
OH
Fluvastatin Ethyl Ester 615263-37-1 25mg
0025
F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-275
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

AND Enantiomer
O

OH O
MM0676.11- N
OH
Fluvastatin Isopropyl Ester 615263-39-3 25mg
0025
F

N
MM0676.14- O
(E)-3-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]
93957-50-7 25mg
0025 prop-2-enal
F

Fluvoxamine Maleate
O O
N NH2
OH

MM0058.00 Fluvoxamine Maleate 61718-82-9 250mg F


O
OH

O
F F

Impurity D (EP): 5-Methoxy-1-[4-(trifluoromethyl)phenyl] O


MM0058.04 61718-80-7 100mg F
pentan-1-one F F

MM0058.04- Impurity D (EP): 5-Methoxy-1-[4-(trifluoromethyl)phenyl] O


61718-80-7 25mg F
0025 pentan-1-one F F

OH
N

Impurity I (EP): (E)-N-[5-Methoxy-1-[4-(trifluoromethyl) O


MM0058.09 61747-22-6 100mg
phenyl]pentylidene]hydroxylamine F

F F

OH
N

MM0058.09- Impurity I (EP): (E)-N-[5-Methoxy-1-[4-(trifluoromethyl) O


61747-22-6 25mg
0025 phenyl]pentylidene]hydroxylamine F

F F

MM1439.00- OH
Maleic Acid 110-16-7 250mg
0250 OH

Folic Acid Hydrate


O OH
O

O N

MM0621.00 Folic Acid 59-30-3 500mg N


N
N
H
H

O
OH

H2 N N N
H

O OH

MM0621.01- Impurity A (EP): (2S)-2-[(4-Aminobenzoyl)- O

amino]pentanedioic Acid 4271-30-1 25mg H 2N


N
H
OH
0025 (N-(4-Aminobenzoyl)-L-glutamic Acid) O

Impurity B (EP) as Sulphate: 2,5,6- N


N H2
x HO
O
S OH
MM0621.02 39267-74-8 100mg
Triaminopyrimidin-4(1H)-one Sulphate H 2N N
H
N H2 O

MM0621.02- Impurity B (EP) as Sulphate: 2,5,6- N


N H2
x HO
O
S OH
39267-74-8 25mg
0025 Triaminopyrimidin-4(1H)-one Sulphate H 2N N
H
N H2 O

MM0621.04- Impurity D (EP): 4-[[(2-Amino-4-oxo-1,4- O


O

OH

dihydropteridin-6-yl)methyl]amino]benzoic 119-24-4 25mg N


N
N
H
0025 Acid (Pteroic Acid) H2 N N
H
N

MM0094.03 4-Aminobenzoic Acid 150-13-0 100mg OH

H 2N

NH2
MM0169.00- H 2N OH
L-Glutamine 56-85-9 250mg
0250 O O

O O
N
MM0621.09- N
6-Formylpterin 712-30-1 25mg
0025 H 2N N N
H

O
N
N OH
MM0621.10 6-Hydroxymethylpterin 712-29-8 50mg
H 2N N N
H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-276
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Formestane
O

MM0389.00 Formestane 566-48-3 250mg H H


O
OH

Formoterol Fumarate Dihydrate


AND Enantiomer
O
OH
H HO
MM0447.00- N

Formoterol Fumarate Dihydrate


OH
O
183814-30-4 250mg HO
HN O
O
H2O
2
0250 2

AND Enantiomer
OH
H
N

MM0447.12 Formoterol 73573-87-2 100mg HO


O
O
H N

Impurity G (EP) as Hydrochloride: (2RS)-1-(4-Methoxy- H 2N

MM0447.07 phenyl)propan-2-amine Hydrochloride 3706-26-1 CS 100mg O


HCl

Related compound G (USP)


Impurity G (EP) as Hydrochloride: (2RS)-1-(4-Methoxy- H 2N
MM0447.07-
phenyl)propan-2-amine Hydrochloride 3706-26-1 CS 25mg O
HCl

0025 Related compound G (USP)


O
MM0460.10- HO
Fumaric Acid 110-17-8 250mg OH
0250 O

O
Br

MM0447.13 1-(4-Benzyloxy-3-nitrophenyl)-2-bromoethanone 43229-01-2 100mg O


+
N
O O

O
Br
MM0447.13-
1-(4-Benzyloxy-3-nitrophenyl)-2-bromoethanone 43229-01-2 25mg O
0025 +
N
O O

Foscarnet Sodium Hexahydrate


Impurity B (EP) as Disodium Salt: Disodium
O
MM3500.01- (Ethoxyoxydophosphanyl)formate O
Na
+
O P O
Related compound B (USP): (Ethoxyoxidophosphanyl)
55920-24-6 25mg 2
0025 O

formic acid
Impurity D (EP): Ethyl (Diethoxyphosphoryl)formate O
O

MM3500.02 Related compound D (USP): O,O-diethyl 1474-78-8 100mg O P O

ethoxycarbonylphosphonate O

Fosfomycin Calcium
O 2+
Ca
O
MM3457.00 Fosfomycin Calcium Monohydrate 26469-67-0 250mg P
H 2O
O O

Fosfomycin Trometamol
O
MM1566.01- +
Nitromethylidynetri(methanol) 126-11-4 25mg HO N O
0025 HO OH

Fosinopril Sodium
+
Na
O
O O
O
MM0645.00- H P

Fosinopril Sodium 88889-14-9 250mg O


O
N

0250 O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-277
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP): (2S,4S)-4-Cyclohexyl-1-[[(RS)-hydroxy(4-


phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic Acid O
OH
O O
P
MM0645.02- ((4S)-4-Cyclohexyl-[(4-phenylbutyl)phosphinyl]acetyl-L- N
HO
95399-71-6 25mg
0025 proline; Fosinoprilat)
Related compound A (USP): (4S)-4-cyclohexyl-[(4-
phenylbutyl)phosphinyl]acetyl-L-proline
(4-Phenylbutyl)phosphonic Acid OH
MM0645.01 46348-61-2 100mg P
Related compound H (USP): 4-phenylbutyl phosphonic acid O OH

MM0645.01- (4-Phenylbutyl)phosphonic Acid OH


46348-61-2 25mg P
0025 Related compound H (USP): 4-phenylbutyl phosphonic acid O OH

2-[Hydroxy(4-phenylbutyl)phosphoryl]acetic Acid Disodium


MM0645.05- Salt O O +
Na
n/a 25mg P
+ O
0025 Related compound G (USP): (4-phenylbutyl)phosphinyl Na O

acetic acid

MM0645.09- O O
P
[2-(Benzyloxy)-2-oxoethyl](4-phenylbutyl)phosphinic Acid 87460-09-1 25mg O
HO
0025

Frovatriptan Succinate Monohydrate


O O
S
[(1S,4R)-7,7-Dimethyl-2-oxo-bicyclo[2.2.1]hept-1-yl] OH
MM3979.03-
methanesulfonic Acid ((+)-10-Camphorsulfonic Acid; D- 3144-16-9 25mg O
0025
Camphorsulfonic Acid)

Fructose
Mixed
O
OH
MM1562.00 Fructose 57-48-7 250mg HO
&1
OH
HO OH

Fulvestrant
OH

Fulvestrant
H
O F F
H H
MM3296.00 129453-61-8 100mg HO
S

F F
F

OH

MM3296.01- Impurity B (EP): 7 -[9-[(4,4,5,5,5-Pentafluoropentyl)sulfonyl] H


O O F F
H H
98008-06-1 25mg HO
S

F F
F

0025 nonyl]estra-1,3,5(10)-triene-3,17 -diol (Fulvestrant Sulfone)

Fumaric Acid
O
MM0460.10- HO
Fumaric Acid 110-17-8 250mg OH
0250 O

O
HO
MM0352.03 Monomethyl Fumarate 2756-87-8 100mg O
O

O
MM0352.03- HO
Monomethyl Fumarate 2756-87-8 25mg O
0025 O

Furaltadone
O
+
N
N
N O O

MM1753.00 Furaltadone 139-91-3 100mg N O


O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-278
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
+
N
N
N O O
O
+
MM1753.02 Furaltadone N-Oxide Hydrochloride n/a 100mg N O HCl
O

O
+
N
MM1753.02- N
N O O
O
+
Furaltadone N-Oxide Hydrochloride n/a 25mg N O HCl
O
0025 O

Furosemide
Cl O O
S
MM0014.00- NH2
O
Furosemide 54-31-9 250mg N
0250 H
HO O

O OH
Impurity A (EP): 2-Chloro-4-[(furan-2-ylmethyl)amino]-5-
Cl
MM0014.02- sulphamoylbenzoic Acid
4818-59-1 25mg H 2N
0025 Related compound A (USP): 2-Chloro-4-N-furfurylamino-5- S
O O HN
sulfamoylbenzoic Acid O

O OH

Cl
Impurity B (EP): 2,4-Dichloro-5-
MM0014.03 2736-23-4 100mg
sulphamoylbenzoic Acid H 2N
S
O O Cl

O OH

Cl
MM0014.03- Impurity B (EP): 2,4-Dichloro-5-
2736-23-4 25mg
0025 sulphamoylbenzoic Acid H 2N
S
O O Cl

O OH
Impurity C (EP): 2-Amino-4-chloro-5-
N H2
MM0014.01- sulphamoylbenzoic Acid
Related compound B (USP): 4-Chloro-5-
3086-91-7 25mg H 2N
0025 S
sulfamoylanthranilic Acid O O Cl

O OH
H
Impurity D (EP): 2,4-Bis[(furan-2-ylmethyl)amino]- N
O
MM0014.04 5046-19-5 100mg H 2N
5-sulphamoylbenzoic Acid O
S
O HN
O

O OH
H
MM0014.04- Impurity D (EP): 2,4-Bis[(furan-2-ylmethyl)amino]- N
O
5046-19-5 25mg H 2N
0025 5-sulphamoylbenzoic Acid O
S
O HN
O

O OH

Cl
MM0014.05 Impurity E (EP): 2,4-Dichlorobenzoic Acid 50-84-0 100mg

Cl
O OH
H
Impurity F (EP): 4-Chloro-5-sulfamoyl-2-[[((2RS)- N
O
MM0014.07 4793-38-8 100mg
tetrahydrofuran-2-yl)methyl]amino]benzoic Acid H 2N
S
O O Cl

O OH
H
MM0014.07- Impurity F (EP): 4-Chloro-5-sulfamoyl-2-[[((2RS)- N
O
4793-38-8 25mg
0025 tetrahydrofuran-2-yl)methyl]amino]benzoic Acid H 2N
S
O O Cl

O O

Cl
MM0014.50 Ethyl 2,4-Dichloro-5-sulphamoylbenzoate 4793-25-3 100mg H 2N
S
O O Cl

O O

Cl
MM0014.50-
Ethyl 2,4-Dichloro-5-sulphamoylbenzoate 4793-25-3 25mg H 2N
0025 S
O O Cl

MM0877.31-
2-Hydroxymethylfuran 98-00-0 100mg HO
0100 O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-279
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Fusidic Acid
O

H OH
HO

MM0832.00 Fusidic Acid Hemihydrate 172343-30-5 250mg H


O

O
H2 O

HO
H
2

Gabapentin
O
H2 N

MM0684.00 Gabapentin 60142-96-3 100mg OH

O
H
N
Impurity A (EP): 2-Azaspiro[4.5]decan-3-one
MM0684.01-
(3,3-Pentamethylene-4-butyrolactam) 64744-50-9 25mg
0025 Related compound A (USP): 2-Azaspiro[4.5]decan-3-one

O O
Impurity E (EP): 1-(Carboxymethyl)cyclo- HO
MM0684.07- hexanecarboxylic Acid OH
Related compound E (USP): carboxymethyl-
67950-95-2 25mg
0025
cyclohexanecarboxylic acid
HO NH2

MM0684.03- O O
1,1-Cyclohexanediacetic Acid Monoamide 99189-60-3 25mg
0025

H
O N O

MM0684.08- 1,1-Cycohexanediacetimide (3,3-Penta-


1130-32-1 25mg
0025 methyleneglutarimide)

O
H2 N
MM0684.09 2-(1-Aminocyclohexyl)acetic Acid Hydrochloride 37631-92-8 100mg OH

O
H2 N
MM0684.09- OH
2-(1-Aminocyclohexyl)acetic Acid Hydrochloride 37631-92-8 25mg
0025

O
H2 N
MM0684.12- O HCl
Gabapentin Ethyl Ester Hydrochloride 60175-04-4 25mg
0025
O
H2 N
MM0684.14- O HCl
Gabapentin Methyl Ester Hydrochloride 63562-01-6 25mg
0025

Galantamine Hydrobromide
H
O OH
O

MM1256.00 Galantamine Hydrobromide 1953-04-4 250mg HBr

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-280
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Gallamine Triethiodide
+
N

Gallamine Triethiodide
O

+ O O +
MM0140.00 65-29-2 250mg N N

I
3

Ganciclovir
O

HN N

MM0485.00 Ganciclovir 82410-32-0 100mg H 2N N N


O OH

HO

MM0485.02- Impurity A (EP): 2-Amino-9-[[(2-chloroprop-2- HN


N

en-1-yl)oxy]methyl]-1,9-dihydro-6H-purin- 1797982-93-4 25mg H 2N N N


0025 6-one (Vinylchloroganciclovir) O
Cl

O
Impurity B (EP): (2RS)-2-[(2-Amino-6-oxo-1,6-dihydro-9H- HN
N
MM0485.03- N
H 2N N
purin-9-yl)methoxy]-3-hydroxy-propyl Propionate (Ganciclovir 194159-18-7 25mg O
0025 O

Monopropionate) HO O

N
Impurity C (EP): 2-Amino-9-[[(1RS)-2-chloro-1- HN
MM0485.04- N
(hydroxymethyl)ethoxy]methyl]-1,9-dihydro-6H-purin-6-one 108436-36-8 25mg H 2N N
0025 O
Cl
(Monochloroganciclovir) HO

O
H
Impurity F (EP): 2-Amino-1,9-dihydro-6H-purin- HN
N
MM0061.02 73-40-5 100mg
6-one (Guanine)
H 2N N N

HO
Impurity H (EP): 2-Amino-7-[[2-hydroxy-1-(hydroxy- O
MM0485.08- O OH
methyl)ethoxy]methyl]-1,7-dihydro-6H-purin-6- 84222-50-4 25mg HN
N
0025 one (N-7 Isomer of Ganciclovir) H2 N N N

N
Impurity I (EP): 2-[(2-Amino-6-oxo-1,6-dihydro- H 2N
HN

N N

MM0485.09 9H-purin-9-yl)methoxy]-propane-1,3-diyl 86357-20-2 100mg O O


O

Dipropanoate (Ganciclovir Dipropionate) O

MM0485.09- Impurity I (EP): 2-[(2-Amino-6-oxo-1,6-dihydro- H 2N


HN

N N

9H-purin-9-yl)methoxy]-propane-1,3-diyl 86357-20-2 25mg O O


O
0025 Dipropanoate (Ganciclovir Dipropionate) O

Impurity J (EP): 2-[2-(Propanoylamino)-6-oxo-1,6- O HN


N

N
N N

MM0485.10 dihydro-9H-purin-9-yl]methoxy]propane-1,3- 177216-32-9 100mg H O O


O
O
diyl dipropanoate (Ganciclovir Tripropionate) O

MM0485.10- Impurity J (EP): 2-[2-(Propanoylamino)-6-oxo-1,6- O HN


N

N
N N

dihydro-9H-purin-9-yl]methoxy]propane-1,3- 177216-32-9 25mg H O O


O
O
0025 diyl dipropanoate (Ganciclovir Tripropionate) O

N
HN
MM0485.11- H 2N N N N HCl
Ganciclovir Mono-N-methyl Valinate Hydrochloride 1401562-16-0 25mg H
O O
0025 O
HO

N
HN

H2 N N N
MM0485.12 Ganciclovir Mono-O-acetate 88110-89-8 100mg O O
O
HO

N
HN
MM0485.12- N
Ganciclovir Mono-O-acetate 88110-89-8 25mg H2 N N
O O
0025 O
HO

N
HN

MM0485.13- H 2N N N
O O
Ganciclovir Di-O-acetate 86357-19-9 25mg O
0025 O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-281
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HN N
O

MM0485.14- N N N
H
Ganciclovir Triacetate 86357-14-4 25mg O O

0025 O O

O
2-[[2-(Acetylamino)-6-oxo-1,6-dihydro-9H-purin-9-yl] O HN
N
MM0485.15- N
N N
methoxy]-3-hydroxypropyl Acetate (Ganciclovir N,O- 298197-26-9 25mg H O O
0025 O

Diacetate) HO

HN N
O
MM0485.17- N-[9-[[2-Hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6-oxo-1H- N
84245-12-5 25mg N N
H
O
0025 purin-2-yl]acetamide (Ganciclovir N-Acetate) OH

HO

Gatifloxacin
OH

1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-hydroxy-4-oxo-3- F N
MM0885.01 154093-72-8 100mg
quinolinecarboxylic Acid OH
F
O O

OH

MM0885.01- 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-hydroxy-4-oxo-3- F N
154093-72-8 25mg
0025 quinolinecarboxylic Acid OH
F
O O

O
MM0885.16- 1-Cyclopropyl-6,7-difluoro-8-methoxy-4-oxo-1,4- F N
112811-71-9 25mg O
0025 dihydroquinoline-3-carboxylic Acid Ethyl Ester F
O O

Gefitinib
O N

Gefitinib
N O

MM3563.00 184475-35-2 250mg O HN Cl

O N
MM3563.02- Impurity A (EP): 7-Methoxy-6-[3-(morpholin-4-yl)propoxy] NH
199327-61-2 25mg N O
O O
0025 quinazolin-4(3H)-one
O N

MM3563.03- N
Impurity B (EP): N-(4-Chloro-3-fluorophenyl)-7-methoxy-6-[3- N O

1603814-04-5 25mg O HN F

0025 (morpholin-4-yl)propoxy]quinazolin-4-amine Cl

O N
O
+ N
N O
MM3563.01 Gefitinib N-Oxide 847949-51-3 100mg O HN Cl

H2 N Cl
MM3563.04-
3-Chloro-4-fluoroaniline 367-21-5 25mg
0025 F

O N

MM3563.05- N
4-Chloro-7-methoxyquinazolin-6-yl Acetate 230955-75-6 25mg O
0025 Cl
O

O N

N
MM3563.06- 4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxyquinazolin-6-ol HO
184475-71-6 25mg HN Cl
0025 (O-Desmorpholinopropylgefitinib)
F

O N

MM3563.07- NH
6-(Acetyloxy)-7-methoxyquinazolin-4(3H)-one 179688-53-0 25mg O
0025 O
O

MM3563.09- N Cl
HCl
4-(3-Chloropropyl)morpholine Hydrochloride 57616-74-7 25mg O
0025
O
MM3563.11-
3-Hydroxy-4-methoxybenzaldehyde 621-59-0 25mg O
0025 HO

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-282
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
MM3563.12- O
4-Methoxy-3-[3-(morpholin-4-yl)propoxy]benzaldehyde 861453-11-4 25mg N O
O
0025
O N

N
MM3563.15- O
N-(3-Chloro-4-fluorophenyl)-6,7-dimethoxyquinazolin-4-amine 153437-78-6 25mg HN Cl
0025
F

O N
MM3563.22- N
4-Chloro-7-methoxy-6-[3-(morpholin-4-yl)propoxy]quinazoline 199327-59-8 25mg N O

0025 O Cl

O N
MM3563.23- NH
6-Hydroxy-7-methoxy-4(1H)-quinazolinone 179688-52-9 25mg HO
0025 O

Gemcitabine Hydrochloride
N H2

MM1257.00- O N
Gemcitabine Hydrochloride 122111-03-9 250mg F
HCl
0250 O F

HO OH

NH2

MM0749.05- Impurity A (EP): 4-Aminopyrimidin-2(1H)-one N


71-30-7 25mg
0025 (Cytosine)
O N
H

HN
Impurity C (EP): 1-(2-Deoxy-2,2-difluoro- -D-erythro-
O N
MM1257.04 pentofuranosyl)pyrimidin-2,4(1H,3H)-dione (2 -Deoxy-2 ,2 - 114248-23-6 100mg
F
difluorouridine) O F

HO OH

HN
Impurity C (EP): 1-(2-Deoxy-2,2-difluoro- -D-erythro-
MM1257.04- O N
pentofuranosyl)pyrimidin-2,4(1H,3H)-dione (2 -Deoxy-2 ,2 - 114248-23-6 25mg
F
0025 difluorouridine) O F

HO OH

HN

MM1257.05- O N OH
(6RS)-2'-Deoxy-2',2'-difluoro-5,6-dihydro-6-hydroxyuridine n/a 25mg
0025 F
O F

HO OH

NH

(3R,4R,6R)-5,5-Difluorohexahydro-4-hydroxy-3,6-Epoxy- O N O
MM1257.06 294177-31-4 25mg O
2H,8H-pyrimido[6,1-b][1,3]oxazocine-8,10(9H)-dione H
H F
HO F

MM1257.07- N NH O
N4-Acetylcytosine 14631-20-0 25mg
0025
N
H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-283
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
O
O
MM1257.08- 2-Deoxy-2,2-difluoro-D-erythro-pentofuranos-1-ulose-3,5- O
122111-01-7 25mg F
0025 dibenzoate O F

O
O N
O NH2
O N
MM1257.09- O
2'-Deoxy-3',5'-di-O-benzoyl-2',2'-difluorocytidine 134790-39-9 25mg F
O F
0025

Gemfibrozil
O OH
MM0641.00 Gemfibrozil 25812-30-0 250mg O

OH
MM0641.08 Impurity A (EP): 2,5-Dimethylphenol (p-Xylenol) 95-87-4 100mg

OH
MM0641.08-
Impurity A (EP): 2,5-Dimethylphenol (p-Xylenol) 95-87-4 25mg
0025

Impurity E (EP) as (E)-Isomer: 5-[2,5-Dimethyl-4-[(E)-prop-1- O OH

MM0641.07 1315604-10-4 100mg


enyl]phenoxy]-2,2-dimethylpentanoic Acid O

MM0641.07- Impurity E (EP) as (E)-Isomer: 5-[2,5-Dimethyl-4-[(E)-prop-1- O OH

1315604-10-4 25mg
0025 enyl]phenoxy]-2,2-dimethylpentanoic Acid O

Impurity E (EP): 5-[2,5-Dimethyl-4-(prop-1-enyl)phenoxy]-2,2-


MM0641.13- dimethylpentanoic Acid O OH

500904-61-0 25mg O
0025 Related compound A (USP): (E,Z)-2,2-dimethyl-5-[2,5-
dimethyl-4-(propene-1-yl)phenoxy]valeric acid
Impurity H (EP): 1,3-Bis(2,5-dimethylphenoxy)- O O

MM0641.02 415724-02-6 100mg


propane

MM0641.02- Impurity H (EP): 1,3-Bis(2,5-dimethylphenoxy)- O O

415724-02-6 25mg
0025 propane

Impurity I (EP): Methyl 5-(2,5-dimethylphenoxy)-2,2- O O


MM0641.06 149105-25-9 100mg
dimethylpentanoate (Gemfibrozil Methyl Ester) O

O Cl
3-(2,5-Dimethylphenoxy)propyl Chloride
(3-(2,5-Xylyloxy)propyl Chloride)
MM0641.01 31264-51-4 100mg

O O
MM0641.03 Gemfibrozil Isobutyl Ester 149105-26-0 100mg O

O O

MM0641.14 Gemfibrozil Ethyl Ester 63258-18-4 100mg O

O O
MM0641.15 Gemfibrozil Isopropyl Ester 154021-24-6 100mg O

Genistein
HO O

MM0748.00 Genistein 446-72-0 250mg


OH O
OH

Gestodene
OH

MM0124.00-
Gestodene 60282-87-3 250mg H H

0250 H H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-284
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
Impurity L (EP): 13-Ethyl-17-hydroxy-18,19-
H H
MM0124.06 dinor-17 -pregna-5,15-dien-20-yn-3-one n/a 100mg
H H
( 6)-Gestodene) O

OH
Impurity L (EP): 13-Ethyl-17-hydroxy-18,19-
MM0124.06- H H
dinor-17 -pregna-5,15-dien-20-yn-3-one n/a 25mg
0025 H H
( 6)-Gestodene) O

GHB Sodium Salt


GHB Sodium Salt O
+
MM1355.00 HO Na
(Sodium Gammahydroxybutyrate)
502-85-2 CS 100mg O

O
MM1275.51-
0100
Gammabutyrolactone (GBL) 96-48-0 100mg O

Glibenclamide (Glyburide)
O O O

MM0008.00- S
O N N
H H
Cl
Glibenclamide 10238-21-8 250mg N
H
0250 O

Impurity A (EP): 5-Chloro-2-methoxy-N-[2- O O

(4-sulfamoylphenyl)ethyl]benzamide Cl
O
S
N H2

Related compound A (USP): 4-[2-(5-chloro-2-


MM0008.01 16673-34-0 100mg N
H
O

methoxybenzamido)ethyl]benzenesulfonamide
Impurity A (EP): 5-Chloro-2-methoxy-N-[2- O O

MM0008.01- (4-sulfamoylphenyl)ethyl]benzamide Cl
O
S
N H2

Related compound A (USP): 4-[2-(5-chloro-2-


16673-34-0 25mg N
H
0025 O

methoxybenzamido)ethyl]benzenesulfonamide
Impurity B (EP): Methyl [[4-[2-[(5-Chloro-2-
methoxybenzoyl)amino]ethyl]phenyl]- O
O
S
O

N
O

MM0008.02 sulphonyl]carbamate 21165-77-5 100mg Cl


N
H
H

Related compound B (USP): methyl-[[4-[2-[(5-chloro-2- O

methoxybenzoyl)-amino]ethyl]phenyl]sulfonyl]carbamate
Impurity B (EP): Methyl [[4-[2-[(5-Chloro-2-
MM0008.02- methoxybenzoyl)amino]ethyl]phenyl]- O
O
S
O

N
O

sulphonyl]carbamate 21165-77-5 25mg Cl


N
H
H

0025 Related compound B (USP): methyl-[[4-[2-[(5-chloro-2- O

methoxybenzoyl)-amino]ethyl]phenyl]sulfonyl]carbamate
Impurity C (EP): 1-Cyclohexyl-3-[[4-[2-
[(cyclohexylcarbamoyl)amino]ethyl]phenyl]sulfonyl]urea (N- O
O O
S
N
H
O

N
H
MM0942.09 10079-35-3 100mg
(Cyclohexylcarbamoyl)-4-[2-[(cyclohexylcarbamoyl)amino] N
H
N
H

ethyl]benzenesulphonamide)
Impurity C (EP): 1-Cyclohexyl-3-[[4-[2-
MM0942.09- [(cyclohexylcarbamoyl)amino]ethyl]phenyl]sulfonyl]urea (N- O
O O
S
N
H
O

N
H
10079-35-3 25mg
0025 (Cyclohexylcarbamoyl)-4-[2-[(cyclohexylcarbamoyl)amino] N
H
N
H

ethyl]benzenesulphonamide)
Impurity D (EP): 1-Butyl-3-[[4-[2-[(5-chloro-2- O
O O

methoxybenzoyl)amino]ethyl]phenyl]sulfonyl]urea (1-[[4-[2- Cl
O

N
S
N
H
N
H
MM0008.07 38160-73-5 50mg
[(5-Chloro-2-methoxybenzoyl)amino]ethyl]phenyl]sulfonyl]-3- O
H

butylurea)
Impurity E (EP): 1-Cyclohexyl-3-[[4-[2-[(3,5-dichloro-2- O O O

MM0008.08- methoxybenzoyl)amino]ethyl]phenyl]sulfonyl]urea (1-[[4-[2- Cl


O

N
S
N
H
N
H

57334-89-1 25mg
[(3,5-Dichloro-2-methoxybenzoyl)amino]ethyl]phenyl]
H
O
0025 Cl

sulfonyl]-3-cyclohexylurea)
O
Cl
MM0008.03 5-Chloro-2-methoxybenzoic Acid 3438-16-2 100mg OH

O
MM0008.03- Cl
5-Chloro-2-methoxybenzoic Acid 3438-16-2 25mg OH
0025
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-285
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
5-Chloro-N-(2-phenylethyl)-2- Cl
N
methoxybenzamide
MM0008.04 33924-49-1 100mg H
O

Gliclazide
O O O
MM0325.00-
Gliclazide 21187-98-4 250mg S
N
H
N
H
N

0250
O O
S
MM0325.01 Impurity A (EP): 4-Methylbenzenesulphonamide 70-55-3 100mg NH2

Impurity B (EP): 2-Nitroso-octahydrocyclopenta- N N


MM0325.02 54786-86-6 100mg
[c]pyrrole O

O O O
Impurity C (EP): Ethyl [(4-Methylphenyl)sulphonyl]- S
N O
MM0325.03 5577-13-9 100mg H
carbamate
O O O
MM0325.03- Impurity C (EP): Ethyl [(4-Methylphenyl)sulphonyl]- S
N O
5577-13-9 25mg
0025 carbamate H

Impurity F (EP): 1-(Hexahydrocyclopenta[c]pyrrol- O O


S
O
N
MM0325.06 1076198-18-9 100mg N N
2(1H)-yl)-3-[(2-methylphenyl)sulphonyl]urea H H

MM0325.06- Impurity F (EP): 1-(Hexahydrocyclopenta[c]pyrrol- O O


S
O
N
1076198-18-9 25mg N N
0025 2(1H)-yl)-3-[(2-methylphenyl)sulphonyl]urea H H

O O O
S
MM0325.09 Methyl N-Methyl-p-tolylsulphoncarbamate 32258-50-7 100mg N O

O O O
MM0325.09- S
Methyl N-Methyl-p-tolylsulphoncarbamate 32258-50-7 25mg N O
0025

HCl
MM0325.10 Octahydrocyclopenta[c]pyrrole Hydrochloride 112626-50-3 100mg
HN

MM0325.10- HCl
Octahydrocyclopenta[c]pyrrole Hydrochloride 112626-50-3 25mg
0025 HN

O O O
N-Carbamoyl-2-methylbenzenesulfonamide (N- S
MM0325.11 39051-77-9 100mg N NH2
H
(Aminocarbonyl)-2-methylbenzenesulfonamide)
O O O
MM0325.11- N-Carbamoyl-2-methylbenzenesulfonamide (N- S
39051-77-9 25mg N NH2
H
0025 (Aminocarbonyl)-2-methylbenzenesulfonamide)

Glimepiride
O O O
S
MM0647.00- N N

Glimepiride 93479-97-1 250mg O


N
H H

0250 O N
H

Impurity A (EP): 1-[[4-[2-[[(3-Ethyl-4-methyl-2-


oxo-2,3-dihydro-1H-pyrrol-1-yl)carbonyl]- O O
S
N
O

MM0647.02 amino]ethyl]phenyl]sulphonyl]-3-(cis-4- 684286-46-2 100mg O


N
H H

methylcyclohexyl)urea (cis-Glimepiride) O N
H

Related compound A (USP): glimepiride cis-isomer


Impurity A (EP): 1-[[4-[2-[[(3-Ethyl-4-methyl-2-
MM0647.02- oxo-2,3-dihydro-1H-pyrrol-1-yl)carbonyl]- O O
S
N
O

amino]ethyl]phenyl]sulphonyl]-3-(cis-4- 684286-46-2 25mg O


N
H H

0025 methylcyclohexyl)urea (cis-Glimepiride) O N


H

Related compound A (USP): glimepiride cis-isomer

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-286
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity B (EP): 3-Ethyl-4-methyl-2-oxo-N-[2-(4-


sulphamoylphenyl)ethyl]-2,3-dihydro-1H-pyrrole- O O
S
1-carboxamide (Glimepiride Sulphonamide) N
O

N
NH2

Related compound B (USP): glimepiride sulfonamide, or 3-


MM0647.01 119018-29-0 100mg H

Ethyl-4-methyl-2-oxo-N-(4-sulfamoylphenethyl)-2,5-dihydro-
1H-pyrrole-1-carboxamide
Impurity B (EP): 3-Ethyl-4-methyl-2-oxo-N-[2-(4-
sulphamoylphenyl)ethyl]-2,3-dihydro-1H-pyrrole- O O
S
MM0647.01- 1-carboxamide (Glimepiride Sulphonamide) N
O

N
NH2

Related compound B (USP): glimepiride sulfonamide, or 3-


119018-29-0 25mg H
0025 O

Ethyl-4-methyl-2-oxo-N-(4-sulfamoylphenethyl)-2,5-dihydro-
1H-pyrrole-1-carboxamide
Impurity C (EP): Methyl [[4-[2-[[(3-Ethyl-4-methyl-2-
oxo-2,3-dihydro-1H-pyrrol-1-yl)carbonyl]amino]-
ethyl]phenyl]sulphonyl]carbamate (Glimepiride O
O
S
O

N
O

O
H

MM0647.03 Carbamate) 119018-30-3 100mg N N


H

Related compound C (USP): glimepiride urethane, or methyl O

((4-(2-(3-ethyl-4-methyl-2-oxo-2,5-dihydro-1H-pyrrole-1-
carboxamido)ethyl)phenyl)sulfonyl)carbamate
Impurity D (EP): 1-[[3-[2-[[(3-Ethyl-4-methyl-2-oxo-
2,3-dihydro-1H-pyrrol-1-yl)carbonyl]amino]ethyl]-
phenyl]sulphonyl]-3-(trans-4-methylcyclohexyl)- O
S
O

N
O

urea
H H

MM0647.04 791104-62-6 100mg N


H
N

Related compound D (USP): Glimepiride 3-isomer, or 1-[[m- O O

[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]
phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea
Impurity D (EP): 1-[[3-[2-[[(3-Ethyl-4-methyl-2-oxo-
2,3-dihydro-1H-pyrrol-1-yl)carbonyl]amino]ethyl]-
MM0647.04- phenyl]sulphonyl]-3-(trans-4-methylcyclohexyl)- O
S
O

N
O

urea
H H

791104-62-6 25mg N
H
N
0025 Related compound D (USP): Glimepiride 3-isomer, or 1-[[m- O O

[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]
phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea
HCl
MM0647.08 cis-4-Methylcyclohexylamine Hydrochloride 33483-66-8 100mg H2 N

MM0647.08- HCl
cis-4-Methylcyclohexylamine Hydrochloride 33483-66-8 25mg H2 N
0025

MM0647.17- 3-Ethyl-4-methyl-2-oxo-N-(2-phenylethyl)-2,5-dihydro-1H-
247098-18-6 25mg O
N
0025 pyrrole-1-carboxamide
O N
H

Glipizide
O O O

MM0942.00- S

Glipizide
O N N
H H
N
29094-61-9 250mg N
H
0250 N

Impurity A (EP): 5-Methyl-N-[2-(4-sulphamoyl- O O

phenyl)ethyl]pyrazine-2-carboxamide N
O
S
N H2

Related compound A (USP): N-2-[(4-aminosulfonyl)phenyl]


MM0942.01 33288-71-0 100mg N
H
N

ethyl-5-methyl-pyrazinecarboxamide
Impurity A (EP): 5-Methyl-N-[2-(4-sulphamoyl- O O

MM0942.01- phenyl)ethyl]pyrazine-2-carboxamide N
O
S
N H2

Related compound A (USP): N-2-[(4-aminosulfonyl)phenyl]


33288-71-0 25mg N
H
0025 N

ethyl-5-methyl-pyrazinecarboxamide
N H2
MM0678.03 Impurity B (EP): Cyclohexanamine 108-91-8 100mg

Impurity D (EP): 6-Methyl-N-[2-(4-sulphamoyl- O O

phenyl)ethyl]pyrazine-2-carboxamide N
O
S
N H2

Related compound B (USP): 6-methyl-N-[2-(4-


MM0942.04 1346600-54-1 100mg N
H
N

sulphamoylphenyl)ethyl]pyrazine-2-carboxamide

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-287
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity D (EP): 6-Methyl-N-[2-(4-sulphamoyl- O O

MM0942.04- phenyl)ethyl]pyrazine-2-carboxamide N
O
S
N H2

Related compound B (USP): 6-methyl-N-[2-(4-


1346600-54-1 25mg N
H
0025 N

sulphamoylphenyl)ethyl]pyrazine-2-carboxamide
Impurity E (EP): 1-Cyclohexyl-3-[[4-[2-[[(6-methyl-
pyrazin-2-yl)carbonyl]amino]ethyl]phenyl]- O O
S
O

sulphonyl]urea
O N N
H H
N
MM0942.05 66375-96-0 100mg N
H

Related compound C (USP): 1-cyclohexyl-3-[[4-[2-[[(6- N

methylpyrazin-2-yl)carbonyl]amino]ethyl]phenyl]sulfonyl]urea
Impurity E (EP): 1-Cyclohexyl-3-[[4-[2-[[(6-methyl-
MM0942.05- pyrazin-2-yl)carbonyl]amino]ethyl]phenyl]- O O
S
O

sulphonyl]urea
O N N
H H
N
66375-96-0 25mg N
H
0025 Related compound C (USP): 1-cyclohexyl-3-[[4-[2-[[(6- N

methylpyrazin-2-yl)carbonyl]amino]ethyl]phenyl]sulfonyl]urea
O O

Impurity F (EP): Ethyl [2-(4-Sulphamoylphenyl)- O


S
N H2
MM0942.06 192118-08-4 100mg
ethyl]carbamate O N
H

O O
MM0942.06- Impurity F (EP): Ethyl [2-(4-Sulphamoylphenyl)- O
S
N H2
192118-08-4 25mg
0025 ethyl]carbamate O N
H

Impurity G (EP): Methyl [[4-[2-[[(5-Methylpyrazin- O


O
S
O

N
O

MM0942.07 2-yl)carbonyl]amino]ethyl]phenyl]sulphonyl]- 33288-74-3 100mg N


N
H
H

carbamate N

MM0942.07- Impurity G (EP): Methyl [[4-[2-[[(5-Methylpyrazin- O


O
S
O

N
O

2-yl)carbonyl]amino]ethyl]phenyl]sulphonyl]- 33288-74-3 25mg N


N
H
H

0025 carbamate N

O O

Impurity H (EP): 4-[2-[(Cyclohexylcarbamoyl)amino]- O


S
N H2
MM0942.08 10080-05-4 100mg
ethyl]benzenesulphonamide N
H
N
H

O O
MM0942.08- Impurity H (EP): 4-[2-[(Cyclohexylcarbamoyl)amino]- O
S
N H2
10080-05-4 25mg
0025 ethyl]benzenesulphonamide N
H
N
H

Impurity I (EP): N-(Cyclohexylcarbamoyl)-4-[2- O O O


S

MM0942.09 [(cyclohexylcarbamoyl)amino]ethyl]benzene- 10079-35-3 100mg N


H
O

N
H
N
H
N
H

sulphonamide

MM0942.09- Impurity I (EP): N-(Cyclohexylcarbamoyl)-4-[2- O O O


S

[(cyclohexylcarbamoyl)amino]ethyl]benzene- 10079-35-3 25mg N


H
O

N
H
N
H
N
H

0025 sulphonamide
O O
MM0942.10- S
N H2
4-(2-Aminoethyl)benzenesulfonamide 35303-76-5 25mg
0025 H 2N

Gliquidone
O O O
S
O N N

MM3094.00 Gliquidone 33342-05-1 250mg O


N

O
H H

Glucosamine Hydrochloride
HO
O

MM0695.00 Glucosamine Hydrochloride 66-84-2 250mg HO O H HCl

HO N H2

N
MM0695.06 2-Methylpyrazine 109-08-0 100mg N

Glucose Monohydrate
Mixed
HO
O
MM0178.00 Glucose Monohydrate 14431-43-7 250mg HO &1
OH H2O

HO OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-288
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Glutamic Acid
NH2
HO OH
MM1333.00 Glutamic Acid (L-Glutamic Acid) 56-86-0 250mg
O O

Glutamine
NH2
MM0169.00- H 2N OH
L-Glutamine 56-85-9 250mg
0250 O O

N-Phenylacetyl-L-glutamine HN
MM0169.01 28047-15-6 100mg
(Phenylacetylglutamine) H 2N OH

O O

MM0169.01- N-Phenylacetyl-L-glutamine HN

(Phenylacetylglutamine)
28047-15-6 25mg H 2N OH
0025 O O

NH2

MM0169.02 Phenylacetamide 103-81-1 100mg O

NH2
MM0169.02-
Phenylacetamide 103-81-1 25mg O
0025
O
H
N
O
MM3413.01 Pidolic Acid (Pyroglutamic Acid) 98-79-3 250mg
OH

Glutathione
SH
O O O
H

MM1025.00 Glutathione 70-18-8 250mg HO


NH2
N
H
O
N
OH

Glyburide, see Glibenclamide

Glycerin, see Glycerol

Glycerol (Glycerin)
OH
MM1481.00 Impurity C (EP): (RS)-Propane-1,2-diol (Propylene Glycol) 57-55-6 250mg OH

Glycine
OH
MM1509.00- H 2N
Glycine 56-40-6 250mg
0250 O

O O
H
MM1509.01 Impurity A (EP): 2,2 -Iminodiacetic Acid (Iminodiacetic Acid) 142-73-4 100mg HO
N
OH

MM1509.01- O O
H
Impurity A (EP): 2,2 -Iminodiacetic Acid (Iminodiacetic Acid) 142-73-4 25mg HO
N
OH
0025

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-289
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

H
N O

MM0314.04 Impurity B (EP): Piperazine-2,5-dione (Glycine Anhydride) 106-57-0 100mg


O N
H

H
N O
MM0314.04-
Impurity B (EP): Piperazine-2,5-dione (Glycine Anhydride) 106-57-0 25mg
0025
O N
H

O
MM1509.02- Impurity H (EP): 2-[(2-Aminoacetyl)amino]acetic Acid H
N
556-50-3 100mg H 2N OH
0100 (Diglycine; N-Glycylglycine) O

O O
MM1509.03- Impurity I (EP): 2-[[2-[(2-Aminoacetyl)amino]acetyl]amino] H 2N
N
H
N
OH
556-33-2 25mg
0025 acetic Acid (Triglycine) H
O

MM1509.04- O
H2 N HCl
Glycine Ethyl Ester Hydrochloride 623-33-6 25mg O
0025

Glycocholic Acid
O
OH
H
MM3875.00- N OH
H H
O
Glycocholic Acid 475-31-0 250mg H H
0250 HO OH
H

O
OH
H
MM3875.01- N O
H H
O
Glycocholic Acid Ethyl Ester 517904-33-5 25mg H H

0025 HO OH
H

O
OH
H
OH
MM0835.02- H
3 ,7 ,12 -Trihydroxy-5 -cholan-24-oic Acid (Cholic Acid) 81-25-4 250mg H H
0250 HO
H
OH

O
OH
H
MM3875.02- N OH
H H
O
Glycodeoxycholic Acid 360-65-6 25mg H H
0025 HO
H

O
OH
H
MM3875.03- N O
H H
O
Glycodeoxycholic Acid Ethyl Ester 70779-06-5 25mg H H

0025 HO
H

MM1509.04- O
H2 N HCl
Glycine Ethyl Ester Hydrochloride 623-33-6 25mg O
0025

Glycopyrrolate, see Glycopyrronium Bromide

Glycopyrronium Bromide (Glycopyrrolate)


AND Enantiomer
Br
O +
N
MM0834.00 Glycopyrronium Bromide 51186-83-5 100mg OH
O

O
Impurity B (EP): Oxophenylacetic Acid
MM0834.05
(Benzoylformic Acid)
611-73-4 100mg OH
O

O
MM0834.05- Impurity B (EP): Oxophenylacetic Acid
(Benzoylformic Acid)
611-73-4 25mg OH
0025
O

O
Impurity C (EP): (2RS)-2-Hydroxy-2-phenylacetic
MM0792.03
Acid (Mandelic Acid)
90-64-2 100mg OH
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-290
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
MM0278.01-
Impurity D (EP): Benzoic Acid 65-85-0 250mg OH
0250

MM0528.05- O
Impurity F (EP): Benzaldehyde 100-52-7 500mg
0500

Impurity G (EP): 1-Methylpyrrolidin-3-yl 2- O


N
MM0834.12- Cyclopentyl-2-hydroxy-2-phenylacetate O

Related compound B (USP): 1-Methylpyrrolidin-3-yl 2-


13118-11-1 25mg OH
0025
cyclopentyl-2-hydroxy-2-phenylacetate
Impurity G (EP) as Hydrochloride: 1-Methylpyrrolidin-3-yl 2-
O
N
MM0834.16- Cyclopentyl-2-hydroxy-2-phenylacetate Hydrochloride O HCl
13118-10-0 25mg OH
0025 Related compound B (USP): 1-Methylpyrrolidin-3-yl 2-
cyclopentyl-2-hydroxy-2-phenylacetate
O
Impurity H (EP): Methyl 2-oxo-2-Phenylacetate
MM0834.07 15206-55-0 100mg O
(Methyl Benzoylformate)
O

Impurity J (EP): 2-(RS)-Cyclopentyl-2-hydroxy- O


2-phenylacetic Acid -Cyclopentylmandelic
MM0834.01- OH
Acid) 427-49-6 25mg OH
0025 Related compound C (USP): 2-Cyclopentyl-2-hydroxy-2-
phenylacetic acid
O

Impurity K (EP): (2RS)-2-Cyclopentyl-2-phenyl- OH


MM0834.08 3900-93-4 100mg
acetic Acid

MM0834.08- Impurity K (EP): (2RS)-2-Cyclopentyl-2-phenyl- OH


3900-93-4 25mg
0025 acetic Acid

Impurity L (EP): Methyl (2RS)-2-Cyclopentyl- O

MM0834.09- 2-hydroxy-2-phenylacetate O
Related compound L (USP): Methyl 2-cyclopentyl-2-
19833-96-6 25mg OH
0025
hydroxy-2-phenylacetate

O
MM0834.06 Impurity M (EP): Cyclopentylphenylmethanone 5422-88-8 100mg

AND Enantiomer

MM0834.14- Impurity N (EP) as Bromide: (3RS)-3-[(2RS)-(2- O +


N

Cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]- 58493-54-2 25mg OH


O Br

0025 1,1-dimethylpyrrolidinium Bromide


O +O
N
Impurity O (EP): 5-Nitroisophtalic Acid
MM0834.15-
Related compound A (USP): 5-Nitrobenzene-1,3- 618-88-2 25mg
HO OH
0025 dicarboxylic acid
O O

Glymidine Sodium
O
O O N O

MM1964.00 Glymidine Sodium 3459-20-9 50mg S


N
+
N

Na

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-291
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Granisetron Hydrochloride
H
N N
MM0398.00- H
N N HCl
Granisetron Hydrochloride 107007-99-8 250mg
O
0250 H

Impurity A (EP): 2-Methyl-N-[(1R,3r,5S)-9-methyl-9-


azabicyclo[3.3.1]non-3-yl]-2H-indazole-3-carboxamide H
N N
MM0398.01- H
N N
Related compound A (USP): 2-methyl-N-[(1R,3r,5S)-9- 127472-42-8 25mg
0025 O
H
methyl-9-azabicyclo[3.3.1]non-3-yl]-2H-indazole-3-
carboxamide
Impurity B (EP): N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1] H H
N
MM0398.02- non-3-yl]-1H-indazole-3-carboxamide 107007-95-4 25mg
N
H
N N

0025 Related compound B (USP): N-[(1R,3r,5S)-9-methyl-9- O


H

azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide
Impurity C (EP): N-[(1R,3r,5S)-9-Azabicyclo[3.3.1]non-3-yl]- H
N

MM0398.03 1-methyl-1H-indazole-3-carboxamide 160177-67-3 50mg


N
H
N NH

Related compound C (USP): N-[(1R,3r,5S)-9-azabicyclo[3.3.1] O


H
non-3-yl]-1-methyl-1H-indazole-3-carboxamide
Impurity D (EP): 1-Methyl-1H-indazole-3-carboxylic
N N
MM0398.04- Acid
OH
Related compound D (USP): 1-methyl-1H-indazole-3-
50890-83-0 25mg
0025
carboxylic acid O

H
Impurity E (EP): (1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]
nonan-3-amine H 2N N
MM0398.05
Related compound E (USP): (1R,3r,5S)-9-methyl-9-
76272-56-5 100mg
azabicyclo[3.3.1]nonan-3-amine acetate H

Impurity E (EP) as Acetate: (1R,3r,5S)-9-Methyl-9-azabicyclo H

MM0398.12- [3.3.1]nonan-3-amine Acetate H 2N N


O

Related compound E (USP): (1R,3r,5S)-9-methyl-9-


n/a 25mg OH
0025 H

azabicyclo[3.3.1]nonan-3-amine acetate
N N

MM0398.07 Impurity G (EP): 2-Methyl-2H-indazole-3-carboxylic Acid 34252-44-3 100mg OH

N N
MM0398.07-
Impurity G (EP): 2-Methyl-2H-indazole-3-carboxylic Acid 34252-44-3 25mg OH
0025
O

H
N N
MM0398.08-
Impurity H (EP): 1H-Indazole-3-carboxylic Acid 4498-67-3 25mg OH
0025
O

MM0398.09- Impurity I (EP): 1-Methyl-1H-indazole-3-carboxylic N N


O
N N

n/a 25mg
0025 Anhydride O O

H
N N
H +
N O N
MM0398.11 Granisetron N-Oxide 160177-68-4 50mg
O
H

Griseofulvin
Cl O
O O

MM0582.00 Griseofulvin 126-07-8 500mg O

O O

Guaiacol
OH
MM0354.04 Guaiacol 90-05-1 500mg
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-292
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
Impurity A (EP): Benzene-1,2-diol
MM0814.04 120-80-9 100mg
(Pyrocatechol)
OH

OH
MM0814.04- Impurity A (EP): Benzene-1,2-diol
120-80-9 25mg
0025 (Pyrocatechol)
OH

OH
MM0045.11 Impurity B (EP): Phenol 108-95-2 100mg

O
Impurity C (EP): 1,2-Dimethoxybenzene
MM0814.06 91-16-7 100mg
(Veratrole)
O

MM0814.08 Impurity E (EP): Methyl Benzoate 93-58-3 100mg O

MM1131.00 Impurity G (EP): 4-Methoxyphenol (Mequinol) 150-76-5 500mg


HO

O OH

MM0007.09 Impurity H (EP): 3-Methoxyphenol 150-19-6 100mg

OH
MM0641.08 2,5-Dimethylphenol (p-Xylenol) 95-87-4 100mg

OH
MM0641.08-
2,5-Dimethylphenol (p-Xylenol) 95-87-4 25mg
0025

OH
MM1132.04-
4-Methylphenol (p-Cresol) 106-44-5 100mg
0100

OH
MM0146.01 2,6-Dimethylphenol 576-26-1 100mg

MM0146.01- OH
2,6-Dimethylphenol 576-26-1 25mg
0025

Guaifenesin
OH
O OH
MM0354.00 Guaifenesin 93-14-1 500mg
O

OH
MM0354.04 Impurity A (EP): 2-Methoxyphenol (Guaiacol) 90-05-1 500mg
O

HO OH
Impurity B (EP): 2-(2-Methoxyphenoxy)- O
MM0354.01 14007-09-1 100mg
propane-1,3-diol (B-Isomer)
O

HO OH
MM0354.01- Impurity B (EP): 2-(2-Methoxyphenoxy)- O
14007-09-1 25mg
0025 propane-1,3-diol (B-Isomer)
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-293
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity C (EP): 1,1'-Oxybis[3-(2- OH OH


O O O

MM0354.02 methoxyphenoxy)propan-2-ol] 1797132-23-0 100mg O O

(Bisether)

MM0354.02- Impurity C (EP): 1,1'-Oxybis[3-(2- OH OH


O O O

methoxyphenoxy)propan-2-ol] 1797132-23-0 25mg O O


0025 (Bisether)
OH
Impurity D (EP): 1,3-Bis(2-methoxyphenoxy)- O O
MM0354.03 16929-60-5 100mg
propan-2-ol O O

OH
MM0354.03- Impurity D (EP): 1,3-Bis(2-methoxyphenoxy)- O O
16929-60-5 25mg
0025 propan-2-ol O O

O
MM0354.09- O
O
4-[(2-Methoxyphenoxy)methyl]-1,3-dioxolan-2-one 2049-21-0 25mg
0025
O

Guanoxan Sulfate
NH
O O O

MM1880.00 Guanoxan Sulfate 5714-04-5 50mg O


N
H
N H2
HO
S
OH

Halcinonide
Cl
O

HO O

MM3633.00 Halcinonide 3093-35-4 250mg H O

F H
O

Halobetasol Propionate
Cl
O O

HO O

MM3634.00 Halobetasol Propionate 66852-54-8 250mg F


H

H
O
F

Halofantrine Hydrochloride
Cl

F F

Cl F

MM0433.00 Halofantrine Hydrochloride 36167-63-2 100mg HCl

HO N

Cl

F F

MM0433.05- Cl F

Halofantrine N-Oxide 1348409-88-0 25mg


0025 +
HO N
O

Halometasone Monohydrate
O

HO OH
OH
MM3688.00- H

Halometasone Monohydrate 1310709-74-0 250mg Cl

F H
H2O

0250 O
F

Haloperidol
F
Cl

MM1165.00 Haloperidol 52-86-8 250mg O


N

OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-294
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity D (EP): 4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1- Cl

yl]-1-[4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]phenyl]
MM1165.04 butan-1-one 67987-08-0 100mg HO
N
N
Cl

Related compound A (USP): 4,4'-Bis[4-(p-chlorophenyl)-4- O


OH

hydroxypiperidino]-butyrophenone
Impurity D (EP): 4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1- Cl

MM1165.04- yl]-1-[4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]phenyl]
butan-1-one 67987-08-0 25mg HO
N
N
Cl

0025 Related compound A (USP): 4,4'-Bis[4-(p-chlorophenyl)-4- O


OH

hydroxypiperidino]-butyrophenone

Haloperidol Decanoate
F
Cl
N

MM1276.00 Haloperidol Decanoate 74050-97-8 250mg O


O

MM1276.12 Impurity L (EP): 1-(4-Fluorophenyl)ethanone 403-42-9 100mg


O

Harmine
NH

MM2562.01 Tetrahydroharmine 17019-01-1 100mg


O N
H

NH
MM2562.01-
Tetrahydroharmine 17019-01-1 25mg
0025 O N
H

Harpagoside
O

MM0370.01 Methyl trans-Cinnamate 1754-62-7 100mg O

O
MM0370.01-
Methyl trans-Cinnamate 1754-62-7 25mg O
0025

Heptaminol Hydrochloride
NH2
MM0653.01 Impurity A (EP): (2RS)-6-Methylhept-5-en-2-amine 22462-79-9 100mg

Heteronium Bromide
O
+
N Br

MM3090.00 Heteronium Bromide 7247-57-6 50mg OH


O

Hexachlorophene
OH OH
Cl Cl

MM1757.00 Hexachlorophene 70-30-4 250mg Cl Cl


Cl Cl

Hexestrol
OH

MM1662.00 Hexestrol 84-16-2 100mg


HO

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-295
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Hexetidine
NH2

MM0337.00 Hexetidine 141-94-6 100mg N N

Impurity A (EP): 2-Ethyl-N-[[1-(2-ethylhexyl)-4-methyl-4,5-


dihydro-1H-imidazol-4-yl]methyl]hexan-1-amine
N
H
N
MM0337.01 188655-38-1 100mg N

(Dehydrohexetidine)
Impurity C (EP): 2,6-Bis(2-ethylhexyl)-7a-methyl-
N
MM0337.03 hexahydro-1H-imidazo[1,5-c]imidazole 5980-31-4 100mg N N

(Hexedine)

Hexobarbital

O N O

MM1349.00 Hexobarbital 56-29-1 100mg NH

Hexylresorcinol
HO OH

MM0111.00 Hexylresorcinol 136-77-6 500mg

OH
MM0045.11 Impurity A (EP): Phenol 108-95-2 100mg

HO OH
MM0294.01-
Impurity B (EP): Resorcinol 108-46-3 250mg
0250

Histamine Dihydrochloride
N

MM3010.00 Histamine Dihydrochloride 56-92-8 250mg HN


N H2
HCl
2

Histamine Phosphate
N O OH

MM1666.00 Histamine Phosphate 51-74-1 250mg HN


NH2 HO
P
OH
2

Histapyrrodine

MM3102.01 Histapyrrodine Hydrochloride 6113-17-3 100mg N


N
HCl

Histidine
N NH2
HN
OH
MM1526.00 Histidine (L-Histidine) 71-00-1 250mg
O

Histidine Hydrochloride Monohydrate


N NH2 HCl
Histidine Hydrochloride Monohydrate (L-Histidine HN
OH
MM1567.00 5934-29-2 250mg H2O
Hydrochloride Monohydrate) O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-296
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Homatropine Hydrobromide
HBr
AND Enantiomer
H

Homatropine Hydrobromide
O
H
MM1649.00 51-56-9 100mg N
O
OH
H

AND Enantiomer
H
MM1649.02- O
H +
Homatropine N-Oxide Hydrochloride n/a 25mg O N HCl
O

0025 OH
H

Homatropine Hydrochloride
AND Enantiomer
H
O

Homatropine Hydrochloride
H
N
MM3214.00 637-21-8 100mg O
OH
H
HCl

Homatropine Methylbromide
AND Enantiomer
H Br

Homatropine Methylbromide
O
H +
MM0792.00 80-49-9 250mg N
O
OH
H

O
Impurity C (EP): (2RS)-2-Hydroxy-2-phenylacetic
MM0792.03
Acid (Mandelic Acid)
90-64-2 100mg OH
OH

Impurity D (EP) as Bromide: (1R,2R,4S,5S,7s)-7- H H


MM0792.04- [[(2S)-3-Hydroxy-2-phenylpropanoyl]oxy]-9,9- O
H
O
N
+
O Br

dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]-
155-41-9 250mg
OH H H
0250
nonane Bromide (Methylhyoscine Bromide)
O
Impurity F (EP): Methyl (2RS)-2-Hydroxy-2-
MM0792.06 4358-87-6 100mg O
phenylacetate (Methyl Mandelate)
OH

O
MM0792.06- Impurity F (EP): Methyl (2RS)-2-Hydroxy-2-
4358-87-6 25mg O
0025 phenylacetate (Methyl Mandelate)
OH

Homosalate

MM1570.00 Homosalate 118-56-9 250mg O

OH

Hydrochlorothiazide
O O O O
S S
MM0011.00- H 2N NH
Hydrochlorothiazide 58-93-5 250mg
0250 Cl N
H

O O O O
S S
MM0011.03 Impurity A (EP): Chlorothiazide 58-94-6 500mg H2 N NH

Cl N

Impurity B (EP): 4-Amino-6-chlorobenzene- O O O O


1,3-disulphonamide (Salamide) H 2N
S S
NH2
Related compound A (USP): 4-Amino-6-chloro-1,3-
MM0011.01 121-30-2 100mg
Cl N H2
benzenedisulfonamide
Impurity B (EP): 4-Amino-6-chlorobenzene- O O O O
MM0011.01- 1,3-disulphonamide (Salamide) H 2N
S S
NH2
Related compound A (USP): 4-Amino-6-chloro-1,3-
121-30-2 25mg
0025 Cl N H2
benzenedisulfonamide

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-297
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity C (EP): 6-Chloro-N-[(6-chloro-7-sulphamoyl-2,3- O O O O


S S
H2 N NH

MM0011.04- dihydro-4H-1,2,4-benzothiadiazin-4-yl 1,1-Dioxide)methyl]- Cl N O O O O


402824-96-8 25mg N
S S
NH
0025 H
3,4-dihydro-2H-1,2,4-benzothia-diazine-7-sulphonamide 1,1- Cl N
H

Dioxide
O O O O
S S
MM0011.05- H2 N NH
5-Chlorohydrochlorothiazide 5233-42-1 25mg Cl N
0025 H
Cl

O O O O
S S
MM0011.07- H2 N NH2
4-Amino-5,6-dichlorobenzene-1,3-disulfonamide 5250-72-6 25mg Cl NH2
0025
Cl

Hydrocodone Hydrogen Tartrate 2.5-Hydrate


OH O
N
HO
OH

MM1113.00 Hydrocodone Hydrogen Tartrate 2.5-Hydrate 34195-34-1 CS 100mg H


O OH
2

O O O H2O
2 5

Impurity A (EP) as Hydrochloride Trihydrate: H HCl H 2O


MM0037.00 6055-06-7 CS 250mg 3

Morphine Hydrochloride Trihydrate HO O OH

Impurity A (EP) as Hemisulphate Pentahemihydrate: H HO S O H


O
H2O
MM0280.00 5
6211-15-0 CS 250mg O

Morphine Hemisulphate Pentahemihydrate HO O OH


2

Impurity B (EP) as Hydrogen Tartrate: 4,5 -Epoxy-3- N


OH O
MM0812.00- H HO
OH
methoxy-17-methylmorphinan-6 -ol Hydrogen Tartrate 5965-13-9 CS 250mg O OH
0250 O O OH
(Dihydrocodeine Hydrogen Tartrate)
N

Impurity C (EP) as Monohydrate: Codeine H H2O


MM0004.00 6059-47-8 CS 100mg
Monohydrate
O O OH

Impurity C (EP) as Phosphate Hemihydrate: H


HO
P
OH

OH
H2O
MM0442.00 41444-62-6 CS 100mg O

Codeine Phosphate Hemihydrate O O OH


2
2

MM0672.00- Impurity D (EP) as Hydrochloride: 4,5 -Epoxy-14-


HO HCl
hydroxy-3-methoxy-17-methylmorphinan-6- 124-90-3 CS 250mg
one Hydrochloride (Oxycodone Hydrochloride)
0250
O O O

N
Impurity E (EP): 7,8-Didehydro-4,5 -epoxy-3-
H
MM0004.02 methoxy-17-methylmorphinan-6-one 467-13-0 100mg
(Codeinone)
O O O

MM0004.02- Impurity E (EP): 7,8-Didehydro-4,5 -epoxy-3-


H
methoxy-17-methylmorphinan-6-one 467-13-0 25mg
0025 (Codeinone)
O O O

N
Impurity F (EP): 7,8-Didehydro-4,5 -epoxy-
H
MM0004.03 3,6 -dimethoxy-17-methylmorphinan 2859-16-7 CS 100mg
(Methylcodeine; O-Methylcodeine) O
O O

MM0004.03- Impurity F (EP): 7,8-Didehydro-4,5 -epoxy-


H
3,6 -dimethoxy-17-methylmorphinan 2859-16-7 CS 25mg
0025
(Methylcodeine; O-Methylcodeine) O
O O

O
Impurity H (EP): Diphenylmethanone
MM0630.01 119-61-9 100mg
(Benzophenone)

O
MM0630.01- Impurity H (EP): Diphenylmethanone
119-61-9 25mg
0025 (Benzophenone)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-298
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N
Impurity K (EP) as Hydrochloride: 4,5 -Epoxy-3-hydroxy-17-
MM0371.00- H HCl
methylmorphinan-6-one Hydrochloride (Hydromorphone 71-68-1 CS 250mg
0250
Hydrochloride) HO O O

O +
N

H
MM1113.17 Hydrocodone N-Oxide 909265-05-0 100mg

O O O

O +
N

MM1113.17- H
Hydrocodone N-Oxide 909265-05-0 25mg
0025
O O O

Hydrocortisone
O
OH
HO OH
MM0185.00-
Hydrocortisone (Cortisol) 50-23-7 250mg H

0250 H H
O

O
OH
HO OH
MM0193.00-
Impurity A (EP): Prednisolone 50-24-8 250mg H

0250 H H
O

O
OH
Impurity B (EP): 17,21-Dihydroxypregn-4-ene- O
H
OH

MM0214.00 53-06-5 500mg


3,11,20-trione (Cortisone) H H
O

O
O

MM0187.00- Impurity C (EP): Hydrocortisone Acetate HO


H
OH
O

50-03-3 250mg
0250 (Hydrocortisone 21-Acetate) H H
O

Impurity D (EP): 6 ,11 ,17,21-Tetrahydroxy- HO OH


OH

H
MM0185.06 pregn-4-ene-3,20-dione 53-35-0 100mg H H

(6 -Hydroxyhydrocortisone) O
OH

Impurity D (EP): 6 ,11 ,17,21-Tetrahydroxy- HO OH


OH

MM0185.06- H
pregn-4-ene-3,20-dione 53-35-0 25mg H H
0025
(6 -Hydroxyhydrocortisone) O
OH

O
OH
Impurity E (EP): 11 ,17,21-Trihydroxypregna- HO
H
OH

MM0185.07 600-99-7 100mg


4,6-diene-3,20-dione ( -Hydrocortisone) H H
O

O
OH
MM0185.07- Impurity E (EP): 11 ,17,21-Trihydroxypregna- HO
H
OH

600-99-7 25mg
0025 4,6-diene-3,20-dione ( -Hydrocortisone) H H
O

O
OH
Impurity F (EP): 17,21-Dihydroxypregn-4- H
OH

MM0185.08 152-58-9 100mg


ene-3,20-dione (Reichstein's Substance S) H H
O

O
OH
MM0185.08- Impurity F (EP): 17,21-Dihydroxypregn-4- H
OH

152-58-9 25mg
0025 ene-3,20-dione (Reichstein's Substance S) H H
O

O
OH
HO O
MM0187.01- Impurity J (EP): 11 ,21-Dihydroxy-3,20-dioxopregn-4-en-17- H
16463-74-4 25mg O
0025 yl Acetate (Hydrocortisone 17-Acetate) H H
O

MM0185.27- Impurity K (EP): 17-Hydroxy-3,20-dioxopregn-4- O


O
OH
en-21-yl Acetate (Reichstein's Substance S 640-87-9 25mg H

0025 21-Acetate) O
H H

O
OH
MM0185.15- Impurity M (EP): 11 ,17,21-Trihydroxypregn-4- HO
H
OH

566-35-8 25mg
0025 ene-3,20-dione (Epihydrocortisone) H H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-299
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
OH
HO OH
H
MM0185.13 6 -Hydroxyhydrocortisone 2242-98-0 50mg H H
O
OH

O
OH
MM0185.35- 17,21-Dihydroxy-9 ,1 -epoxypregn-4-ene-3,20-dione OH
O
10072-97-6 25mg
0025 (9 ,11 -Epoxyhydrocortisone) H H
O

Hydrocortisone Acetate
O
O
O
MM0187.00- HO OH
Hydrocortisone Acetate 50-03-3 250mg H

0250 H H
O

O
OH
MM0185.00- Impurity A (EP): 11 ,17,21-Trihydroxypregn-4-ene-3,20- HO
H
OH

50-23-7 250mg
0250 dione (Hydrocortisone) H H
O

O
O

MM0194.00- Impurity C (EP): 11 ,17-Dihydroxy-3,20-dioxopregna-1,4- HO


H
OH
O

52-21-1 250mg
0250 dien-21-yl Acetate (Prednisolone Acetate) H H
O

O
O

MM0186.00- Impurity D (EP): 17-Hydroxy-3,11,20-trioxopregn-4-en-21-yl O


H
OH
O

50-04-4 250mg
0250 Acetate (Cortisone Acetate) H H
O

O
OH
HO O
MM0187.01-
Hydrocortisone 17-Acetate 16463-74-4 25mg H
O
0025 H H
O

O
O O
O
MM0187.06- O O
Hydrocortisone 11,17,21-Triacetate 3517-51-9 25mg H
O
0025 H H
O

O
O
O
11 ,17,21-Trihydroxypregna-4,6-diene- HO
H
OH
MM0187.09 21940-45-4 100mg
3,20-dione 21-Acetate H H
O

O
O
O
MM0187.09- 11 ,17,21-Trihydroxypregna-4,6-diene- HO
H
OH
21940-45-4 25mg
0025 3,20-dione 21-Acetate H H
O

Hydrocortisone Butyrate
O
OH
HO O

MM0188.00 Hydrocortisone 17-Butyrate 13609-67-1 500mg H


O
H H
O

O
O
O
HO OH

MM0188.01 Hydrocortisone 21-Butyrate 6677-99-2 100mg H

H H
O

O
O
O
MM0188.01- HO OH

Hydrocortisone 21-Butyrate 6677-99-2 25mg H

0025 H H
O

Hydrocortisone 17-Butyrate 21-Propionate


O
O
O
MM0189.00- HO O
Hydrocortisone 17-Butyrate 21-Propionate 72590-77-3 250mg H
O
0250 H H
O

Hydrocortisone Hydrogen Succinate


O
O
OH
O
HO

Hydrocortisone Hydrogen Succinate


OH O
H
MM0275.00 2203-97-6 250mg H H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-300
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
OH
HO OH
MM0185.00-
Impurity A (EP): Hydrocortisone 50-23-7 250mg H

0250 H H
O

O
O
O
MM0187.00- HO OH
Impurity B (EP): Hydrocortisone Acetate 50-03-3 250mg H

0250 H H
O

Hydrocortisone Sodium Succinate


O
O +
O Na
O
HO

Hydrocortisone Sodium Succinate


OH O
H
MM3100.00 125-04-2 250mg H H
O

Hydrocortisone Sodium Sulfobenzoate


O O O
O +
S Na
O O
HO

Hydrocortisone Sodium Sulfobenzoate


OH
H
MM0949.00 33767-03-2 100mg H H
O

Hydroflumethiazide
O O O O
S S
H 2N NH
MM3099.00 Hydroflumethiazide 135-09-1 100mg F
N
H
F F

Hydromorphone Hydrochloride
N

MM0371.00-
Hydromorphone Hydrochloride 71-68-1 CS 250mg H HCl

0250
HO O O

O +
Impurity B (EP) as Hydrochloride: 4,5 -Epoxy-3-hydroxy-17- N

MM0371.09 methylmorphinan-6-one 17-Oxide Hydrochloride n/a 100mg H


HCl

(Hydromorphone N-Oxide Hydrochloride) HO O O

Impurity C (EP) as Hydrochloride Trihydrate: H HCl H 2O


MM0037.00 6055-06-7 CS 250mg 3

Morphine Hydrochloride Trihydrate HO O OH

Impurity C (EP) as Hemisulphate Pentahemi- N


O

MM0280.00 hydrate: Morphine Hemisulphate Pentahemi- 6211-15-0 CS 250mg H HO S O H


O
H2O
5

hydrate HO O OH
2

Impurity D (EP): 4,5 -Epoxy-17-methylmorphinan-3,6 -diol H


MM1369.01 509-60-4 CS 100mg
(Dihydromorphine)
HO O OH

7,8-Didehydro-4,5 -epoxy-3-hydroxy-17-methylmorphinan-6- N

MM0037.23- one (Morphinone) H


467-02-7 25mg
0025 Related compound A (USP): 7,8-didehydro-4,5alpha-epoxy-
3-hydroxy-17-methylmorphinan-6-one perchlorate HO O O

N
HCl

HO
MM0272.00 Naloxone Hydrochloride Dihydrate 51481-60-8 250mg H2O
2

HO O O

Hydroquinidine Hydrochloride
H
H

MM3098.00 Hydroquinidine Hydrochloride 1476-98-8 100mg O


HO
H
HCl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-301
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Hydroxycarbamide (Hydroxyurea)
O
MM0895.00-
Hydroxycarbamide 127-07-1 250mg OH
0250 H 2N N
H

O O
MM0895.05-
3-Hydroxybiuret 4381-13-9 25mg H2 N N NH2
0025 OH

Hydroxychloroquine Sulphate
O O
Cl N S
HO OH
MM0764.00-
Hydroxychloroquine Sulphate 747-36-4 250mg HN
N
OH
0250

Impurity A (EP) as Dihydrochloride: 4-[(7-Chloroquinolin-4-yl)


Cl N
HCl
amino]-N-ethyl-N-(hydroxyethyl)pentan-1-amine N-Oxide 2

MM0764.05 n/a 10mg HN + OH


N
O
Dihydrochloride (Hydroxychloroquine N-Oxide
Dihydrochloride)

Impurity C (EP) as Dihydrochloride: 2-[[4-[(7-Chloroquinolin- Cl N


HCl
2
MM0764.02 4-yl)amino]pentyl]amino]ethan-1-ol Dihydrochloride n/a 100mg HN
N
OH
H

(Desethylhydroxychloroquine Dihydrochloride)

Impurity C (EP) as Dihydrochloride: 2-[[4-[(7-Chloroquinolin- Cl N


HCl
MM0764.02- 2
4-yl)amino]pentyl]amino]ethan-1-ol Dihydrochloride n/a 25mg HN
N
OH
0025 H

(Desethylhydroxychloroquine Dihydrochloride)
Cl N

MM0617.03 Impurity G (EP): 4,7-Dichloroquinoline 86-98-6 100mg


Cl

Cl N
MM0617.03-
Impurity G (EP): 4,7-Dichloroquinoline 86-98-6 25mg
0025
Cl
Cl N

MM0764.04 O-Acetylhydroxychloroquine 47493-14-1 100mg HN


N
O

Hydroxyethyl Salicylate
O
MM0112.00- OH
Hydroxyethyl Salicylate 87-28-5 100mg O
0100 OH

O
MM0045.00- OH
Impurity A (EP): Salicylic Acid 69-72-7 250mg
0250
OH

OH
MM0112.02 Impurity B (EP): Ethane-1,2-diol (Ethylene Glycol) 107-21-1 100mg HO

Hydroxyphenamate
HO
O NH2
MM3109.00 Hydroxyphenamate 50-19-1 100mg
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-302
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Hydroxyprogesterone Caproate
O O

MM1548.00- O

Hydroxyprogesterone Caproate 630-56-8 250mg H


H

H
0250 O

Hydroxyurea, see Hydroxycarbamide

Hydroxyzine Hydrochloride
Cl O
N OH
N

MM0852.00 Hydroxyzine Hydrochloride 2192-20-3 250mg HCl


2

Cl
Impurity A (EP): (RS)-1-[(4-Chlorophenyl)- NH
N
phenylmethyl]piperazine
MM0380.01
Related compound A (USP): 1-[(4-Chlorophenyl)
303-26-4 100mg
phenylmethyl]piperazine
Cl
Impurity A (EP): (RS)-1-[(4-Chlorophenyl)- NH
N
MM0380.01- phenylmethyl]piperazine
303-26-4 25mg
0025 Related compound A (USP): 1-[(4-Chlorophenyl)
phenylmethyl]piperazine
Impurity B (EP) as Dihydrochloride: 2-[2-[4- O
N OH

MM0852.02- (Diphenylmethyl)piperazin-1-yl]ethoxy]- N
HCl
13073-96-6 25mg 2

0025 ethanol Dihydrochloride (Decloxizine


Dihydrochloride)
MM0852.05- HO Cl
2-(2-Chloroethoxy)ethanol 628-89-7 100mg O
0100
O
N OH
MM1130.19 2-[2-(Piperazin-1-yl)ethoxy]ethanol 13349-82-1 100mg HN

MM0380.10 4-Chlorobenzophenone 134-85-0 100mg


O

Cl

MM0380.10-
4-Chlorobenzophenone 134-85-0 25mg
0025 O

Cl

Hydroxyzine Pamoate
Cl O
N OH O OH HO O

Hydroxyzine Pamoate
N HO OH

MM3107.00 10246-75-0 250mg

Hymecromone
HO O O

MM0294.00 Hymecromone 90-33-5 500mg

HO OH
MM0294.01- Impurity A (EP): 1,3-Dihydroxybenzene
108-46-3 250mg
0250 (Resorcinol)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-303
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HO O
Impurity B (EP): 7-Hydroxy-2-methyl-4H-1-
MM0294.02 6320-42-9 100mg
benzopyran-4-one
O

HO O
MM0294.02- Impurity B (EP): 7-Hydroxy-2-methyl-4H-1-
6320-42-9 25mg
0025 benzopyran-4-one
O

HO OH
MM0294.03-
2,4-Dihydroxyacetophenone 89-84-9 25mg O
0025

O O O
MM0294.04-
Hymecromone Acetate 2747-05-9 25mg O
0025
O O
MM0294.50- 7-Acetoxy-3-acetyl-2-4H-1-benzopyran- O
52751-48-1 25mg
0025 4-one O O

Hyoscine Butylbromide
H H
O
MM0683.00- H +
Br

Hyoscine Butylbromide
N O
O
149-64-4 250mg OH H H
0250
H

Impurity A (EP) as Hydrobromide Trihydrate:


H
O HBr
H
N O
O
MM0546.00 6533-68-2 500mg
Hyoscine Hydrobromide Trihydrate
H2 O
H 3
OH H

O
Impurity B (EP): (2RS)-3-Hydroxy-2-phenylpropanoic
MM0601.03 552-63-6 100mg OH
Acid (DL-Tropic Acid; Tropic Acid)
OH

O
MM0601.03- Impurity B (EP): (2RS)-3-Hydroxy-2-phenylpropanoic
552-63-6 25mg OH
0025 Acid (DL-Tropic Acid; Tropic Acid)
OH

Impurity E (EP) as Hydrochloride: (1R,2R,4S,5S,7s)-9-Butyl-


H H
O
MM0683.05- 3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl (2S)-3-Hydroxy-2- H
O
N O HCl

22235-98-9 25mg OH H H
0025 phenylpropanoate Hydrochloride (N-Butylnorhyoscine
Hydrochloride)
Impurity G (EP) as Bromide: (1R,2R,4S,5S,7s,9r)-9-Butyl-9-
H H
O
H +
MM0683.07- methyl-7-[(2-phenylprop-2-enoyl)oxy]-3-oxa-9-azatricyclo O
N O Br

92714-23-3 25mg H H
0025 [3.3.1.02,4]nonan-9-ium Bromide (Apo-N-Butylhyoscine
Bromide; Apohyoscine Butylbromide)
H H

H +
MM0683.06- N O Br
HO
N-Butylscopine Bromide 2030294-83-6 25mg
0025 H H

AND Enantiomer

MM0683.09- (1s,3RS,4RS,5RS,7SR)-4-Hydroxy-6-butyl-6-methyl-2-oxa-6- H
+

azoniatricyclo[3.3.1.03,7]nonane Bromide
n/a 25mg N
0025 H H Br
O
H OH

Hyoscine Hydrobromide (Scopolamine Hydrobromide)


H H
O HBr
H

MM0546.00 Hyoscine Hydrobromide Trihydrate 6533-68-2 500mg O


N

H
O
H2 O
3
OH H

H
O
H
MM1699.00 Impurity A (EP): Hyoscyamine 101-31-5 100mg O
N

OH H

Impurity C (EP): (1R,2R,4S,5S,7s)-9-Methyl-3-oxa- O


H H

H
MM0546.06 9-azatricyclo[3.3.1.02,4]non-7-yl 2-Phenylprop- 535-26-2 100mg O
N O

H
2-enoate (Apohyoscine) H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-304
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0546.06- Impurity C (EP): (1R,2R,4S,5S,7s)-9-Methyl-3-oxa- O


H H

H
9-azatricyclo[3.3.1.02,4]non-7-yl 2-Phenylprop- 535-26-2 25mg O
N O

H
0025 2-enoate (Apohyoscine) H

O
Impurity D (EP): (2RS)-3-Hydroxy-2-phenylpropanoic
MM0601.03 552-63-6 100mg OH
Acid (DL-Tropic Acid; Tropic Acid)
OH

O
MM0601.03- Impurity D (EP): (2RS)-3-Hydroxy-2-phenylpropanoic
552-63-6 25mg OH
0025 Acid (DL-Tropic Acid; Tropic Acid)
OH

H H
O
H

Hyoscine N-Oxide Hydrobromide


+
N O HBr
MM0546.07 6106-81-6 100mg O O

H
OH H

H H
O
MM0546.07- H

Hyoscine N-Oxide Hydrobromide


+
N O HBr
6106-81-6 25mg O O

H
0025 OH H

AND Enantiomer
H H

H
MM0546.09 Scopine 498-45-3 100mg N O
HO

H H

AND Enantiomer
H H
MM0546.09- H
Scopine 498-45-3 25mg N O
HO
0025 H H

AND Enantiomer
H H

H
MM0546.11 Scopine Hydrochloride 85700-55-6 100mg N O HCl
HO

H H

AND Enantiomer
H H
MM0546.11- H
Scopine Hydrochloride 85700-55-6 25mg N O HCl
HO
0025 H H

Hyoscyamine
H
O
H
MM1699.00 Hyoscyamine 101-31-5 100mg O
N

OH H

Hyoscyamine Sulfate
H
O
H
N
MM1699.00 Hyoscyamine 101-31-5 100mg O

OH H

O
Impurity A (EP): (2RS)-3-Hydroxy-2-
MM0601.03 phenylpropanoic Acid (DL-Tropic Acid; 552-63-6 100mg OH
Tropic Acid)
OH

O
MM0601.03- Impurity A (EP): (2RS)-3-Hydroxy-2-
phenylpropanoic Acid (DL-Tropic Acid; 552-63-6 25mg OH
0025 Tropic Acid)
OH

Impurity D (EP) as Hydrobromide Trihydrate:


H
O HBr
H
N O
O
MM0546.00 6533-68-2 500mg
Hyoscine Hydrobromide Trihydrate
H2 O
H 3
OH H

Impurity G (EP) as Hydrochloride: (1R,3r,5S)-8-Methyl- O


H

H
MM0289.01 8-azabicyclo[3.2.1]oct-3-yl 2-Phenylprop-2-enoate 5978-81-4 100mg O
N HCl

Hydrochloride (Apoatropine Hydrochloride) H

MM0289.01- Impurity G (EP) as Hydrochloride: (1R,3r,5S)-8-Methyl- O


H

8-azabicyclo[3.2.1]oct-3-yl 2-Phenylprop-2-enoate 5978-81-4 25mg O


N HCl

0025 Hydrochloride (Apoatropine Hydrochloride) H

H
O
MM0794.09- H
O N
+
HCl
Hyoscyamine N-Oxide Hydrochloride 200721-88-6 25mg O

0025 OH H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-305
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Ibandronate Sodium Monohydrate


OH
O OH
MM1326.00- HO P

Ibandronate Sodium Monohydrate 138926-19-9 250mg N


OH
P O
Na
+
H2 O

O
0250

3-[Methyl(pentyl)amino]propanoic Acid Hydrochloride O


MM1326.01- HCl
Related compound A (USP): 3-[Methyl(pentyl)amino] 625120-81-2 25mg N OH

0025
propanoic acid

MM1326.03- N
3-[N-Methyl(pentyl)amino]propanenitrile 919491-64-8 100mg N
0100
OH
O OH
MM1326.06- HO P
OH
N-Desmethylibandronate Sodium 953805-81-7 25mg N
H
P O
Na
+

0025 O

H
MM1326.10- N
3-(Methylamino)propanenitrile 693-05-0 100mg
0100 N

Ibogaine Hydrochloride
N
O H
MM1901.00 Ibogaine Hydrochloride 5934-55-4 100mg N
H
HCl

Ibrutinib

NH2

MM3746.00 Ibrutinib 936563-96-1 250mg N


N
N N

Ibufenac
OH

MM1872.00 Ibufenac 1553-60-2 50mg O

MM1872.01 Ibufenac Methyl Ester 61566-33-4 100mg O

MM1872.02 Ibufenac Ethyl Ester 15649-02-2 100mg O

MM1872.03 Ibufenac Isopropyl Ester n/a 100mg O

Ibuprofen
OH
MM0002.00 Ibuprofen 15687-27-1 500mg
O

Impurity A (EP): (2RS)-2-[3-(2-Methylpropyl)- OH


MM0002.13 66622-47-7 100mg
phenyl]propanoic Acid O

Impurity B (EP): (2RS)-2-(4-Butylphenyl)- OH


MM0002.01 3585-49-7 100mg
propanoic Acid O

Impurity C (EP): (2RS)-2-[4-(2-Methylpropyl)- N H2


MM0002.10 59512-17-3 100mg
phenyl]propanamide O

MM0002.10- Impurity C (EP): (2RS)-2-[4-(2-Methylpropyl)- N H2


59512-17-3 25mg
0025 phenyl]propanamide O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-306
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity D (EP): (2RS)-2-(4-Methylphenyl)- OH


MM0002.11 938-94-3 100mg
propanoic Acid O

MM0002.11- Impurity D (EP): (2RS)-2-(4-Methylphenyl)- OH


938-94-3 25mg
0025 propanoic Acid O

O
Impurity E (EP): 1-[4-(2-Methylpropyl)phenyl]-
MM0002.04 ethanone 38861-78-8 100mg
Related compound C (USP): 4-isobutylacetophenone
O
Impurity F (EP): 3-[4-(2-Methylpropyl)phenyl]- OH
MM0002.28 65322-85-2 100mg
propanoic Acid
O
MM0002.28- Impurity F (EP): 3-[4-(2-Methylpropyl)phenyl]- OH
65322-85-2 25mg
0025 propanoic Acid
AND Enantiomer
O OH

Impurity G (EP): (1RS,4RS)-7-(2-Methylpropyl)-1-


MM0002.38 [4-(2-methylpropyl)phenyl]-1,2,3,4-tetrahydro- 2575516-43-5 50mg OH

naphthalene-1,4-dicarboxylic Acid O

Impurity H (EP): (3RS)-1,3-Bis[4-(2-methyl- O

MM0002.30 2143535-25-3 100mg


propyl)phenyl]butan-1-one
Impurity I (EP): 1-(2-Methylpropyl)-4-[(3RS)-3-
MM0002.31 2143535-26-4 50mg
[4-(2-methylpropyl)phenyl]butyl]benzene
Impurity J (EP): (2RS)-2-[4-(2-Methyl-
OH
propanoyl)phenyl]propanoic Acid
O
Related compound J (USP): 2-(4-Isobutyrylphenyl)
MM0002.02 65813-55-0 100mg
O
propanoic acid
Impurity J (EP): (2RS)-2-[4-(2-Methyl-
OH
MM0002.02- propanoyl)phenyl]propanoic Acid
O
Related compound J (USP): 2-(4-Isobutyrylphenyl)
65813-55-0 25mg
0025
O
propanoic acid

Impurity K (EP): (2RS)-2-(4-Formylphenyl)- OH


MM0002.26 43153-07-7 100mg
propanoic Acid O O

MM0002.26- Impurity K (EP): (2RS)-2-(4-Formylphenyl)- OH


43153-07-7 25mg
0025 propanoic Acid O O

Impurity L (EP): 2-[4-(1-Hydroxy-2- OH

MM0002.24 methylpropyl)phenyl]propanoic Acid 53949-53-4 100mg O

(1-Hydroxyibuprofen) OH

MM0002.24- Impurity L (EP): 2-[4-(1-Hydroxy-2- OH

methylpropyl)phenyl]propanoic Acid 53949-53-4 25mg O


0025 (1-Hydroxyibuprofen) OH

HO
Impurity M (EP): (2RS)-2-Hydroxy-2-[4-(2- OH
MM0002.34 60057-62-7 100mg
methylpropyl)phenyl]propanoic Acid O

HO
MM0002.34- Impurity M (EP): (2RS)-2-Hydroxy-2-[4-(2- OH
60057-62-7 25mg
0025 methylpropyl)phenyl]propanoic Acid O

Impurity N (EP): (2RS)-2-(4-Ethylphenyl)- OH


MM0002.35 3585-52-2 100mg
propanoic Acid O

MM0002.35- Impurity N (EP): (2RS)-2-(4-Ethylphenyl)- OH


3585-52-2 25mg
0025 propanoic Acid O

OH
Impurity O (EP): 2-[4-(1-Methylpropyl)-
MM0002.33 64451-76-9 100mg O
phenyl]propanoic Acid

OH
MM0002.33- Impurity O (EP): 2-[4-(1-Methylpropyl)-
64451-76-9 25mg O
0025 phenyl]propanoic Acid

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-307
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity P (EP): (2RS)-2-[4-(2-Methylpropyl)- OH


MM0002.19 36039-36-8 100mg
phenyl]propan-1-ol

Impurity Q (EP): 2-[4-(2-Methylpropyl)phenyl]- OH

MM0002.36 36039-35-7 100mg


ethanol
Impurity R (EP): 1,1'-(Ethane-1,1-diyl)-4,4'-(2-
MM0002.37 102120-87-6 100mg
methylpropyl)dibenzene
O

MM0002.03 4-Isobutylbenzoic Acid 38861-88-0 100mg OH

O
MM0002.03-
4-Isobutylbenzoic Acid 38861-88-0 25mg OH
0025

N H2

MM0002.07 2-(4-Isobutyrylphenyl)propanamide 1823308-53-7 100mg O

N H2
MM0002.07-
2-(4-Isobutyrylphenyl)propanamide 1823308-53-7 25mg O
0025 O

OH
MM0002.08 4-Acetylbenzoic Acid 586-89-0 100mg
O

MM0002.08- OH
4-Acetylbenzoic Acid 586-89-0 25mg
0025
O

MM0002.09 4-Isobutyrylacetophenone 103931-20-0 100mg


O

MM0002.09-
4-Isobutyrylacetophenone 103931-20-0 25mg
0025
O

MM0002.14 2-(4-Isobutyrylphenyl)propane 72846-62-9 100mg


O

OH
2-Hydroxypropyl 2-(4-Isobutylphenyl)- O

propanoate
MM0002.15 95093-58-6 100mg O

OH
2,3-Dihydroxypropyl 2-(4- O OH

Isobutylphenyl)propanoate
MM0002.17 64622-21-5 50mg O

OH
MM0002.20 2-(4-n-Propylphenyl)propanoic Acid 3585-47-5 100mg
O

MM0002.20- OH
2-(4-n-Propylphenyl)propanoic Acid 3585-47-5 25mg
0025 O

MM0002.21 2-(4-Isobutylphenyl)propionitrile 58609-73-7 100mg N

O
MM0002.23 Isopropyl 2-(4-Isobutylphenyl)propanoate 64622-17-9 100mg O

MM0002.25 1-Ethyl-4-isobutylbenzene 100319-40-2 100mg

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-308
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

AND Enantiomer
O OH

(1RS,4SR)-7-(2-Methylpropyl)-1-[4-(2-methyl-
MM0002.29 propyl)phenyl]-1,2,3,4-tetrahydronaphthalene- 2517611-89-9 100mg OH

1,4-dicarboxylic Acid O

AND Enantiomer
O OH

MM0002.29- (1RS,4SR)-7-(2-Methylpropyl)-1-[4-(2-methyl-
propyl)phenyl]-1,2,3,4-tetrahydronaphthalene- 2517611-89-9 25mg OH
0025 1,4-dicarboxylic Acid O

2-[4-(2-Hydroxy-2-methylpropyl)- OH
MM0002.32 phenyl]propanoic Acid (2-Hydroxy- 51146-55-5 100mg O
ibuprofen) HO

MM0002.32- 2-[4-(2-Hydroxy-2-methylpropyl)- OH
phenyl]propanoic Acid (2-Hydroxy- 51146-55-5 25mg O
0025 ibuprofen) HO

MM0002.41- H
N
N-( -Phenylethyl)ibuprofenamide 105959-56-6 25mg O
0025
AND Enantiomer
(2SR)-2-(4-Isobutylphenyl)-N-((SR)-1- 121734-80-3 and H
N
MM0002.45 100mg
phenylethyl)propanamide 81576-52-5 O

AND Enantiomer
MM0002.45- (2SR)-2-(4-Isobutylphenyl)-N-((SR)-1- 121734-80-3 and H
N
25mg
0025 phenylethyl)propanamide 81576-52-5 O

AND Enantiomer
(2SR)-2-(4-Isobutylphenyl)-N-((RS)-1- 121734-79-0 and H
N
MM0002.46 100mg
phenylethyl)propanamide 81576-47-8 O

AND Enantiomer
MM0002.46- (2SR)-2-(4-Isobutylphenyl)-N-((RS)-1- 121734-79-0 and H
N
25mg
0025 phenylethyl)propanamide 81576-47-8 O

MM0002.48 4-Isobutylstyrene 63444-56-4 10mg

MM0002.49- O
(2RS)-2-[4-(2-Methylpropyl)phenyl]propan-1-al 51407-46-6 100mg
0100

MM0002.50 1-(4-Isobutylphenyl)ethanol 40150-92-3 100mg OH

4-(1-Hydroxy-2-methylpropyl)-
MM0002.51
acetophenone
1314907-71-5 100mg
OH

O
MM0002.53 Ibuprofen Methyl Ester 61566-34-5 100mg O

O
MM0002.56 Ibuprofen Ethyl Ester 41283-72-1 100mg O

1-(4-Isopropylphenyl)ethanone
MM0002.57 645-13-6 100mg
(4-Isopropylacetophenone)

OH
MM0002.59-
2-(4-Isopropylphenyl)acrylic Acid 1368714-46-8 25mg O
0025

MM0002.61- OH
2-(4-Isobutylphenyl)prop-2-enoic Acid 6448-14-2 25mg
0025 O

O OH
Ibuprofen 1,3-Butylene Glycol Esters (Mixture of Regio- and
MM0002.62 n/a 100mg
Stereoisomers) O OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-309
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
O
MM0002.63 Ibuprofen 2,3-Butylene Glycol Ester 95093-59-7 100mg O

OH
O

O
Ibuprofen 1,2-Propylene Glycol Esters (Mixture of Regio- and
MM0002.64 n/a 100mg
Stereoisomers) O
OH
O

OH
O OH

O
Ibuprofen 1,2,3-Propanetriol Esters (Mixture of Regio- and
MM0002.65 n/a 100mg
Stereoisomers) O
OH
O
OH

MM0002.66- OH
2-[4-(2-Methylpropenyl)phenyl]propionic Acid 75625-99-9 25mg O
0025

MM0002.74- H 2N HCl
-Phenylethylamine Hydrochloride 13437-79-1 25mg
0025
O

MM0002.75- O
Isopropyl 4-Acetylbenzoate 220089-22-5 100mg
0100
O

Icaridin
O

MM3755.00 Icaridin (Picaridin) 119515-38-7 250mg N O

OH

Idoxuridine
H
O N O

N
MM0791.00 Idoxuridine 54-42-2 500mg O
I

HO
HO

Ifosfamide
Cl
O
O
MM0292.00 Ifosfamide 3778-73-2 250mg P N
H
N
Cl

MM0292.08- Impurity E (EP) as Hydrochloride: 3-Chloro-N-(2-chloroethyl) Cl HCl


Cl N
78218-47-0 25mg H
0025 propan-1-amine Hydrochloride
Cl
Impurity G (Pharmeuropa): (2RS)-3-(Chloroacetyl)-2-[(2- O
O
MM0292.07- chloroethyl)amino]-1,3,2 5-oxazaphosphinan-2-one (3- P N
119670-13-2 25mg H
0025 (Chloroacetyl)-N-(2-chloroethyl)tetrahydro-2H-1,3,2- N
Cl
oxazaphosphorin-2-amine 2-Oxide) O

Ilaprazole
MM3745.01- O
Cl HCl
2-(Chloromethyl)-4-methoxy-3-methylpyridine Hydrochloride 86604-74-2 25mg N
0025

Iloperidone
F

HN
HCl
MM3659.01 (2,5-Difluorophenyl)-(4-piperidyl)methanone Hydrochloride 1172297-96-9 100mg
O F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-310
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM3659.01- HN
HCl
(2,5-Difluorophenyl)-(4-piperidyl)methanone Hydrochloride 1172297-96-9 25mg
0025
O F

O
O
MM3659.02 1-(4-Hydroxy-3-methoxyphenyl)propan-1-one 1835-14-9 100mg
OH

O
MM3659.02- O
1-(4-Hydroxy-3-methoxyphenyl)propan-1-one 1835-14-9 25mg
0025 OH

HN
MM3659.08- OH
1,2,3,6-Tetrahydropyridine-4-carboxylic Acid (Isoguvacine) 64603-90-3 25mg
0025
O

MM3659.05 1-(2-Hydroxy-3-methoxyphenyl)ethanone 703-98-0 100mg OH

MM3659.05-
1-(2-Hydroxy-3-methoxyphenyl)ethanone 703-98-0 25mg OH
0025
O

Imatinib
N
H H
N N N N N

MM1196.00 Imatinib 152459-95-5 100mg O N

Imatinib Mesilate
N

Imatinib Mesilate
H H O O
N N N N N
S
OH
MM3566.00 220127-57-1 250mg O N

N
H H
N N N N N

MM1196.00 Imatinib 152459-95-5 100mg O N

O
Impurity A (EP): (2E)-3-(Dimethylamino)-1-(pyridin-3-yl)prop- N N
MM3566.03 123367-26-0 100mg
2-en-1-one
O
MM3566.03- Impurity A (EP): (2E)-3-(Dimethylamino)-1-(pyridin-3-yl)prop- N N
123367-26-0 25mg
0025 2-en-1-one

N
MM3566.13- Impurity B (EP): N-(3-Carbamimidamido-4-methylphenyl)-4- N
H
N
H
N N H2
581076-65-5 25mg O NH
0025 [(4-methylpiperazin-1-yl)methyl]benzamide

Impurity F (EP): 4-Methyl-N3-[4-(pyridin-3-yl)pyrimidin-2-yl] H 2N


H
N N N
MM3566.06 152460-10-1 100mg
benzene-1,3-diamine N

MM3566.06- Impurity F (EP): 4-Methyl-N3-[4-(pyridin-3-yl)pyrimidin-2-yl] H 2N


H
N N N
152460-10-1 25mg
0025 benzene-1,3-diamine N

HN
MM1265.01 Impurity G (Pharmeuropa): 1-Methylpiperazine 109-01-3 100mg
N

Impurity H (EP): 1-(Pyridin-3-yl)ethan-1-one (3-


MM3566.05 350-03-8 100mg
Acetylpyridine)
N

H
MM0056.06 N-Methylmethanamine Hydrochloride 506-59-2 100mg N HCl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-311
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
2-Methyl-5-nitro-N-[4-(pyridin-3-yl)pyrimidin-2-yl] +
H
N N N N
MM3566.04 152460-09-8 100mg O
N
benzenamine
O
MM3566.04- 2-Methyl-5-nitro-N-[4-(pyridin-3-yl)pyrimidin-2-yl] +
H
N N N N
152460-09-8 25mg O
N
0025 benzenamine
N
N O
MM3566.07 Methyl 4-[(4-Methylpiperazin-1-yl)methyl]benzoate 314268-40-1 100mg
O

N
MM3566.07- N O
Methyl 4-[(4-Methylpiperazin-1-yl)methyl]benzoate 314268-40-1 25mg
0025 O

Cl
MM3566.08- 4-(Chloromethyl)-N-[4-methyl-3-[[4-(pyridin-3-yl)pyrimidin-2- H
N
H
N N N
404844-11-7 25mg O N
0025 yl]amino]phenyl]benzamide

MM3566.09- N
4-[(4-Formyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3- O N
H
N
H
N N N

1436868-85-7 25mg O N

0025 pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide

O
MM3566.12- 4-Formyl-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino] H
N
H
N N N
1219828-35-9 25mg O N
0025 phenyl]benzamide

N
MM3566.14- 4-[(4-Methylpiperazin-1-yl)methyl]benzoic Acid N OH
HCl
2
106261-49-8 25mg O
0025 Dihydrochloride

MM3566.15- N
3-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3- N
H
N
H
N N N

1246819-59-9 25mg O N

0025 pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide

NH O
MM3566.16- O + N
+
1-(2-Methyl-5-nitrophenyl)guanidine Nitrate 152460-08-7 25mg N N N H2 HO O
H
O
0025

H
MM3566.17- 4-[(4-Methyl-1-piperazinyl)methyl]-N-[3-methyl-4-[[4-(3- N N N
O
N
1026753-54-7 25mg N
N
N
H

0025 pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide
O
+
O N
MM3566.19- N

N-(2-Methyl-4-nitrophenyl)-4-(3-pyridinyl)-2-pyrimidinamine 796738-71-1 25mg N


0025 N
H
N

N O
MM3566.21- +
N
+ H H
O N N N N N
e Imatinib N1,N4-Dioxide 571186-93-1 25mg O N

w
0025

MM3566.25- N
4-[(4-Acetyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3- N
H
N
H
N N N

1321600-77-4 25mg O O N

0025 pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide
O
MM3566.26- N
N-[3-[Acetyl[4-(3-pyridinyl)-2-pyrimidinyl]amino]-4- N
H
N N N N
1321600-78-5 25mg O N

0025 methylphenyl]-4-[(4-methyl-1-piperazinyl)methyl]benzamide

MM3566.28- 4-Methyl-N-[4-methyl-3-[[4-(pyridin-3-yl)pyrimidin-2-yl]amino] H H
N N N N
152459-96-6 25mg O N
0025 phenyl]benzamide
N
H H
MM3566.32- N-[[(5-Amino-2-methylphenyl)amino]iminomethyl]-4-[(4- N N N

2753049-11-3 25mg O NH

0025 methyl-1-piperazinyl)methyl]benzamide NH2

N H2
MM0563.02 2-Methylbenzenamine (o-Toluidine) 95-53-4 100mg

Imipramine Hydrochloride

MM0077.00- N N HCl
Imipramine Hydrochloride 113-52-0 250mg
0250

Impurity A (EP) as Hydrochloride: 3-(10,11-Dihydro- HCl


N N
MM0589.00 5H-dibenzo[b,f]azepin-5-yl)-N-methylpropan-1- 58-28-6 250mg H

amine Hydrochloride (Desipramine Hydrochloride)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-312
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity B (EP): 3-(5H-Dibenzo[b,f]azepin-5-yl)-


N N
MM0077.05 N,N-dimethylpropan-1-amine (Depramine; 303-54-8 100mg
10,11-Dehydroimipramine)

Impurity B (EP): 3-(5H-Dibenzo[b,f]azepin-5-yl)-


MM0077.05- N N
N,N-dimethylpropan-1-amine (Depramine; 303-54-8 25mg
0025 10,11-Dehydroimipramine)

Impurity C (EP) as Hydrochloride: 10-[3-(Dimethyl- N N HCl


MM0077.08 2307-88-2 100mg
amino)propyl]acridin-9(10H)-one Hydrochloride O

MM0077.08- Impurity C (EP) as Hydrochloride: 10-[3-(Dimethyl- N N HCl


2307-88-2 25mg
0025 amino)propyl]acridin-9(10H)-one Hydrochloride O

MM0077.03- N-[3-(10,11-Dihydro-5H-dibenzo-[b,f]azepin-5- HCl


2

yl)propyl]-N,N',N'-trimethylpropane-1,3-diamine 1838-02-4 25mg N N N

0025 Dihydrochloride

N N
MM0077.04 10-Hydroxyimipramine BH3-Aduct 20438-96-4 100mg BH 3

HO

MM0077.04- N N
10-Hydroxyimipramine BH3-Aduct 20438-96-4 25mg BH 3

0025 HO

NH
MM0076.06 Iminodibenzyl 494-19-9 100mg

MM0076.06- NH
Iminodibenzyl 494-19-9 25mg
0025

+
N N
MM0077.12 Imipramine N-Oxide 6829-98-7 100mg O

MM0077.13- N-Acetyl-10,11-dihydro-5H-dibenzo[b,f]azepine (N- N


13080-75-6 25mg
0025 Acetyliminodibenzyl)

Imiquimod

N
MM1158.00 Imiquimod 99011-02-6 250mg N

N N H2

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-313
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N
MM1158.01- N
Imiquimod N-Oxide 1807607-22-2 25mg
0025
+
N NH2
O

1-Isobutyl-1H-imidazo[4,5-c]quinoline (Desaminoimiquimod)
N
MM1158.02 Related compound A (USP): 1-Isobutyl-1H-imidazo[4,5-c] 99010-24-9 100mg N
quinoline
N

1-Isobutyl-1H-imidazo[4,5-c]quinoline (Desaminoimiquimod)
MM1158.02- N
Related compound A (USP): 1-Isobutyl-1H-imidazo[4,5-c] 99010-24-9 25mg N
0025
quinoline
N

1-Isobutyl-1H-imidazo[4,5-c]quinoline 5-Oxide
N
(Desaminoimiquimod N-Oxide) N
MM1158.03 99010-63-6 100mg
Related compound B (USP): 1-Isobutyl-1H-imidazo[4,5-c]
quinoline 5-oxide +
N
O

1-Isobutyl-1H-imidazo[4,5-c]quinoline 5-Oxide
N
MM1158.03- (Desaminoimiquimod N-Oxide) N
99010-63-6 25mg
0025 Related compound B (USP): 1-Isobutyl-1H-imidazo[4,5-c]
quinoline 5-oxide +
N
O

4-Chloro-1-isobutyl-1H-imidazo[4,5-c]quinoline
N
MM1158.04 Related compound C (USP): 4-Chloro-1-isobutyl-1H-imidazo 99010-64-7 100mg N
[4,5-c]quinoline
N Cl

4-Chloro-1-isobutyl-1H-imidazo[4,5-c]quinoline
MM1158.04- N
Related compound C (USP): 4-Chloro-1-isobutyl-1H-imidazo 99010-64-7 25mg N
0025
[4,5-c]quinoline
N Cl

1-Propyl-1H-imidazo[4,5-c]quinolin-4-amine
MM1158.05- N
Related compound D (USP): 1-Propyl-1H-imidazo[4,5-c] 853792-81-1 25mg N
0025
quinolin-4-amine
N N H2

N4-Isobutylquinoline-3,4-diamine
NH
MM1158.06 Related compound E (USP): N4-Isobutylquinoline-3,4- 99010-09-0 100mg NH2
diamine
N

N4-Isobutylquinoline-3,4-diamine
MM1158.06- NH
Related compound E (USP): N4-Isobutylquinoline-3,4- 99010-09-0 25mg NH2
0025
diamine
N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-314
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N4-Isobutylquinoline-3,4-diamine Hydrochloride
NH
HCl
MM1158.07 Related compound E (USP): N4-Isobutylquinoline-3,4- 935521-01-0 100mg NH2

diamine N

N4-Isobutylquinoline-3,4-diamine Hydrochloride
MM1158.07- NH
HCl
Related compound E (USP): N4-Isobutylquinoline-3,4- 935521-01-0 25mg NH2
0025
diamine N

Indanazoline Hydrochloride

MM0588.02-
4-Aminoindan Hydrochloride 2172482-73-2 25mg HCl
0025 NH2

Indapamide
O O O

MM0477.00 Indapamide 26807-65-8 250mg H 2N


S
N
H
N

Cl

Impurity A (EP): (2RS)-2-Methyl-1-nitroso-


MM0477.01 2,3-dihydro-1H-indole 85440-79-5 100mg O N
N
Related compound D (USP)

Impurity A (EP): (2RS)-2-Methyl-1-nitroso-


MM0477.01-
2,3-dihydro-1H-indole 85440-79-5 25mg O N
N
0025 Related compound D (USP)
Impurity B (EP): 4-Chloro-N-(2-methyl-1H-
O
indol-1-yl)-3-sulphamoylbenzamide H 2N
O O
S
N
N
MM0477.02
Related compound A (USP): 4-chloro-N-(2-methyl-1H-indol-
63968-75-2 100mg H
Cl

1-yl)-3-sulfamoylbenzamide
Impurity B (EP): 4-Chloro-N-(2-methyl-1H-
O
MM0477.02- indol-1-yl)-3-sulphamoylbenzamide H 2N
O O
S
N
N

Related compound A (USP): 4-chloro-N-(2-methyl-1H-indol-


63968-75-2 25mg H
0025 Cl

1-yl)-3-sulfamoylbenzamide
Impurity C (EP) as Hydrochloride: (2RS)-2-Methyl-2,3-
dihydro-1H-indol-1-amine Hydrochloride (1-Amino-2- N HCl
methylindoline Hydrochloride)
MM0477.09 31529-47-2 100mg H 2N

Related compound B (USP): 2-Methylindolin-1-amine


Impurity C (EP) as Hydrochloride: (2RS)-2-Methyl-2,3-
MM0477.09- dihydro-1H-indol-1-amine Hydrochloride (1-Amino-2- N HCl
methylindoline Hydrochloride)
31529-47-2 25mg H 2N
0025
Related compound B (USP): 2-Methylindolin-1-amine
O
4-Chloro-3-sulfamoylbenzoic Acid O O
S
MM0477.04 Related compound E (USP): 4-Chloro-3-sulfamoylbenzoic 1205-30-7 100mg H 2N OH

acid Cl

O
MM0477.04- 4-Chloro-3-sulfamoylbenzoic Acid O O
S
Related compound E (USP): 4-Chloro-3-sulfamoylbenzoic 1205-30-7 25mg H 2N OH
0025 acid Cl

O O O
N-(4-Chloro-3-sulfamoylbenzoyl)-2- H2 N
S
N

methylindoline
MM0477.05 n/a 100mg
Cl

O O O
MM0477.05- N-(4-Chloro-3-sulfamoylbenzoyl)-2- H2 N
S
N

methylindoline
n/a 25mg
0025 Cl

MM0477.06-
2-Methylindole 95-20-5 25mg HN
0025

MM0477.07 Triethylamine 121-44-8 100mg N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-315
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

2-Methylindoline
MM0477.08
Related compound C (USP): 2-Methylindoline
6872-06-6 100mg HN

Indometacin (Indomethacin)
O
OH
N

MM0584.00 Indometacin 53-86-1 500mg Cl


O

O
Impurity A (EP): 4-Chlorobenzoic Acid OH
Related compound B (USP): 4-chlorobenzoic acid
MM0063.03 74-11-3 100mg
Cl

O
MM0063.03- Impurity A (EP): 4-Chlorobenzoic Acid OH
Related compound B (USP): 4-chlorobenzoic acid
74-11-3 25mg
0025
Cl

O
Cl OH
Impurity G (EP): [1-(3,4-Dichlorobenzoyl)-5-methoxy-2- N
MM0584.02- O
402849-26-7 25mg Cl
0025 methyl-1H-indol-3-yl]acetic Acid (3,4-Dichloroindometacin) O

O
O
Impurity H (EP): Methyl [1-(4-Chlorobenzoyl)-5-methoxy-2- N
O
MM0584.08 1601-18-9 100mg Cl
methyl-1H-indol-3-yl]acetate (Indomethacin Methyl Ester)
O

O
O
MM0584.08- Impurity H (EP): Methyl [1-(4-Chlorobenzoyl)-5-methoxy-2- N
O
1601-18-9 25mg Cl

0025 methyl-1H-indol-3-yl]acetate (Indomethacin Methyl Ester)


O

O
O
Impurity I (EP): Ethyl [1-(4-Chlorobenzoyl)-5-methoxy-2- N
O
MM0584.09 16401-99-3 100mg Cl
methyl-1H-indol-3-yl]acetate (Indomethacin Ethyl Ester)
O

O
O
MM0584.09- Impurity I (EP): Ethyl [1-(4-Chlorobenzoyl)-5-methoxy-2- N
O
16401-99-3 25mg Cl

0025 methyl-1H-indol-3-yl]acetate (Indomethacin Ethyl Ester)


O

O
O
N
O
MM0584.11 Indomethacin Isopropyl Ester 72616-25-2 100mg Cl

O
O
N
MM0584.11- O
Indomethacin Isopropyl Ester 72616-25-2 25mg Cl

0025 O

O
O
N
O OH
Cl

MM0584.12- O

Indometacin 1,3-Butylene Glycol Esters (Mixture of Isomers) n/a 25mg O

0025 O OH
N
O
Cl

O OH
O
N
MM0584.13- O
Indometacin 2,3-Butylene Glycol Ester 87293-45-6 25mg Cl

0025 O

O OH
O
N
O
Cl

MM0584.14- O

Indometacin 1,2-Propylene Glycol Esters (Mixture of Isomers) n/a 25mg O


0025 O
N OH
O
Cl

O OH
O OH
N
O
Cl

MM0584.15- O

Indometacin 1,2,3-Propanetriol Esters (Mixture of Isomers) n/a 25mg O

0025 O
N OH
O
Cl OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-316
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Indomethacin, see Indometacin

Indoramin Hydrochloride
H
N

MM0802.02 Impurity A (BP): 3-(2-Bromoethyl)indole 3389-21-7 100mg


Br

H
N
MM0802.02-
Impurity A (BP): 3-(2-Bromoethyl)indole 3389-21-7 25mg
0025
Br

MM0802.05- Impurity B (BP): N-(1-Benzyl-4-piperidyl)- H


N
971-34-6 25mg
0025 benzamide N O

H
MM0802.04- N
Impurity C (BP): N-(4-Piperidyl)benzamide 33953-37-6 25mg
0025 HN O

myo-Inositol
OH
OH
HO
MM0654.00 Impurity A (EP): D-Mannitol (Mannitol) 69-65-8 250mg OH
OH
HO

Iodipamide
O I
NH2
MM3337.01 3-Amino-2,4,6-triiodobenzoic Acid 3119-15-1 100mg HO

I I

O I
MM3337.01- NH2
3-Amino-2,4,6-triiodobenzoic Acid 3119-15-1 25mg HO
0025
I I

Iohexol
OH
H
O N OH

I I

MM1468.00 Iohexol 66108-95-0 250mg HO


N
H
N
OH
OH

I O
HO O

Impurity A (EP): 5-(Acetylamino)-N,N -bis(2,3- OH


H
O N OH

MM1468.02- dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide I I
OH
31127-80-7 25mg H
N OH
0025 Related compound A (USP): 5-(acetylamino)-N,N'-bis(2,3- HN
I O
O
dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide
Impurity J (EP): 5-Amino-N,N -bis(2,3-dihydroxypropyl)- O
H
N
OH
OH

MM1468.03- 2,4,6-triiodobenzene-1,3-dicarboxamide I I
OH
Related compound B (USP): 5-amino-N,N'-bis(2,3-
76801-93-9 25mg H
N OH
0025 H2 N

dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide I O

OH
H
N,N'-Bis(2,3-dihydroxypropyl)-5-nitro-1,3- O N OH

MM1468.01 benzenedicarboxamide 76820-34-3 100mg O


H
N
OH
OH
+
Related compound C (USP): N,N'-bis(2,3-dihydroxypropyl)-5- N
O O

OH
H

MM1468.01- N,N'-Bis(2,3-dihydroxypropyl)-5-nitro-1,3- O N OH

benzenedicarboxamide 76820-34-3 25mg O


H
N
OH
OH
+
0025 Related compound C (USP): N,N'-bis(2,3-dihydroxypropyl)-5- N
O O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-317
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Iopamidol
HO OH
O NH

MM0838.00 Iopamidol 60166-93-0 250mg O


I I
H
N
N OH
H
OH I O
OH

OH OH
Impurity A (EP): 5-Amino-N,N'-bis[2-hydroxy-1-
(hydroxymethyl)ethyl]-2,4,6-triiodobenzene-1,3- O NH
MM0838.01-
dicarboxamide 60166-98-5 25mg I I
0025 H
N
Related compound A (USP): N,N'-Bis-(1,3-dihydroxy-2- H2 N OH
I O
OH
propyl)-5-amino-2,4,6-triiodoiso-phthalamide

Iopydol
I
N OH

MM3117.00 Iopydol 5579-92-0 50mg O


OH

Ioversol
OH
H

MM1468.03- 5-Amino-N,N -bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene- O N OH

1,3-dicarboxamide 76801-93-9 25mg I I


H
N
OH
OH
0025 Related compound A (USP): 5-Amino-N,N'-bis(2,3- H2 N
I O

Ioxaglic Acid
O OH

MM3588.01- Impurity A (EP): 3-Amino-5-[(2-hydroxyethyl)carbamoyl]- I I

22871-58-5 25mg H
N
0025 2,4,6-triiodobenzoic Acid HO N H2
O I

Ioxilan
3-Amino-5-[(2-hydroxyethyl)carbamoyl]-2,4,6-triiodobenzoic O OH

MM3588.01- Acid I I

22871-58-5 25mg H
N
0025 Related compound A (USP): 5-amino-2,4,6-triiodo-3 N-(2- HO N H2
O I
hydroxyethyl)carbamoyl benzoic acid

Ipecacuanha
N

MM0131.02 Emetine Dihydrochloride 316-42-7 100mg O


H
HN
H
O
HCl
2

O
O

Ipragliflozin
S
F

MM3943.00-
Ipragliflozin 761423-87-4 250mg
0250 O
OH
HO
HO OH

Ipratropium Bromide
Mixed
H
O

MM1249.00 Ipratropium Bromide Monohydrate 66985-17-9 250mg &1


H
O
N
+
Br
H2 O
OH H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-318
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic O


Acid (dl-Tropic Acid)
MM0601.03 OH
Related compound C (USP): (2-RS)-3-hydroxy-2-
552-63-6 100mg
phenylpropanoic acid OH

Impurity C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic O


MM0601.03- Acid (dl-Tropic Acid)
552-63-6 25mg OH
0025 Related compound C (USP): (2-RS)-3-hydroxy-2-
phenylpropanoic acid OH

MM0289.03 Impurity D (EP): 2-Phenylpropenoic Acid (Atropic Acid) 492-38-6 100mg OH

O
MM0289.03-
Impurity D (EP): 2-Phenylpropenoic Acid (Atropic Acid) 492-38-6 25mg OH
0025

AND Enantiomer
H
MM1249.05- Impurity E (EP): (1R,3r,5S)-8-(1-Methylethyl)-8-azabicyclo O
H
N
22235-81-0 25mg O

0025 [3.2.1]oct-3-yl (2RS)-3-Hydroxy-2-phenylpropanoate OH H

Impurity F (EP) as Bromide: (1R,3r,5S,8r)-8-Methyl-8-(1- H


O
MM1249.06- H
N
+
Br
methylethyl)-3-[(2-phenylpropenoyl)oxy]-8-azoniabicyclo 60018-35-1 25mg O

0025 H

[3.2.1]octane Bromide (Apoipratropium Bromide)

Iproniazid Phosphate
O
H
N O OH

MM1107.00 Iproniazid Phosphate 305-33-9 100mg N


N
H HO
P
OH

Irbesartan
O N N
HN N
N

MM0862.00 Irbesartan 138402-11-6 250mg N

Impurity A (EP): 1-(Pentanoylamino)-N-[[2'-(1H-


tetrazol-5-yl)biphenyl-4-yl]methyl]cyclo- O N N
HN N
MM0862.01- pentanecarboxamide NH
N
H

Related compound A (USP): 1-pentanoylamino-


748812-53-5 25mg O
0025
cyclopentanecarboxylic acid [2'-(1H-tetrazol-5-yl)-biphenyl-4-
ylmethyl]-amide
O
N
4'-[(2-Butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl] N

MM0862.03 138401-24-8 100mg N

[1,1'-biphenyl]-2-carbonitrile
O
N
MM0862.03- 4'-[(2-Butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl] N

138401-24-8 25mg N

0025 [1,1'-biphenyl]-2-carbonitrile
O

MM0862.04- NH
HCl
2-Butyl-1,3-diazaspiro[4.4]non-1-en-4-one Hydrochloride 151257-01-1 25mg N
0025
O
MM0862.05- HCl
Ethyl 1-Aminocyclopentanecarboxylate Hydrochloride 22649-37-2 25mg O
0025 NH2

O N N
HN N
MM0862.07- 3-[[2'-(1H-Tetrazol-5-yl)biphenyl-4-yl]methyl]-1,3-diazaspiro N

1312996-18-1 25mg N
H
O
0025 [4.4]nonane-2,4-dione
N

MM0862.08-
4'-Methylbiphenyl-2-carbonitrile 114772-53-1 25mg
0025

N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-319
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N
MM0487.10A N O
N-Nitrosodiethylamine (NDEA) 0.1 mg/ml in Methanol 55-18-5 1ml
ME-00.10
O N N
HN N
MM0862.21- N-[[2'-(1H-Tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl] N
H
914465-68-2 25mg
0025 pentanamide

MM0862.28- 2-Butyl-3-[[2'-[2-(triphenylmethyl)-2H-tetrazol-5-yl][1,1'- O N N

886999-35-5 25mg N N
N
0025 biphenyl]-4-yl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one N

Irganox 245
O

O
MM3895.01-
Ethyl 3-(3-tert-Butyl-4-hydroxy-5-methylphenyl)propionate 40200-35-9 25mg HO
0025

Irinotecan Hydrochloride Trihydrate


O
H2 O

Irinotecan Hydrochloride Trihydrate


N O 3

O
O HCl
MM1157.00 136572-09-3 100mg N
N
O
N HO

Impurity B (EP): (4S)-4-Ethyl-4,9-dihydroxy-1H-pyrano


[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (9- O

MM1157.02- N O
Hydroxycamptothecin; (S)-10-Hydroxycamptothecin) 19685-09-7 25mg O
N HO
0025 HO

Related compound A (USP): (S)-4-ethyl-4,9-dihydroxy-1H-


pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione
O
Impurity D (EP): (4S)-4-Ethyl-4-hydroxy-1H-pyrano[3',4':6,7] N
MM1330.02- N
indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (Camptothecin; 7689-03-4 25mg O
0025
(S)-(+)-Camptothecin) HO O

Impurity E (EP): (4S)-4,11-Diethyl-4,9-dihydroxy-1H-pyrano


[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (11-
O O
Ethyl-9-hydroxycamptothecin; 7-Ethyl-10- N
O

MM1157.01- hydroxycamptothecin) OH
86639-52-3 25mg N
0025 Related compound B (USP): (S)-4,11-diethyl-4,9-dihydroxy-
HO

1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-
dione

Impurity F (EP): (4S)-4,11-Diethyl-4-hydroxy-1H-pyrano


O O
[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (11- O
N
MM1157.05- Ethylcamptothecin; 7-Ethyl-20(S)-camptothecin) OH
78287-27-1 25mg
0025 N

Related compound E (USP): (S)-4,11-Diethyl-4-hydroxy-1H-


pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione

MM1157.07- N NH
1,4'-Bipiperidine (4-Piperidinopiperidine) 4897-50-1 25mg
0025

[1,4'-Bipiperidine]-1'-carboxylic Acid 12-Ethyl-9,11-dihydro-8- N

MM1330.03- N O
N
O

methyl-9-oxo-7-(1-oxopropyl)indolizino[1,2-b]quinolin-2-yl 176515-52-9 25mg O


N

0025
O
Ester

Isavuconazonium Sulfate
N

N N
HO S
N
MM3613.01 Isavuconazole 241479-67-4 100mg F
N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-320
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N N
MM3613.01- HO S
N
Isavuconazole 241479-67-4 25mg F
N
0025 F

Isoamyl Benzoate
O

MM1086.00 Isoamyl Benzoate 94-46-2 500mg O

Isobutyl p-Aminobenzoate
O

MM3114.00 Isobutyl p-Aminobenzoate 94-14-4 100mg O

H2 N

Isoconazole Nitrate
Cl

O
MM0541.00- Cl Cl
Isoconazole Nitrate 24168-96-5 250mg O
HO N
+

O
0250 N
Cl
N

Cl
Impurity A (EP): (1RS)-1-(2,4-Dichlorophenyl)-
MM0281.01 24155-42-8 100mg N
2-(1H-imidazol-1-yl)ethanol Cl OH
N

Cl
MM0281.01- Impurity A (EP): (1RS)-1-(2,4-Dichlorophenyl)-
24155-42-8 25mg N
0025 2-(1H-imidazol-1-yl)ethanol Cl OH
N

Cl

Impurity B (EP) as Nitrate: (2RS)-2-[(2,6-


O
MM0541.02 Dichlorobenzyl)oxy]-2-(2,4- n/a 100mg Cl Cl
HO N
+

O
dichlorophenyl)ethanamine Nitrate O
NH2
Cl

Cl

MM0541.02- Impurity B (EP) as Nitrate: (2RS)-2-[(2,6-


O
Dichlorobenzyl)oxy]-2-(2,4- n/a 25mg Cl Cl
HO N
+

O
0025 dichlorophenyl)ethanamine Nitrate O
NH2
Cl

Cl

Impurity C (EP) as Nitrate: 1-[(2RS)-2-[(2,4-


MM0281.00- Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)- Cl
HO N
O
+

22832-87-7 250mg
0250 ethyl]-1H-imidazole Nitrate O
N
O

Cl Cl
(Miconazole Nitrate) N

Isoflurane
Cl F
MM0500.00- F
Isoflurane 26675-46-7 250mg O F
0250
F F

Impurity C (EP): (2RS)-2-Chloro-2-


Cl F F
(chlorodifluoromethoxy)-1,1,1-
F
MM0500.03 trifluoroethane 32778-08-8 100mg O Cl
Related compound A (USP): 1-chloro-2,2,2-trifluoroethyl F F
chlorodifluoromethyl ether
Cl Cl F
Impurity D (EP): 1,1-Dichloro-1-(difluoromethoxy)- F
MM0500.04 32778-07-7 100mg O F
2,2,2-trifluoroethane
F F

Cl Cl F F
Impurity E (EP): 1,1-Dichloro-1-
F
MM0500.05 (chlorodifluoromethoxy)-2,2,2- 32778-09-9 100mg O Cl
trifluoroethane F F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-321
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Isoleucine
NH2
OH
MM1564.00 Isoleucine (L-Isoleucine) 73-32-5 250mg
O

Isoniazid
O
MM1529.00- NH2
Isoniazid 54-85-3 250mg N
H
0250 N

MM0553.03 Impurity A (EP): Pyridine-4-carboxylic Acid (Isonicotinic Acid) 55-22-1 100mg OH

N
MM0553.03- OH
Impurity A (EP): Pyridine-4-carboxylic Acid (Isonicotinic Acid) 55-22-1 25mg
0025
O

MM0552.01 Impurity B (EP): Pyridine-4-carboxamide (Isonicotinamide) 1453-82-3 100mg NH2


N

O
MM0552.01-
Impurity B (EP): Pyridine-4-carboxamide (Isonicotinamide) 1453-82-3 25mg NH2
0025 N

MM0845.03 Impurity C (EP): Pyridine-4-carbonitrile (Isonicotinonitrile) 100-48-1 100mg


N

N
MM0845.03-
Impurity C (EP): Pyridine-4-carbonitrile (Isonicotinonitrile) 100-48-1 25mg
0025 N

MM1529.01- O
2-Isoniazid 1452-63-7 25mg N
0025
HN
N H2

Isoprenaline Sulfate (Isoproterenol Sulfate)


OH
H

Isoprenaline Sulfate Dihydrate


HO N O O
S H2O
HO OH 2
MM1659.00 6078-56-4 250mg HO
2

Isopropyl Palmitate
O

MM1479.00 Isopropyl Palmitate 142-91-6 100mg O

2-Isopropylthioxanthone (2-ITX)
O
MM2585.00-
2-Isopropylthioxanthone (2-ITX) 5495-84-1 250mg
0250 S

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-322
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Isoproterenol Sulfate, see Isoprenaline Sulfate

Isoproturon

H
MM2503.02- N N
3-(2-Isopropylphenyl)-1,1-dimethylurea 70214-90-3 25mg
0025 O

H
MM2503.03- N N
3-(3-Isopropylphenyl)-1,1-dimethylurea 55304-10-4 25mg
0025 O

Isosorbide Dinitrate, Diluted


O
+
O N
H
O
O
MM0126.05 Impurity B (EP): Isosorbide 2-Nitrate 16106-20-0 100mg
O
HO H

O
+
O N
H
O
MM0126.05- O
Impurity B (EP): Isosorbide 2-Nitrate 16106-20-0 25mg
0025
O
HO H

H OH
O
MM0502.00- Impurity C (EP): Isosorbide Mononitrate
16051-77-7 250mg O
0250 (Isosorbide 5-Nitrate) O
+ O H
N
O

H O
O
MM0126.02 Dimethyl Isosorbide 5306-85-4 100mg
O
H
O

H OH
O
MM0126.03 Isosorbide 652-67-5 500mg
O
HO H

Isosorbide Mononitrate
H OH
O
MM0502.00-
Isosorbide Mononitrate 16051-77-7 250mg O
0250 O H
+ O
N
O

O
+
N
Impurity C (EP): Isosorbide 2-Nitrate H O
O
O
MM0126.05 Related compound A (USP): 1,4:3,6-Dianhydro-D-glucitol 2- 16106-20-0 100mg
nitrate in lactose O
HO H

O
+
N
Impurity C (EP): Isosorbide 2-Nitrate H O
O
MM0126.05- O
Related compound A (USP): 1,4:3,6-Dianhydro-D-glucitol 2- 16106-20-0 25mg
0025 nitrate in lactose O
HO H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-323
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

H OH
O
MM0126.03 Isosorbide 652-67-5 500mg
O
HO H

H O
MM0502.03- O
Isosorbide 2-Acetate 13042-39-2 25mg
0025
O
HO H

Isothipendyl Hydrochloride

N
N
MM1009.00 Isothipendyl Hydrochloride 1225-60-1 100mg S
N
HCl

N
MM1009.07- N,N,ß-Trimethyl-10H-pyrido[3,2-b][1,4]benzothiazine-10- N HCl
132962-42-6 25mg S
N
0025 ethanamine Hydrochloride (ß-Isothipendyl Hydrochloride)

MM0486.04- NH
1-Azaphenothiazine 261-96-1 25mg
0025 S
N

Isotretinoin
O

MM1110.00 Impurity A (EP): Tretinoin 302-79-4 250mg OH

MM0143.15- O
trans- -Ionone 79-77-6 100mg
0100

Isoxepac
O
O

MM0430.00 Isoxepac 55453-87-7 250mg HO


O

Isoxsuprine Hydrochloride
AND Enantiomer
OH

MM0576.00 Isoxsuprine Hydrochloride 579-56-6 500mg H


N
O
HCl

HO

Isradipine
H
N

O O

MM0466.00 Isradipine 75695-93-1 250mg O O


N
O
N

Itraconazole
AND Enantiomer

O Cl
N
MM0258.00- N
N

84625-61-6 1000mg Cl
Itraconazole N O
O
N
N

N
1000 N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-324
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N N

O
N

Impurity A (EP): 4-[4-[4-(4-Methoxyphenyl)piperazin-


MM0258.02 1-yl]phenyl]-2-[(1RS)-1-methylpropyl]-2,4-dihydro- 252964-68-4 100mg N
3H-1,2,4-triazol-3-one
N

N N

O
N

MM0258.02- Impurity A (EP): 4-[4-[4-(4-Methoxyphenyl)piperazin-


1-yl]phenyl]-2-[(1RS)-1-methylpropyl]-2,4-dihydro- 252964-68-4 25mg N
0025 3H-1,2,4-triazol-3-one
N

Impurity C (EP): 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)- AND Enantiomer

2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]-
Cl
O
N
N
N

MM0258.04 Cl
74855-91-7 100mg
methoxy]phenyl]piperazin-1-yl]phenyl]-2-propyl- N
N
O
O
N
N

2,4-dihydro-3H-1,2,4-triazol-3-one O

Impurity C (EP): 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)- AND Enantiomer

2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]-
Cl
O
MM0258.04- N
N
N
Cl
74855-91-7 25mg
0025 methoxy]phenyl]piperazin-1-yl]phenyl]-2-propyl- N
N
O
O
N
N

2,4-dihydro-3H-1,2,4-triazol-3-one O

Impurity D (EP): 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)- AND Enantiomer


Cl

MM0258.05- 2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]- N
N

N
O

Cl
N
89848-49-7 25mg
methoxy]phenyl]piperazin-1-yl]phenyl]-2-(1- N O N

N O N
0025 O

methylethyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
AND Enantiomer

N N

O
N

Impurity F (EP): 2-Butyl-4-[4-[4-[4-[[cis-2-(2,4-dichloro-


phenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan- N
MM0258.07 89848-51-1 100mg
4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2,4- N

dihydro-3H-1,2,4-triazol-3-one O
Cl Cl

O O
N
N
N

AND Enantiomer

N N

O
N

Impurity F (EP): 2-Butyl-4-[4-[4-[4-[[cis-2-(2,4-dichloro-


MM0258.07- phenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan- N
89848-51-1 25mg
0025 4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2,4- N

dihydro-3H-1,2,4-triazol-3-one O
Cl Cl

O O
N
N
N

O
N N OH
MM0145.05 1-Acetyl-4-(4-hydroxyphenyl)piperazine 67914-60-7 100mg

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-325
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0145.05- O
N N OH
1-Acetyl-4-(4-hydroxyphenyl)piperazine 67914-60-7 25mg
0025

MM0258.10- 2,4-Dihydro-4-[4-[4-(4-methoxyphenyl)-1- HN
O

N N N O
74853-07-9 25mg
0025 piperazinyl]phenyl]-3H-1,2,4-triazol-3-one N

AND Enantiomer
Cl Cl

cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1- O
O

MM0258.11
ylmethyl)-1,3-dioxolane-4-methanol Mesilate
67914-86-7 100mg S O
N
O O
N
N

AND Enantiomer
Cl Cl

MM0258.11- cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1- O
O

ylmethyl)-1,3-dioxolane-4-methanol Mesilate
67914-86-7 25mg S O
N
O O
0025 N
N

N N

N O

4-[4-[4-(4-Hydroxyphenyl)piperazin-1-yl]phenyl]-2-[(1RS)-1-
MM0258.17 106461-41-0 100mg
methylpropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one N

OH

N N

N O

MM0258.17- 4-[4-[4-(4-Hydroxyphenyl)piperazin-1-yl]phenyl]-2-[(1RS)-1-
106461-41-0 25mg
0025 methylpropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one N

OH

Cl Cl

MM0145.09- [2-(Bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl] O
68751-57-5 100mg HO
0100 methanol O
Br

Ivabradine Hydrochloride
O

MM3982.10- O
1,3-Dihydro-7,8-dimethoxy-2H-3-benzazepin-2-one 73942-87-7 25mg O
0025 NH

O
MM3982.20-
3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-triene-7-carbonitrile 35202-54-1 25mg O
0025 N

Ivacaftor
H
N
H
MM3921.00- N
Ivacaftor 873054-44-5 250mg O O
0250
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-326
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Kaempferol
OH

HO O

MM1542.00 Kaempferol 520-18-3 250mg


OH
OH O

Ketamine Hydrochloride
O
Cl
MM0144.00- NH
HCl
Ketamine Hydrochloride 1867-66-9 250mg
0250

Impurity A (EP): 1-[(2-Chlorophenyl)- N Cl


HO
(methylimino)methyl]cyclopentanol
MM0144.01
Related compound A (USP): 1-[(2-Chlorophenyl)
6740-87-0 100mg
(methylimino)methyl]cylcopentanol

Impurity A (EP): 1-[(2-Chlorophenyl)- N Cl


HO
MM0144.01- (methylimino)methyl]cyclopentanol
Related compound A (USP): 1-[(2-Chlorophenyl)
6740-87-0 25mg
0025
(methylimino)methyl]cylcopentanol
O
OH Cl
Impurity B (EP): (2RS)-2-(2-Chloro-
MM0144.02 n/a 100mg
phenyl)-2-hydroxycyclohexanone

O
OH Cl
MM0144.02- Impurity B (EP): (2RS)-2-(2-Chloro-
n/a 25mg
0025 phenyl)-2-hydroxycyclohexanone

O Cl
HO
Impurity C (EP): (2-Chlorophenyl)(1-
MM0144.03 90717-17-2 100mg
hydroxycyclopentyl)methanone

O
Cl
N H2
HCl
MM0144.06 Norketamine Hydrochloride 79499-59-5 100mg

O
Cl
MM0144.06- N H2
HCl
Norketamine Hydrochloride 79499-59-5 25mg
0025
O
Cl
MM0144.07- NH2
Dehydronorketamine Hydrochloride 1435934-26-1 25mg HCl
0025

O
Cl
NH
MM0144.09 N-Ethylnorketamine Hydrochloride n/a 100mg HCl

O
Cl
MM0144.09- NH
N-Ethylnorketamine Hydrochloride n/a 25mg HCl

0025

O
Cl
MM0144.10- NH
HCl
(R)-Ketamine Hydrochloride 33795-24-3 25mg
0025

Ketanserin Hydrogen Tartrate


O
HN
HCl
MM3713.01 4-(4-Methoxybenzoyl)piperidine Hydrochloride 25519-82-8 100mg
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-327
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
HN
MM3713.01- HCl
4-(4-Methoxybenzoyl)piperidine Hydrochloride 25519-82-8 25mg
0025 O

Ketoconazole
AND Enantiomer
Cl Cl

O
MM0145.00-
Ketoconazole 65277-42-1 250mg N
O
O
N

N
O N
0250

Impurity D (EP): 1-[4-[[(2RS,4SR)-2-(2,4- Cl

O
AND Enantiomer
Cl

MM0145.04 Dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)- 67914-61-8 100mg N


O O
N

1,3-dioxolan-4-yl]methoxy]phenyl]piperazine
N
HN

MM0145.04- Impurity D (EP): 1-[4-[[(2RS,4SR)-2-(2,4- Cl

O
AND Enantiomer
Cl

Dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)- 67914-61-8 25mg N


O O
N

1,3-dioxolan-4-yl]methoxy]phenyl]piperazine
0025 N
HN

AND Enantiomer
Cl Cl

Impurity E (EP): [(2RS,4SR)-2-(2,4-Dichlorophenyl)-2- O


O

(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methyl
O
O S O
MM0145.06 134071-44-6 100mg N

4-Methylbenzenesulfonate N

AND Enantiomer
Cl Cl

MM0145.06- Impurity E (EP): [(2RS,4SR)-2-(2,4-Dichlorophenyl)-2- O


O

(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methyl
O
O S O
134071-44-6 25mg N

0025 4-Methylbenzenesulfonate N

MM0145.05 1-Acetyl-4-(4-hydroxyphenyl)piperazine 67914-60-7 100mg N N OH

MM0145.05- O

1-Acetyl-4-(4-hydroxyphenyl)piperazine 67914-60-7 25mg N N OH

0025
AND Enantiomer
Cl Cl

O
O
O N
MM0145.07 Ketoconazole N-Oxide 254912-65-7 100mg N
+
N
O N

Cl Cl

MM0145.09- [2-(Bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl] O
68751-57-5 100mg HO
0100 methanol O
Br

Ketoprofen
O
OH
MM0001.00 Ketoprofen 22071-15-4 500mg O

Impurity A (EP): 1-(3-Benzoylphenyl)ethanone O O

MM0001.01 (3-Acetylbenzophenone) 66067-44-5 100mg


Related compound D (USP): 3-acetylbenzophenone
Impurity A (EP): 1-(3-Benzoylphenyl)ethanone O O
MM0001.01-
(3-Acetylbenzophenone) 66067-44-5 25mg
0025 Related compound D (USP): 3-acetylbenzophenone
O
OH
MM0001.03 Impurity B (EP): (3-Benzoylphenyl)acetic Acid 22071-22-3 100mg O

O
MM0001.03- OH
Impurity B (EP): (3-Benzoylphenyl)acetic Acid 22071-22-3 25mg O
0025
Impurity C (EP): 3-[(1RS)-1-Carboxyethyl]- O
benzoic Acid HO
OH

Related compound C (USP): 2-(3-carboxyphenyl)propionic


MM0001.07 68432-95-1 100mg
O

acid
Impurity C (EP): 3-[(1RS)-1-Carboxyethyl]- O
MM0001.07- benzoic Acid HO
OH

Related compound C (USP): 2-(3-carboxyphenyl)propionic


68432-95-1 25mg
0025 O

acid

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-328
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity D (EP): (2RS)-2-[3-(4-Methylbenzoyl)-


O
phenyl]propanoic Acid OH

Related compound A (USP): alpha-methyl-3-(4-


MM0001.12 107257-20-5 100mg O

methylbenzoyl) benzeneacetic acid


Impurity D (EP): (2RS)-2-[3-(4-Methylbenzoyl)-
O
MM0001.12- phenyl]propanoic Acid OH

Related compound A (USP): alpha-methyl-3-(4-


107257-20-5 25mg O
0025
methylbenzoyl) benzeneacetic acid
O
Impurity E (EP): (2RS)-2-(3-Benzoylphenyl)- N H2
MM0001.05 59512-16-2 100mg
propanamide O

O
MM0001.05- Impurity E (EP): (2RS)-2-(3-Benzoylphenyl)- N H2
59512-16-2 25mg
0025 propanamide O

Impurity F (EP): (2RS)-2-(3-Benzoylphenyl)- O


propanenitrile
MM0001.04
Related compound F (USP): 3-(1-Cyanoethyl)
42872-30-0 100mg N

benzophenone
Impurity F (EP): (2RS)-2-(3-Benzoylphenyl)- O
MM0001.04- propanenitrile
Related compound F (USP): 3-(1-Cyanoethyl)
42872-30-0 25mg N
0025
benzophenone
O
Impurity G (EP): 3-[(1RS)-1-Cyanoethyl]- HO
MM0001.20 5537-71-3 100mg
benzoic Acid N

O
MM0001.20- Impurity G (EP): 3-[(1RS)-1-Cyanoethyl]- HO
5537-71-3 25mg
0025 benzoic Acid N

MM0001.22 Impurity H (EP): 3-(Cyanomethyl)benzoic Acid 5689-33-8 100mg HO


N

O
MM0001.22-
Impurity H (EP): 3-(Cyanomethyl)benzoic Acid 5689-33-8 25mg HO
N
0025
O

MM0001.14 Impurity I (EP): (3-Benzoylphenyl)ethanenitrile 21288-34-6 100mg N

O
Impurity J (EP): (2RS)-2-[3-(2,4-Dimethylbenzoyl)- OH
MM0001.23 1785759-59-2 50mg
phenyl]propanoic Acid O

MM0001.02 3-Ethylbenzophenone 66067-43-4 100mg

O OH

MM0001.11 3-(1-Hydroxyethyl)benzophenone 67173-18-6 100mg

MM0001.13 3-Methylbenzophenone 643-65-2 100mg

O O

MM0001.17 3-(1-Methoxyethyl)benzophenone 2731671-45-5 100mg

OH

2-[3-( -Hydroxybenzyl)phenyl]- OH
MM0001.18 59960-32-6 100mg
propanoic Acid O

OH
MM0001.18- 2-[3-( -Hydroxybenzyl)phenyl]- OH
59960-32-6 25mg
0025 propanoic Acid O

O
Ethyl 2-(3-Benzoylphenyl)propionate O
MM0001.19
(Ketoprofen Ethyl Ester)
60658-04-0 100mg O

O
O
MM0001.21 Isopropyl 2-(3-Benzoylphenyl)propionate 220662-26-0 100mg O

O O

MM0001.50 3-(1-Acetoxyethyl)benzophenone 2377141-19-8 100mg O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-329
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O OH
O

Ketoprofen Propylene Glycol Ester O

(Mixture of Isomers)
MM0001.28 n/a 50mg O
OH
O

MM0001.31 Methyl 2-Cyanomethylbenzoate 5597-04-6 100mg O


N

O
MM0001.31-
Methyl 2-Cyanomethylbenzoate 5597-04-6 25mg O
N
0025

O
Methyl 2-(3-Benzoylphenyl)propionate O

(Ketoprofen Methyl Ester)


MM0001.32 47087-07-0 100mg O

O
MM0001.32- Methyl 2-(3-Benzoylphenyl)propionate O

(Ketoprofen Methyl Ester)


47087-07-0 25mg O
0025

2-Ethylhexyl 2-(3-Benzoylphenyl)propionate O
O

(Ketoprofen 2-Ethylhexyl Ester)


MM0001.33 n/a 100mg O

O
O

O OH
Ketoprofen 1,3-Butylene Glycol Esters (Mixture of Regio- and
MM0001.34 n/a 100mg O
Stereoisomers) O OH

O OH
O
MM0001.35 Ketoprofen 2,3-Butylene Glycol Ester 94561-67-8 100mg O

O OH
O OH

O
Ketoprofen 1,2,3-Propanetriol Esters (Mixture of Regio- and
MM0001.36 n/a 50mg O
Stereoisomers) O
OH
O
OH

Ketoprofen Lysinate
O
OH

MM3602.00 Ketoprofen Lysinate 57469-78-0 250mg O


H 2N
OH
N H2

Ketorolac Trometamol
O
OH

MM0851.00 Ketorolac Trometamol 74103-07-4 250mg O


N
OH
HO
N H2
OH

Impurity B (EP): 5-Benzoyl-2,3-dihydro-1H-pyrrolizin-1-one


MM0851.02- (Ketorolac 1-Keto Analog) O
113502-52-6 25mg N
0025 Related compound C (USP): 5-benzoyl-2,3-dihydro-1H- O

pyrrolizin-1-one
Impurity E (EP): (1RS)-5-Benzoyl-N-[2-hydroxy-
1,1-bis(hydroxymethyl)ethyl]-2,3-dihydro-1H- OH

MM0851.07- pyrrolizine-1-carboxamide O

N
OH

Related compound A (USP): 5-benzoyl-N-(1,3-dihydroxy-2-


167105-80-8 25mg N H
OH
0025 O

(hydroxymethyl)propan-2-yl)-2,3-dihydro-1H-pyrrolizine-1-
carboxamide
O
Impurity H (EP): Methyl (1RS)-5-Benzoyl-2,3-dihydro-1H- O
MM0851.10 80965-09-9 100mg N
pyrrolizine-1-carboxylate (Ketorolac Methyl Ester) O

O
MM0851.10- Impurity H (EP): Methyl (1RS)-5-Benzoyl-2,3-dihydro-1H- O
80965-09-9 25mg N
0025 pyrrolizine-1-carboxylate (Ketorolac Methyl Ester) O

Impurity I (EP): Phenyl(2,3-dihydro-1H-pyrrolizin-


MM0851.03- 5-yl)methanone
N
Related compound D (USP): 5-benzoyl-2,3-dihydro-1H-
113502-55-9 25mg
0025 O
pyrrolizine

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-330
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
Impurity J (EP): Ethyl (1RS)-5-Benzoyl-2,3-dihydro-1H- O
MM0851.11 108061-03-6 100mg N
pyrrolizine-1-carboxylate (Ketorolac Ethyl Ester) O

O
MM0851.11- Impurity J (EP): Ethyl (1RS)-5-Benzoyl-2,3-dihydro-1H- O
108061-03-6 25mg N

0025 pyrrolizine-1-carboxylate (Ketorolac Ethyl Ester) O

O
MM0851.12 6-Benzoyl-2,3-dihydro-1H-pyrrolizin-1-one n/a 100mg
N

O
MM0851.12- O
6-Benzoyl-2,3-dihydro-1H-pyrrolizin-1-one n/a 25mg
0025 N

O
MM0851.14- O
Ketorolac Isopropyl Ester 66635-74-3 25mg N

0025 O

O OH

O
N

MM0851.15- Ketorolac 1,3-Butylene Glycol Esters (Mixture of Regio- and O

n/a 25mg O

0025 Stereoisomers) N
O OH

O
MM0851.16- O
Ketorolac 2,3-Butylene Glycol Ester n/a 25mg N
OH
0025 O

O
N
OH
MM0851.17- Ketorolac 1,2-Propylene Glycol Esters (Mixture of Regio- and O

n/a 25mg O
0025 Stereoisomers) OH
O
N

O
MM0851.19- Ethyl 5-Benzoyl-1-hydroxy-2,3-dihydropyrrolizine-1- O
OH
n/a 25mg N
0025 carboxylate O

O
MM0851.20- Isopropyl 5-Benzoyl-1-hydroxy-2,3-dihydropyrrolizine-1- O
n/a 25mg OH
N
0025 carboxylate O

Ketotifen Hydrogen Fumarate


S N
O

MM0180.00 Ketotifen Hydrogen Fumarate 34580-14-8 250mg O


HO

O
OH

S N

MM0180.04 Ketotifen 34580-13-7 100mg O

S N
Impurity B (EP): (4RS)-10-Methoxy-4-(1-methyl-
MM0180.08 piperidin-4-yl)-4H-benzo[4,5]cyclohepta[1,2- 59743-88-3 100mg O OH

b]thiophen-4-ol

S N

MM0180.08- Impurity B (EP): (4RS)-10-Methoxy-4-(1-methyl-


piperidin-4-yl)-4H-benzo[4,5]cyclohepta[1,2- 59743-88-3 25mg O OH
0025 b]thiophen-4-ol

O
Impurity D (EP): 4-[(aRaS)-1-Methylpiperidin-4- S N
+

ylidene]-4,9-dihydro-10H-benzo[4,5]cyclo-
MM0180.07 88456-70-6 100mg O
hepta[1,2-b]thiophen-10-one N-Oxide
(Ketotifen N-Oxide)

S N
Impurity G (EP): 4-(1-Methylpiperidin-4-ylidene)-4H-benzo
MM0180.05- O
[4,5]cyclohepta[1,2-b]thiophen-9,10-dione (9,10- 43076-16-0 25mg
0025
Dioxoketotifen) O

S NH
O

MM0180.12 N-Desmethylketotifen Hydrogen Fumarate 930765-16-5 50mg O HO


OH
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-331
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

S
O
10-Methoxy-4H-benzo[4,5]cyclohepta[1,2- O
b]thiophen-4-one
MM0180.11 59743-84-9 100mg

S
O
MM0180.11- 10-Methoxy-4H-benzo[4,5]cyclohepta[1,2- O
b]thiophen-4-one
59743-84-9 25mg
0025

Labetalol Hydrochloride
OH
H
N
MM0438.00-
Labetalol Hydrochloride 32780-64-6 250mg HO
0250 HCl
O N H2

OH
H
MM0438.01- Impurity A (EP) as Hydrochloride: 2-Hydroxy-5-[1--[(1- N

2726492-68-6 25mg
0025 methyl-3-phenylpropyl)amino]-]benzoic Acid Hydrochloride HO

O OH
HCl

MM0438.02- Impurity B (EP) as Hydrochloride: Methyl 2-Hydroxy- OH


H
N

5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]- 33778-93-7 25mg HO


HCl

0025 ethyl]benzoate Hydrochloride O O

Lacidipine
H
N

O O
MM0407.00-
Lacidipine 103890-78-4 250mg O O
O

0250 O

H
N
Impurity A (BP): Ethyl Methyl (E)-4-{2-[2-(tert-Butoxy- O O

MM0407.01 carbonyl)vinyl]phenyl}-1,4-dihydro-2,6-dimethyl- 103890-81-9 100mg O O


O

O
pyridine-3,5-dicarboxylate
H
N

MM0407.01- Impurity A (BP): Ethyl Methyl (E)-4-{2-[2-(tert-Butoxy- O O

carbonyl)vinyl]phenyl}-1,4-dihydro-2,6-dimethyl- 103890-81-9 25mg O O


O

O
0025 pyridine-3,5-dicarboxylate
N

Impurity B (BP): Diethyl (E)-4-{2-[2-(tert-Butoxy- O O

MM0407.02 carbonyl)vinyl]phenyl}-2,6-dimethylpyridine- 130996-24-6 100mg O O


O

3,5-dicarboxylate
N

MM0407.02- Impurity B (BP): Diethyl (E)-4-{2-[2-(tert-Butoxy- O O

carbonyl)vinyl]phenyl}-2,6-dimethylpyridine- 130996-24-6 25mg O O


O

O
0025 3,5-dicarboxylate

Lacosamide
O
MM3640.00- O
Lacosamide 175481-36-4 250mg N
H
N
0250 H
O

MM3640.07- H
Impurity G (EP): N-Benzylacetamide N
588-46-5 25mg
0025
O

Lactitol Monohydrate
HO
OH
OH
HO

MM3549.00 Lactitol Monohydrate 81025-04-9 100mg HO


O O
OH
H2 O

HO OH
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-332
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
OH
HO
MM0654.00 Impurity C (EP): D-Mannitol (Mannitol) 69-65-8 250mg OH
OH
HO

OH
OH
HO
MM1492.00 Impurity E (EP): D-Glucitol (D-Sorbitol, Sorbitol) 50-70-4 250mg OH
OH
HO

Lactose Monohydrate
HO
HO O
O O OH H2O
MM1485.00 Lactose Monohydrate 5989-81-1 250mg HO
HO OH
HO OH

Lactulose
Mixed
O
OH
MM1562.00 Impurity D (EP): D-arabino-Hex-2-ulopyranose (D-Fructose) 57-48-7 250mg HO
&1
OH
HO OH

Lamivudine
NH2

MM0749.00- O N
Lamivudine 134678-17-4 250mg
0250
O
S
HO

MM0045.00- OH
Impurity C (EP): Salicylic Acid 69-72-7 250mg
0250
OH

NH2

MM0749.04- Impurity D (EP): 4-Amino-1-[(2S,5R)-2-(hydroxymethyl)-1,3-


134680-32-3 25mg O N
0025 oxathiolan-5-yl]pyrimidin-2(1H)-one
O
S
HO

NH2
Impurity B (EP) as single (R,R)-Enantiomer: 4-Amino-1-
MM0749.05- N
[(2R,5R)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2 71-30-7 25mg
0025
(1H)-one O N
H

MM0593.03- Impurity F (EP): Pyrimidine-2,4(1H,3H)-dione HN


66-22-8 25mg
0025 (Uracil)
O N
H

HN

MM0749.10- Impurity J (EP): 1-[(2R,5S)-2-(Hydroxymethyl)-1,3-


145986-07-8 25mg O N
0025 oxathiolan-5-yl]pyrimidine-2,4(1H,3H)-dione
O
S
HO

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-333
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

AND Enantiomer
NH2

N
MM0749.16-
rac-cis-Lamivudine ((2RS,5SR)-Lamivudine) 136891-12-8 25mg O N
0025 O
S
HO

Lamotrigine
N N H2
N
N
MM0922.00-
Lamotrigine 84057-84-1 250mg
0250 NH2
Cl
Cl

N N H2
Impurity A (EP): 3-Amino-6-(2,3-dichlorophenyl)- N
NH
1,2,4-triazin-5(4H)-one
MM0922.01
Related compound C (USP): 3-amino-6-(2,3-
252186-78-0 100mg O
Cl
dichlorophenyl)-1,2,4-triazin-5(4H)-one Cl

N N H2
Impurity A (EP): 3-Amino-6-(2,3-dichlorophenyl)- N
NH
MM0922.01- 1,2,4-triazin-5(4H)-one
Related compound C (USP): 3-amino-6-(2,3-
252186-78-0 25mg O
0025 Cl
dichlorophenyl)-1,2,4-triazin-5(4H)-one Cl

N N H2
N
NH2
Impurity C (EP): (2Z)-[2-(Diaminomethylidene)-
MM0922.03 94213-23-7 100mg N
diazanylidene](2,3-dichlorophenyl)acetonitrile Cl
Cl

N N H2
N
NH2
MM0922.03- Impurity C (EP): (2Z)-[2-(Diaminomethylidene)-
94213-23-7 25mg N
0025 diazanylidene](2,3-dichlorophenyl)acetonitrile Cl
Cl

H
N O
N

Impurity D (EP): 6-(2,3-Dichlorophenyl)-1,2,4- NH


MM0922.04 661463-79-2 50mg
triazine-3,5(2H,4H)-dione O
Cl
Cl

MM0922.05- Impurity E (EP): 2,3-Dichlorobenzoic Acid OH


Related compound B (USP): 2,3-dichlorobenzoic acid
50-45-3 25mg
0025 Cl
Cl

Impurity F (EP): N-[5-Amino-6-(2,3-dichlorophenyl)- N


N
H
N O

MM0922.06- 1,2,4-triazin-3-yl]-2,3-dichlorobenzamide N Cl

Related compound D (USP): N-[5-amino-6-(2,3-


252186-79-1 25mg NH2
0025 Cl Cl

dichlorophenyl)-1,2,4-triazin-3-yl]-2,3-dichlorobenzamide Cl

N NH2
Cl N
Impurity G (EP): 6-(2,4-Dichlorophenyl)-1,2,4- N
MM0922.07 38943-76-9 50mg
triazine-3,5-diamine NH2
Cl

MM0922.08- 2-(2,3-Dichlorophenyl)-2-oxoacetonitrile (2,3-


77668-42-9 25mg N
0025 Dichlorobenzoylcyanide) Cl
Cl

O
MM0922.09- Cl
2,5-Dichlorobenzoyl Cyanide 64985-85-9 25mg N
0025
Cl

O
MM0922.10-
2,4-Dichlorobenzoyl Cyanide 35022-43-6 25mg N
0025
Cl Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-334
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0922.28- N
3,4-Dichlorobenzoyl Cyanide 35022-44-7 25mg
0025 Cl
Cl

O
Cl
MM0922.29- N
3,5-Dichlorobenzoyl Cyanide 99567-74-5 25mg
0025
Cl

Lansoprazole
N F F

MM0474.00 Lansoprazole 103577-45-3 100mg N


H
S
O
F
O N

Impurity A (EP): 2-[(RS)-[[3-Methyl-1-oxido-


4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl]- N
NH

S
O
F F

F
MM0474.07 213476-12-1 100mg
sulphinyl]-1H-benzimidazole (Lansoprazole O
O
N
+

N-Oxide)
Impurity B (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoro-
ethoxy)pyridin-2-yl]methyl]sulphonyl]-1H- NH F

MM0474.01 benzimidazole (Lansoprazole Sulphone) 131926-99-3 100mg N


O
S
O
O
F
F

N
Related compound A (USP): 2-([3-Methyl-4-(2,2,2-
trifluoroethoxy)-2-pyridyl]methylsulfonyl)benzimidazole
Impurity B (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoro-
MM0474.01- ethoxy)pyridin-2-yl]methyl]sulphonyl]-1H- NH F

benzimidazole (Lansoprazole Sulphone) 131926-99-3 25mg N


O
S
O
O
F
F

N
0025 Related compound A (USP): 2-([3-Methyl-4-(2,2,2-
trifluoroethoxy)-2-pyridyl]methylsulfonyl)benzimidazole

Impurity C (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoro-


ethoxy)pyridin-2-yl]methyl]sulphanyl]-1H- NH F F

MM0474.06 benzimidazole 103577-40-8 100mg N S


O
F
N
Related compound B (USP): 2-[[[3-methyl-4-(2,2,2-
trifluoroethoxy)-pyridin-2-yl]methyl]sulfanyl]-1H-benzimidazole

Impurity C (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoro-


MM0474.06- ethoxy)pyridin-2-yl]methyl]sulphanyl]-1H- NH F F

benzimidazole 103577-40-8 25mg N S


O
F
N
0025 Related compound B (USP): 2-[[[3-methyl-4-(2,2,2-
trifluoroethoxy)-pyridin-2-yl]methyl]sulfanyl]-1H-benzimidazole

H
N
MM0474.03 Impurity D (EP): 1H-Benzimidazol-2-ol 615-16-7 100mg O
N
H

H
N
MM0474.03-
Impurity D (EP): 1H-Benzimidazol-2-ol 615-16-7 25mg O
0025 N
H

H
N
MM0474.05 Impurity E (EP): 1H-Benzimidazole-2-thiol 583-39-1 100mg SH
N

H
MM0474.05- N
Impurity E (EP): 1H-Benzimidazole-2-thiol 583-39-1 25mg SH
0025 N

Impurity F (EP): 2-[(RS)-[(4-Chloro-3-methylpyridin- NH


Cl
MM0474.02 168167-42-8 100mg N S
2-yl)methyl]sulphinyl]-1H-benzimidazole O N

MM0474.02- Impurity F (EP): 2-[(RS)-[(4-Chloro-3-methylpyridin- NH


Cl
168167-42-8 25mg N S
0025 2-yl)methyl]sulphinyl]-1H-benzimidazole O N

MM0474.04 4-Ethoxyacetophenone 1676-63-7 100mg


O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-335
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
MM0474.04-
4-Ethoxyacetophenone 1676-63-7 25mg
0025 O

NH F F

MM0474.08 Lansoprazole Sulphone N-Oxide 953787-54-7 100mg N


O
S
O N+
O
F

NH F F
MM0474.08-
Lansoprazole Sulphone N-Oxide 953787-54-7 25mg N
O
S
O N+
O
F

0025 O

F F
2-Chloromethyl-3-methyl-4-(2,2,2-trifluoro- Cl
O
F
HCl

ethoxy)pyridine Hydrochloride
MM0474.09 127337-60-4 100mg N

F F
MM0474.09- 2-Chloromethyl-3-methyl-4-(2,2,2-trifluoro- Cl
O
F
HCl
127337-60-4 25mg
0025 ethoxy)pyridine Hydrochloride N

NH F F

MM0474.11 Lansoprazole Sulfide N-Oxide 163119-30-0 100mg N S


N
+
O
F

S
O
1-Methyl-12-thioxopyrido[1',2':3,4]imidazo- N
[1,2-a]benzimidazol-2(12H)-one
MM0474.13 1246819-06-6 100mg N
N

S
O
MM0474.13- 1-Methyl-12-thioxopyrido[1',2':3,4]imidazo- N
[1,2-a]benzimidazol-2(12H)-one
1246819-06-6 25mg N
0025 N

O
+
MM0474.14- N
2,3-Dimethyl-4-nitropyridine N-Oxide 37699-43-7 25mg O
+
0025 N
O

F
F
MM0474.15- O
HO F
[3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methanol 103577-66-8 25mg
0025 N

O
MM0877.16-
2-Etoxyacetophenone 2142-67-8 100mg
0100
O

Latanoprost
O

HO
MM3316.00 Latanoprost 130209-82-4 50mg
HO
OH

O
[(3aR,4R,5R,6aS)-4-[(E,3S)-3-Hydroxy-5-phenylpent-1-enyl]- O
MM3316.05- H H

2-oxo-3,3a,4,5,6,6a-hexahydrocyclopenta[b]furan-5-yl] 4- 41639-73-0 25mg O


OH

0025 O
Phenylbenzoate
OH

O
(3aR,4R,5R,6aS)-4-[(E,3S)-3-Hydroxy-5-phenylpent-1-enyl]- H H
MM3316.06 856240-62-5 100mg
3,3a,4,5,6,6a-hexahydro-2H-cyclopenta[b]furan-2,5-diol OH
OH

OH

O
MM3316.06- (3aR,4R,5R,6aS)-4-[(E,3S)-3-Hydroxy-5-phenylpent-1-enyl]- H H
856240-62-5 25mg
0025 3,3a,4,5,6,6a-hexahydro-2H-cyclopenta[b]furan-2,5-diol OH
OH

Leachables
MM3900.02- O
Benzyl 2-Naphthyl Ether 613-62-7 100mg
0100

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-336
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Leflunomide
N
H
O N

MM0859.00 Leflunomide 75706-12-6 100mg O F

F F

Impurity A (EP) as Hydrochloride: 4-(Trifluoro- H2 N

MM0859.01 methyl)aniline Hydrochloride 90774-69-9 100mg F HCl

Related compound A (USP): 4-(trifluoromethyl)aniline F F

Impurity A (EP) as Hydrochloride: 4-(Trifluoro- H2 N


MM0859.01-
methyl)aniline Hydrochloride 90774-69-9 25mg F HCl

0025 Related compound A (USP): 4-(trifluoromethyl)aniline F F

Impurity B (EP): (2Z)-2-Cyano-3-hydroxy-N-[4- H


N
MM0859.02 (trifluoromethyl)phenyl]but-2-enamide 163451-81-8 100mg OH O F
(Teriflunomide) F F

Impurity C (EP): 5-Methyl-N-[3-(trifluoromethyl)- N


F F
phenyl]isoxazole-4-carboxamide O H
N
F
Related compound C (USP): N-(3'-Trifluoromethylphenyl)-5-
MM0859.03 61643-23-0 100mg
O

methylisoxazole-4-carboxamide
Impurity C (EP): 5-Methyl-N-[3-(trifluoromethyl)- N
F F
MM0859.03- phenyl]isoxazole-4-carboxamide O H
N
F
Related compound C (USP): N-(3'-Trifluoromethylphenyl)-5-
61643-23-0 25mg
0025 O

methylisoxazole-4-carboxamide
N
Impurity D (EP): 5-Methylisoxazole-4-carboxylic O
OH
MM0859.04 42831-50-5 100mg
Acid
O

N
Impurity D (EP): 5-Methylisoxazole-4-carboxylic O
MM0859.04- OH
42831-50-5 25mg
0025 Acid
O

N
H
MM0859.05- Impurity E (EP): 3-Methyl-N-[4-(trifluoromethyl)- O
N
208401-20-1 25mg
0025 phenyl]isoxazole-4-carboxamide O F

F F

F
F
N F
Impurity F (EP): 5-Methyl-N-[2-(trifluoromethyl)- O H
N
MM0859.06 n/a 100mg
phenyl]isoxazole-4-carboxamide
O

F
F
N F
MM0859.06- Impurity F (EP): 5-Methyl-N-[2-(trifluoromethyl)- O H
N
n/a 25mg
0025 phenyl]isoxazole-4-carboxamide
O

N
MM0859.07- Impurity G (EP): 5-Methyl-N-(4-methylphenyl)- O H
N
724429-16-7 25mg
0025 isoxazole-4-carboxamide O

H
MM0859.08- Impurity H (EP): 2-Cyano-N-[4-(trifluoromethyl)- N
24522-30-3 25mg
0025 phenyl]acetamide O F

F F

Lenalidomide
O

MM3641.00-
Lenalidomide 191732-72-6 250mg N
N
O

0250 H
NH2 O

O
MM3641.01 Methyl 2-Methyl-3-nitrobenzoate 59382-59-1 100mg
+
N
O O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-337
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
MM3641.01-
Methyl 2-Methyl-3-nitrobenzoate 59382-59-1 25mg
0025
+
N
O O

3-(4-Nitro-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-2,6- N O
MM3641.02 827026-45-9 100mg N
H
piperidinedione (4-Nitro Analogue of Lenalidomide) N
+ O
O O

MM3641.02- 3-(4-Nitro-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-2,6- N O
827026-45-9 25mg N
H
0025 piperidinedione (4-Nitro Analogue of Lenalidomide) N
+ O
O O

O
O O

MM3641.05- Dimethyl 2-(1,3-Dihydro-4-nitro-1-oxo-2H-isoindol-2-yl) N


827026-43-7 25mg O
0025 pentanedioate + O
N
O O

O
MM3641.15-
Methyl 2-(Bromomethyl)-3-nitrobenzoate 98475-07-1 25mg Br
0025
+
N
O O

Br
MM3641.16- O
Methyl 2-(Bromomethyl)-6-nitrobenzoate 61940-21-4 25mg
0025 +
N O
O O

O
MM3641.20- O
Benzyl N-(2,6-Dioxo-3-piperidyl)carbamate 24666-55-5 25mg N O
H
0025 N
H
O

Lenvatinib Mesilate
O N

H 2N
MM3934.00- O O
Lenvatinib 417716-92-8 250mg O

0250 N N
H H
Cl

Lercanidipine Hydrochloride
H
N

O O

MM3441.00 Lercanidipine Hydrochloride 132866-11-6 250mg O O


N HCl

+O
N
O

H
N

1,1-Dimethyl-2-(methylamino)ethyl Methyl (4RS)-2,6- O O


N

MM3441.01 Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5- 887769-40-6 100mg O O


H

dicarboxylate N
+O

H
N

MM3441.01- 1,1-Dimethyl-2-(methylamino)ethyl Methyl (4RS)-2,6- O O


N

Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5- 887769-40-6 25mg O O


H

0025 dicarboxylate N
+O

1,1-Dimethyl-2-[N-(3,3-diphenylpropyl)-N-methylamino]ethyl N

O O
N
MM3441.02 Methyl 2,6-Dimethyl-4-(3-nitrophenyl)pyridine-3,5- 887769-34-8 50mg O O

+O
N

dicarboxylate O

MM3441.04- O

N-Methyl-3,3-diphenylpropanamine Acetate n/a 25mg HN OH


0025
H
N

O OH
MM0092.04- 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-
74936-72-4 25mg O O
0025 dicarboxylic Acid Methyl Ester
+O
N
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-338
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

H 2N

MM0003.08 Methyl 3-Aminobut-2-enoate 14205-39-1 100mg O

H 2N
MM0003.08- O
Methyl 3-Aminobut-2-enoate 14205-39-1 25mg
0025
O

MM3441.08- 2-Methyl-1-[N-methyl-N-(3,3-diphenylpropyl)amino]propan-2-
100442-33-9 100mg HO
N
0100 ol
H
N

O O

MM0092.00 Nitrendipine 39562-70-4 500mg O O

+ O
N
O

Letrozole
N N

MM1143.00-
Letrozole 112809-51-5 250mg N
0250 N
N

Impurity A (EP): 4,4'-(4H-1,2,4-Triazol-4-ylmethylene)- N N

MM1143.02- dibenzonitrile
Related compound A (USP): 4,4'-(1H-1,3,4-triazol-1-
112809-52-6 25mg N
0025
ylmethylene)dibenzonitrile N N

N
MM1143.04-
4-(Bromomethyl)benzonitrile 17201-43-3 25mg
0025 Br

N
MM1143.05-
4-Fluorobenzonitrile 1194-02-1 25mg
0025
F

N N

MM1143.08- 4,4'-(Hydroxymethylene)dibenzonitrile (Bis-(4-Cyanophenyl)


134521-16-7 25mg
0025 methanol) OH

N N

MM1143.09-
4,4'-Carbonyldibenzonitrile (4,4'-Dicyanobenzophenone) 32446-66-5 25mg
0025 O

N N
MM1143.12-
4,4'-Methylenedibenzonitrile 10466-37-2 25mg
0025
Br Br
MM1143.14-
4,4'-Dibromobenzophenone 3988-03-2 25mg
0025 O

N
MM1143.17-
4-Methylbenzonitrile 104-85-8 100mg
0100

N
MM0235.03 1H-1,2,4-Triazole 288-88-0 100mg HN
N

N
MM0235.03-
1H-1,2,4-Triazole 288-88-0 25mg HN
0025 N

Leucine
NH2
OH
MM1470.00 Leucine (L-Leucine) 61-90-5 250mg
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-339
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Leucovorin Calcium, see Calcium Folinate

Levalbuterol Hydrochloride, see Levosalbutamol Hydrochloride

Levamisole Hydrochloride
N S

MM0706.00 Levamisole Hydrochloride 16595-80-5 100mg N


HCl

Impurity D (EP): 6-Phenyl-2,3-dihydro- N S


MM0706.04 4335-28-8 100mg
imidazo[2,1-b]thiazole N

MM0706.04- Impurity D (EP): 6-Phenyl-2,3-dihydro- N S


4335-28-8 25mg
0025 imidazo[2,1-b]thiazole N

Levetiracetam
O
MM1372.00- N
Levetiracetam 102767-28-2 250mg N H2
0250 O

O
N
MM1372.01 Impurity A (EP): (2RS)-2-(2-Oxopyrrolidin-1-yl)butanoic Acid 67118-31-4 100mg OH
O

O
MM1372.01- N
Impurity A (EP): (2RS)-2-(2-Oxopyrrolidin-1-yl)butanoic Acid 67118-31-4 25mg OH
0025 O

O
MM1372.02- N
Impurity B (EP): (2Z)-2-(2-Oxopyrrolidin-1-yl)but-2-enamide 358629-47-7 25mg N H2
0025 O

N
MM1372.03 Impurity C (EP): Pyridin-2-ol 72762-00-6 100mg
OH

MM1372.03- N
Impurity C (EP): Pyridin-2-ol 72762-00-6 25mg
0025 OH

O
MM1372.04- Impurity D (EP): (2R)-2-(2-Oxopyrrolidin-1-yl)butanamide N
103765-01-1 25mg N H2
0025 ((R)-Etiracetam) O

NH2
MM1372.10-
Impurity E (EP): (1R)-1-Phenylethan-1-amine 3886-69-9 100mg
0100

Impurity G (EP) as Hydrochloride: (2S)-2-Aminobutanamide O


MM1372.05- H2 N
Hydrochloride ((S)-2-Aminobutanamide Hydrochloride) 7682-20-4 25mg NH2 HCl
0025
Related compound B (USP): (S)-2-aminobutanamide
(S)-N-(1-Amino-1-oxobutan-2-yl)-4-chlorobutanamide O
H
MM1372.06- N
Cl NH2
Related compound A (USP): (S)-N-(1-amino-1-oxobutan-2- 102767-31-7 25mg O
0025
yl)-4-chlorobutanamide

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-340
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
MM1372.07- H 2N
(S)-2-Aminobutanoic Acid 1492-24-6 100mg OH
0100

H
N O
MM0083.05 Pyrrolidin-2-one (2-Pyrrolidone) 616-45-5 100mg

O
MM0083.00- N
Piracetam 7491-74-9 250mg N H2
0250 O

N H2 O
H
MM1372.11- N
1867585-44-1 25mg NH2
(2R)-2-[(2R)-2-Aminobutanamido]butanamide
0025 O

Levocarnitine
MM0759.00- + O
Levocarnitine 541-15-1 250mg N
0250 OH O

Impurity A (EP) as Hydrochloride: (2EZ)-4- OH


+
N Cl
MM0759.01 (Trimethylazaniumyl)but-2-enoic Acid Chloride 6538-82-5 100mg O

(Crotonobetaine Hydrochloride)

Levocetirizine Dihydrochloride
O
Cl O
N OH
MM1035.00-
Levocetirizine Dihydrochloride 130018-87-0 250mg
N HCl
2

0250
Cl
NH
N

MM1035.01 (R)-1-[(4-Chlorophenyl)phenylmethyl]piperazine 300543-56-0 100mg

Cl
NH
N
MM1035.01-
(R)-1-[(4-Chlorophenyl)phenylmethyl]piperazine 300543-56-0 25mg
0025

Cl

N H2
MM1035.02-
(R)-(4-Chlorophenyl)phenylmethanamine 163837-57-8 100mg
0100

O
Cl O
N O
N

MM1035.04 Levocetirizine Ethyl Ester 1116338-10-3 100mg


O
Cl O
N O
N

MM1035.05 Levocetirizine Isopropyl Ester n/a 100mg

O O
S Cl
MM1035.10- N
N,N-Bis(2-chloroethyl)-p-toluenesulfonamide 42137-88-2 25mg
0025
Cl

Levodopa
O

OH
MM0262.00 Levodopa 59-92-7 500mg N H2
HO
OH

HO
N H2
MM0634.00- Impurity B (EP): (2S)-2-Amino-3-(4-hydroxyphenyl)propanoic OH
60-18-4 250mg
0250 Acid (Tyrosine) O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-341
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity C (EP): (2RS)-2-Amino-3-(4-hydroxy-3- O

MM0262.05- methoxyphenyl)propanoic Acid (3-Methoxy- OH


NH2
DL-tyrosine; (DL)-3-O-Methyldopa)
7636-26-2 25mg HO
0025
O
Related compound B (USP): 3-methoxytyrosine

O
MM0262.01 1-(3,4-Dihydroxyphenyl)propan-2-one 2503-44-8 50mg HO
OH

OH
OH

MM0262.06 4-Hydroxy-3-methoxymandelic Acid 55-10-7 100mg HO


O

OH
OH
MM0262.06-
4-Hydroxy-3-methoxymandelic Acid 55-10-7 25mg HO
O
0025
O

O
MM0262.09- O
3,4-Methylenedioxybenzaldehyde (Piperonal) 120-57-0 100mg
0100
O

MM0262.16 N,N-Dimethyl-L-phenylalanine 17469-89-5 100mg OH


N

O
MM0262.16-
N,N-Dimethyl-L-phenylalanine 17469-89-5 25mg OH
0025 N

O
MM0262.17- O
OH
(2S)-2-Amino-3-(3-methoxyphenyl)propanoic Acid 33879-32-2 25mg
0025 NH2

O
HCl
MM0262.18 Levodopa Methyl Ester Hydrochloride 1421-65-4 100mg N H2
HO
OH

MM0262.18- O
HCl
Levodopa Methyl Ester Hydrochloride 1421-65-4 25mg N H2
HO
0025 OH

O
MM0262.20 Levodopa Isopropyl Ester 110301-07-0 100mg NH2
HO
OH

MM0262.20- O
Levodopa Isopropyl Ester 110301-07-0 25mg NH2
HO
0025 OH

Levodropropizine
N OH

MM1246.00 Levodropropizine 99291-25-5 250mg N OH

NH
Impurity B (EP) as Hydrochloride: 1-Phenyl- N HCl
MM1246.02 2210-93-7 100mg
piperazine Hydrochloride

NH
MM1246.02- Impurity B (EP) as Hydrochloride: 1-Phenyl- N HCl
2210-93-7 25mg
0025 piperazine Hydrochloride
O
+
N OH

MM1246.05 Levodropropizine N-Oxide 152237-40-6 100mg N OH

O
+
N OH
MM1246.05-
Levodropropizine N-Oxide 152237-40-6 25mg N OH

0025

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-342
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Levofloxacin Hemihydrate
N O
N N

MM0846.00 Levofloxacin 100986-85-4 100mg OH


F
O O

Impurity B (EP): (3S)-9-Fluoro-3-methyl-7-oxo-10-(piperazin-


1-yl)-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-
HN O

MM0846.02- carboxylic Acid (N-Desmethyllevofloxacin) N N

117707-40-1 25mg F
OH
0025 Related compound A (USP): (S)-9-fluoro-3-methyl-10- O O

(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]
benzoxazine-6-carboxylic acid
O
Impurity C (EP): 4-[(3S)-6-Carboxy-9-fluoro-3-methyl-7-oxo- +
N O
MM0846.03- N N
2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazin-10-yl]-1- 117678-38-3 25mg OH
0025 F
methylpiperazine 1-Oxide (Levofloxacin N-Oxide) O O

Impurity F (EP): (3S)-9,10-Difluoro-3-methyl-7-oxo-2,3-


dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic
O
Acid ((S)-9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido F N
MM0846.01-
[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid) 100986-89-8 25mg OH
0025 F
Related compound B (USP): (S)-9,10,difluoro-3-methyl-7- O O

oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-
carboxylic acid
Impurity G (EP) as Hydrochloride: (3S)-9-Fluoro-3-methyl-10-
[[2-(methylamino)ethyl]amino]-7-oxo-2,3-dihydro-7H-pyrido
O
H
MM0846.11- [1,2,3-de][1,4]benzoxazine-6-carboxylic Acid Hydrochloride N N
N HCl
H
1346603-62-0 25mg F
OH

0025 Related compound E (USP): (S)-9-Fluoro-2,3-dihydro-3- O O

methyl-10-[2-(methylamino)ethylamino]-7-oxo-7H-pyrido
[1,2,3-de][1,4]benzoxazine-6-carboxylic acid
Impurity H (EP): Ethyl (3S)-9-Fluoro-3-methyl-10-(4-
methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]
N O

MM0846.05- [1,4]benzoxazine-6-carboxylate (Levofloxacin Ethyl Ester) N N

177472-30-9 25mg F
O
0025 Related compound C (USP): (S)-ethyl 9-fluoro-2,3-dihydro-3- O O

methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-
1,4-benzoxazine-6-carboxylate
N O
N N

MM0846.06 Levofloxacin Methyl Ester 862690-19-5 100mg F


O

O O

N O

MM0846.06- N N

Levofloxacin Methyl Ester 862690-19-5 25mg F


O
0025 O O

N O
N N

MM0846.07 Levofloxacin Isopropyl Ester n/a 100mg F


O

O O

N O

MM0846.07- N N

Levofloxacin Isopropyl Ester n/a 25mg F


O
0025 O O

OH

N F
MM0846.13- (1S)-6,8-Difluoro-1-[2-hydroxy-1-methylethyl]-7-(4- N N
1036016-10-0 25mg OH
0025 methylpiperazin-1-yl)-4-oxoquinoline-3-carboxylic Acid F
O O

MM0846.14- (S)-9,10-Difluoro-2,3-dihydro-3-methyl-7-oxo-7H-pyrido[1,2,3- F N

106939-34-8 25mg O
0025 de]-1,4-benzoxazine-6-carboxylic Acid Ethyl Ester F
O O

Levomenthol
OH

MM0388.00 Levomenthol 2216-51-5 500mg

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-343
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Levomepromazine Hydrochloride

N N
MM0266.00 Levomepromazine Hydrochloride 1236-99-3 500mg S
HCl

Levomepromazine Maleate
O

N N OH
MM0019.00 Levomepromazine Maleate 7104-38-3 100mg S OH

O
O

NH
MM0019.02 Impurity A (EP): 2-Methoxyphenothiazine 1771-18-2 100mg S

MM0019.02- NH
Impurity A (EP): 2-Methoxyphenothiazine 1771-18-2 25mg S
0025
O

Impurity B (EP): 10-[(2R)-3-(Dimethylamino)-2- N N


MM0019.01 methylpropyl]-2-methoxy-10H-phenothiazine 7606-29-3 100mg O
S

5-Oxide (Levomepromazine S-Oxide)


O

MM0019.01- Impurity B (EP): 10-[(2R)-3-(Dimethylamino)-2- N N


methylpropyl]-2-methoxy-10H-phenothiazine 7606-29-3 25mg O
S
0025 5-Oxide (Levomepromazine S-Oxide)
O

MM1439.00- OH
Maleic Acid 110-16-7 250mg
0250 OH

N N
MM0019.05 O-Desmethyllevomepromazine 81607-63-8 100mg S

OH

MM0019.05- N N
O-Desmethyllevomepromazine 81607-63-8 25mg S
0025
OH

N N
MM0019.07 N-Demethyllevomepromazine Hydrochloride 61733-92-4 100mg S
H HCl

MM0019.07- N N
N-Demethyllevomepromazine Hydrochloride 61733-92-4 25mg S
H HCl

0025
O

N N
MM0019.09 Levomepromazine Sulphone Hydrochloride 60119-90-6 100mg O S
HCl

O
O

MM0019.09- N N
Levomepromazine Sulphone Hydrochloride 60119-90-6 25mg O S
HCl

0025 O
O

+
MM0019.11- Levomepromazine Sulfone N-Oxide (Levomepromazine N N
2724689-26-1 25mg O S O
0025 N,S,S-Trioxide) O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-344
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Levonorgestrel
OH

MM0121.00 Levonorgestrel 797-63-7 250mg H H

H H
O

OH

Impurity G (EP): 13-Ethyl-6 ,17-dihydroxy-18,19-dinor-17 - H H

MM0121.08 87585-03-3 50mg


pregn-4-en-20-yn-3-one (6 -Hydroxylevonorgestrel) O
H H

OH

OH

Impurity H (EP): 13-Ethyl-6 ,17-dihydroxy-18,19-dinor-17 - H H

MM0121.01 55555-97-0 100mg


pregn-4-en-20-yn-3-one (6 -Hydroxylevonorgestrel) O
H H

OH

OH

MM0121.01- Impurity H (EP): 13-Ethyl-6 ,17-dihydroxy-18,19-dinor-17 - H H

55555-97-0 25mg
0025 pregn-4-en-20-yn-3-one (6 -Hydroxylevonorgestrel) O
H H

OH

OH

Impurity J (EP): 13-Ethyl-17-hydroxy-18,19-dinor-17 -pregn- H H

MM0121.02 4-en-20-yn-3,6-dione (6-Oxolevonorgestrel; 6- 1175109-63-3 100mg H H

Ketolevonorgestrel) O
O

OH

MM0121.02- Impurity J (EP): 13-Ethyl-17-hydroxy-18,19-dinor-17 -pregn- H H

4-en-20-yn-3,6-dione (6-Oxolevonorgestrel; 6- 1175109-63-3 25mg H H


0025 Ketolevonorgestrel) O
O

Impurity L (EP): 13-Ethylgon-4-ene-3,17-dione (Levodione; H H


MM0121.12 21800-83-9 100mg
18-Methyl-19-norandrost-4-ene-3,17-dione) H H
O

MM0121.12- Impurity L (EP): 13-Ethylgon-4-ene-3,17-dione (Levodione; H H


21800-83-9 25mg
0025 18-Methyl-19-norandrost-4-ene-3,17-dione) H H
O

OH
Impurity M (EP): 13-Ethyl-17-hydroxy-18,19-dinor-17 -
H H
MM0121.11 pregna-4,6-dien-20-yn-3-one ( 6-Levonorgestrel; 6,7- 51087-61-7 100mg
H H
Didehydrolevonorgestrel) O

OH

Impurity U (EP): 17-Hydroxy-19-nor-17 -pregn-4-en-20-yn-3- H H


MM0218.00 68-22-4 250mg
one (Norethisterone) H H
O

OH

MM0121.13- 13 -Ethyl-18,19-dinor-17 -pregna-1,3,5(10)-trien-20-yne- H


14012-72-7 25mg H H
0025 3,17-diol (A-Aromate-Levonorgestrel) HO

Levosalbutamol Hydrochloride (Levalbuterol Hydrochloride)


OH

MM0381.09- (1RS)-2-[(1,1-Dimethylethyl)amino]-1-[4-(benzyloxy)-3- H
N

(hydroxymethyl)phenyl]ethanol 56796-66-8 25mg O


0025 Related compound F (USP): alpha-[(1,1-Dimethylethyl) OH

(1RS)-2-[(1,1-Dimethylethyl)amino]-1-[4-hydroxy-3-
OH
H
(methoxymethyl)phenyl]ethanol N
MM0381.18-
Related compound C (USP): alpha-[(1,1-Dimethylethyl) 18910-70-8 25mg HO
0025
aminomethyl]-4-hydroxy-3-(methoxymethyl)- O

benzenemethanol
OH
H
N
MM3403.02- -[[(1,1-Dimethylethyl)amino]methyl]-2,2-dimethyl-4H-1,3-
54208-72-9 25mg O
0025 benzodioxin-6-methanol (Salbutamol Acetonide)
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-345
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N -[[(1,1-Dimethylethyl)(phenylmethyl)amino]methyl]-2,2- OH
MM3403.03- N
e dimethyl-4H-1,3-benzodioxin-6-methanol (N- 1797114-57-8 25mg
0025 O
w Benzylsalbutamol Acetonide) O

Levosimendan
H
N N N
H
MM3946.00- O N
Levosimendan 141505-33-1 250mg N

0250 N

Levosulpiride
O O O
N
MM0941.00 Levosulpiride 23672-07-3 250mg H2 N
S
N
H
O

Levothyroxine Sodium
I

MM0694.00- I O

Levothyroxine Sodium
NH2
+
25416-65-3 100mg O Na H2 O
HO I
I O
0100
I
O
Impurity C (EP): [4-(4-Hydroxy-3-iodophenoxy)-3,5- O
MM0626.04 51-24-1 100mg HO I OH
diiodophenyl]acetic Acid (Triiodothyroacetic Acid) I

I
I O
Impurity D (EP): [4-(4-Hydroxy-3,5-diiodophenoxy)-3,5- O
MM0626.05 67-30-1 100mg HO I OH
diiodophenyl]acetic Acid (Tetraiodothyroacetic Acid) I

I
I O
MM0626.05- Impurity D (EP): [4-(4-Hydroxy-3,5-diiodophenoxy)-3,5- O
67-30-1 25mg HO I OH
0025 diiodophenyl]acetic Acid (Tetraiodothyroacetic Acid) I

MM0694.10- Imp K (EP): (2S)-2-Amino-3-[4-(4-hydroxy-3,5-)-3- I O


I

NH2
iodophenyl]propanoic Acid 5817-39-0 25mg HO
OH

0025 (3,3',5'-Triiodo-L-Thyronine) I O

I O
I O
HN
MM0694.12 N-Acetyl-L-Thyroxine (N-Acetyllevothyroxine) 26041-51-0 100mg OH
HO I
I O

I O
I O
MM0694.12- HN
N-Acetyl-L-Thyroxine (N-Acetyllevothyroxine) 26041-51-0 25mg OH
HO I
0025 I O

I
HO

MM0694.14 3,5-Diiodo-4-hydroxybenzoic Acid 618-76-8 100mg OH


I
O

I
HO
MM0694.14-
3,5-Diiodo-4-hydroxybenzoic Acid 618-76-8 25mg OH
0025 I
O

I
I O
MM0694.16- 4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodobenzoic Acid (3,3',5-
4618-45-5 25mg OH
HO I
0025 Triiodothyroformic Acid) O

I
I O
MM0694.17- 2-[4-(4-Hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl] O
176258-88-1 25mg HO I N H2
0025 acetamide (3,3',5,5'-Tetraiodothyroacetamide) I

I
MM0694.18- OH
2,6-Diiodophenol 28177-54-0 25mg
0025
I

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-346
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Lidocaine Hydrochloride Monohydrate


H HCl
MM0102.04- N
Lidocaine Hydrochloride Monohydrate 6108-05-0 250mg O
N
H2 O
0250
H
MM0102.00- N
Lidocaine 137-58-6 250mg N

0250 O

N H2
MM0102.02 Impurity A (EP): 2,6-Dimethylaniline 87-62-7 100mg

MM0102.15- Impurity A (EP) as Hydrochloride: 2,6-Dimethylaniline N H2


HCl
21436-98-6 25mg
0025 Hydrochloride

Impurity B (EP): 2-(Diethylazinoyl)-N-(2,6- H


N
O
+
MM0102.01 dimethylphenyl)acetamide (Lidocaine N2- 2903-45-9 100mg N
O
Oxide)

MM0102.01- Impurity B (EP): 2-(Diethylazinoyl)-N-(2,6- H


N
O
+
dimethylphenyl)acetamide (Lidocaine N2- 2903-45-9 25mg N
O
0025 Oxide)
H
Impurity C (EP): N-(2,6-Dimethylphenyl)- N
MM0102.08 2198-53-0 100mg
acetamide O

H
MM0102.08- Impurity C (EP): N-(2,6-Dimethylphenyl)- N
2198-53-0 25mg
0025 acetamide O

Impurity D (EP) as Hydrochloride: N-(2,6-


Dimethylphenyl)-2-(ethylamino)acetamide H
N
N HCl
MM0102.05 7729-94-4 100mg H
Hydrochloride (Monoethylglycinexylidide O

Hydrochloride)
Impurity D (EP) as Hydrochloride: N-(2,6-
MM0102.05- Dimethylphenyl)-2-(ethylamino)acetamide H
N
N HCl
7729-94-4 25mg H
0025 Hydrochloride (Monoethylglycinexylidide O

Hydrochloride)
Impurity E (EP) as Hydrochloride: 2,2'- H H
N N

MM0102.09 (Azanediyl)bis[N-(2,6-dimethylphenyl)- 1135231-62-7 100mg O


N
H
O
HCl

acetamide] Hydrochloride

MM0102.09- Impurity E (EP) as Hydrochloride: 2,2'- H H


N N

(Azanediyl)bis[N-(2,6-dimethylphenyl)- 1135231-62-7 25mg O


N
H
O
HCl

0025 acetamide] Hydrochloride


H

Impurity F (EP) as Hydrochloride: 2-(Diethylamino)-N-(2,3- N


N

MM0102.10 857170-72-0 100mg O HCl


dimethylphenyl)acetamide Hydrochloride
H
MM0102.10- Impurity F (EP) as Hydrochloride: 2-(Diethylamino)-N-(2,3- N
N

857170-72-0 25mg O HCl

0025 dimethylphenyl)acetamide Hydrochloride

Impurity G (EP) as Hydrochloride: N-(2,6- H


N
MM0102.11 Dimethylphenyl)-2-[(1-methylethyl)amino]- 35891-87-3 100mg O
N
H
HCl

acetamide Hydrochloride
Impurity G (EP) as Hydrochloride: N-(2,6- H
MM0102.11- N
Dimethylphenyl)-2-[(1-methylethyl)amino]- 35891-87-3 25mg O
N
H
HCl

0025 acetamide Hydrochloride


Impurity H (EP): 2-Chloro-N-(2,6-dimethylphenyl)- H
acetamide N
Cl
MM0102.03
Related compound H (USP): 2-Chloro-N-(2,6-
1131-01-7 100mg
O
dimethylphenyl)acetamide

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-347
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity H (EP): 2-Chloro-N-(2,6-dimethylphenyl)- H


MM0102.03- acetamide N
Cl
Related compound H (USP): 2-Chloro-N-(2,6-
1131-01-7 25mg
0025 O
dimethylphenyl)acetamide
MM0102.12- Impurity I (EP) as Hydrochloride: 2-(Diethylamino)- H
N
N HCl
17289-54-2 25mg
0025 N-(2,4-dimethylphenyl)acetamide Hydrochloride O

MM0102.13- Impurity J (EP) as Hydrochloride: 2-(Diethylamino)- H


N
N HCl
1012864-23-1 25mg
0025 N-(2,5-dimethylphenyl)acetamide Hydrochloride O

Impurity K (EP) as Hydrochloride: N-(2,6-Dimethyl- H


N
MM0102.14 phenyl)-2-(ethylmethylamino)acetamide Hydro- 50295-20-0 100mg O
N HCl

chloride
Impurity K (EP) as Hydrochloride: N-(2,6-Dimethyl- H
MM0102.14- N
phenyl)-2-(ethylmethylamino)acetamide Hydro- 50295-20-0 25mg O
N HCl

0025 chloride
H
N
N H2
MM0102.17 Glycinexylidide (2-Amino-N-(2,6-dimethylphenyl)acetamide) 18865-38-8 100mg
O

H
MM0102.17- N
N H2
Glycinexylidide (2-Amino-N-(2,6-dimethylphenyl)acetamide) 18865-38-8 25mg
0025 O

Cl
H
N
MM0102.18 2,2-Dichloro-N-(2,6-dimethylphenyl)acetamide 39084-88-3 100mg Cl
O

Cl
H
MM0102.18- N
2,2-Dichloro-N-(2,6-dimethylphenyl)acetamide 39084-88-3 25mg Cl
0025 O

Lidoflazine
F

Lidoflazine
N
N
MM3120.00 3416-26-0 50mg N O

Linagliptin
O
N N

MM3412.00 Linagliptin 668270-12-0 250mg N


O
N

N N
N

NH2

Lincomycin Hydrochloride
N OH
H
N

HCl H2O
O H O
MM0320.00 Lincomycin Hydrochloride Monohydrate 7179-49-9 250mg HO S

HO OH

Lindane
Cl
Cl Cl

MM0755.00 Lindane 58-89-9 250mg


Cl Cl
Cl

Linezolid
O H
O N
O
N

MM3300.00 Linezolid 165800-03-3 250mg N


O F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-348
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

(S)-5-(Aminomethyl)-3-(3-fluoro-4-morpholinophenyl) O
N
MM3300.01- oxazolidin-2-one (Desacetyllinezolid) O

168828-90-8 25mg F N
O
0025 Related compound C (USP): (S)-5-(aminomethyl)-3-(3-
NH2
fluoro-4-morpholinophenyl)oxazolidin-2-one
(R)-5-(Azidomethyl)-3-(3-fluoro-4-morpholinophenyl) O
N
MM3300.02- oxazolidin-2-one O

168828-84-0 25mg F N
O
0025 Related compound A (USP): (R)-5-(azidomethyl)-3-(3-fluoro- +
N N N

4-morpholinophenyl)oxazolidin-2-one
O
(S)-N-[[3-(3-Fluoro-4-morpholinophenyl)-2-oxooxazolidin-5-yl] N
O
MM3300.03- methyl]thioacetamide F N
O
216868-57-4 25mg
0025 Related compound B (USP): (S)-N-[3-(3-fluoro-4- H
N

morpholinophenyl)-2-oxooxazolidin-5-yl]methylthioacetamide S

O
+
N
O
O
F N
O
MM3300.04 Linezolid N-Oxide 189038-36-6 100mg
H
N

O
+
N
O
O
MM3300.04- F N
O
Linezolid N-Oxide 189038-36-6 25mg
0025 H
N

O
N
(5R)-3-(3-Fluoro-4-morpholinophenyl)-5-(hydroxymethyl) O
MM3300.05 168828-82-8 100mg F N
O
oxazolidin-2-one
OH

O
N
MM3300.05- (5R)-3-(3-Fluoro-4-morpholinophenyl)-5-(hydroxymethyl) O
168828-82-8 25mg F N
O
0025 oxazolidin-2-one
OH

(5R)-[3-(3-Fluoro-4-morpholinophenyl)-2-oxooxazolidin-5-yl] O
N
methyl Methanesulfonate O
MM3300.06- F N
O
Related compound D (USP): (R)-[3-(3-Fluoro-4- 174649-09-3 25mg
0025 O
O S
morpholinophenyl)-2-oxooxazolidin-5-yl]methyl
O

methanesulfonate
O
N
O
MM3300.07- F N
O
(R)-Linezolid 872992-20-6 25mg
0025 H
N

O
N
(5R)-5-(Chloromethyl)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2- O
MM3300.08 496031-57-3 100mg F N
O
oxazolidinone
Cl

O
N
MM3300.08- (5R)-5-(Chloromethyl)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2- O
496031-57-3 25mg F N
O
0025 oxazolidinone
Cl

O
N
O
2-[[(5S)-3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5- F N
O O
MM3300.09 168828-89-5 100mg
oxazolidinyl]methyl]-1H-isoindole-1,3(2H)-dione N

O
N
O
MM3300.09- 2-[[(5S)-3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5- F N
O O
168828-89-5 25mg
0025 oxazolidinyl]methyl]-1H-isoindole-1,3(2H)-dione N

O
N
O
MM3300.10- N
O
Desfluorolinezolid 556801-15-1 25mg
0025 H
N

O
N
MM3300.12- N-[(2S)-3-Amino-2-hydroxypropyl]-N-(3-fluoro-4- HCl
1391068-25-9 25mg F N NH2
0025 morpholinophenyl)acetamide Hydrochloride O
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-349
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
N
O
MM3300.13- (5R)-[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5- F N
O
496031-56-2 25mg
0025 oxazolidinyl]methyl Acetate O

O
N

MM3300.16- N-[(2R)-3-(3-Fluoro-4-morpholinoanilino)-2-hydroxypropyl] F NH
333753-67-6 25mg OH
0025 acetamide
NH

O
N
O
MM3300.18 Benzyl 3-Fluoro-4-(4-morpholinyl)phenylcarbamate 168828-81-7 100mg F N O
H

O
N
MM3300.18- O
Benzyl 3-Fluoro-4-(4-morpholinyl)phenylcarbamate 168828-81-7 25mg F N O
0025 H

O
N
O
MM3300.19- (5S)-5-[[(1,1-Dimethylethyl)amino]methyl]-3-[3-fluoro-4-(4- F N O
1215006-08-8 25mg
0025 morpholinyl)phenyl]-2-oxazolidinone H
N

O
N
O
MM3300.20- N-(1,1-Dimethylethyl)-N-[[(5S)-3-[3-fluoro-4-(4-morpholinyl) F N O O
1215006-11-3 25mg
0025 phenyl]-2-oxo-5-oxazolidinyl]methyl]acetamide N

O
N
MM3300.24- N-(3-Phthalimido-2-(R)-hydroxypropyl)-3-fluoro-4-(4- O

874340-08-6 25mg F N
H
N

0025 OH
morpholinyl)aniline O

MM3300.23- O N N H2
3-Fluoro-4-(4-morpholinyl)aniline 93246-53-8 25mg
0025 F

Liothyronine Sodium
I
O

Liothyronine Sodium
N H2
MM0626.00 55-06-1 50mg O +
HO I Na
I O

Impurity C (EP): [4-(4-Hydroxy-3-iodophenoxy)-3,5- O


O
MM0626.04 51-24-1 100mg
diiodophenyl]acetic Acid (Triiodothyroacetic Acid) HO
I
I OH

Impurity D (EP): [4-(4-Hydroxy-3,5-diiodophenoxy)- I O


I

O
MM0626.05 3,5-diiodophenyl]acetic Acid (Tetraiodothyroacetic 67-30-1 100mg HO I OH

Acid) I

MM0626.05- Impurity D (EP): [4-(4-Hydroxy-3,5-diiodophenoxy)- I O


I

O
3,5-diiodophenyl]acetic Acid (Tetraiodothyroacetic 67-30-1 25mg HO I OH
0025 Acid) I

Impurity E (EP): (2S)-2-Amino-3-[4-(4-hydroxyphenoxy)-3,5- O


NH2
MM0626.08 1041-01-6 100mg OH

diiodophenyl]propanoic Acid (Diiodothyronine) HO I


O

MM0626.08- Impurity E (EP): (2S)-2-Amino-3-[4-(4-hydroxyphenoxy)-3,5- O


NH2
1041-01-6 25mg OH

0025 diiodophenyl]propanoic Acid (Diiodothyronine) HO I


O

I
O
N H2
MM0626.09 Liothyronine Methyl Ester 54914-53-3 100mg O
HO I
I O

I
O
MM0626.09- N H2
Liothyronine Methyl Ester 54914-53-3 25mg O
HO I
0025 I O

I
O
MM0626.10- N H2

Liothyronine Ethyl Ester 3005-97-8 25mg O


HO I
0025 I O

I
O
MM0626.11- N H2

Liothyronine Isopropyl Ester 2732347-43-0 25mg O


HO I
0025 I O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-350
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Alpha Lipoic Acid, see Thioctic Acid

Lisdexamfetamine Dimesilate
N H2
MM1521.00- O H HCl
Lysine Hydrochloride (L-Lysine Hydrochloride) 657-27-2 250mg H2 N

0250 O

O
MM3626.01- O
HN O
N,N'-Bis(benzyloxycarbonyl)-L-lysine 405-39-0 25mg HO
0025 N O
H
O

O
2,5-Dioxopyrrolidin-1-yl (2S)-2,6-Bis(tert-
MM3626.03- O HN O O
O
butoxycarbonylamino)hexanoate (N,N'-Bis(tert- 30189-36-7 25mg N N O
H
O
0025 O
butoxycarbonyl)-L-lysine N-Succinimidyl Ester)
2,5-Dioxopyrrolidin-1-yl (2S)-2,6-Bis O
MM3626.04- O HN O O
(benzyloxycarbonylamino)hexanoate (N,N'-Bis 21160-83-8 25mg N
O
N O
0025 H
O
O
(benzyloxycarbonyl)-L-lysine N-Succinimidyl Ester)

Lisinopril Dihydrate
O
O OH
H
N
N
MM0598.00 Lisinopril Dihydrate 83915-83-7 100mg HO O
H2O
2 H 2N

Impurity A (EP): (2RS)-2-Amino-4-phenylbutanoic N H2


MM0598.01 1012-05-1 100mg
Acid
HO O

MM0598.01- Impurity A (EP): (2RS)-2-Amino-4-phenylbutanoic N H2


1012-05-1 25mg
0025 Acid
HO O

O O
Impurity B (EP) as Hydrate: 4-Methylbenzene- S
OH H2O
MM0598.02 6192-52-5 100mg
sulphonic Acid Hydrate
Impurity C (EP): (2S)-2-[(3S,8aS)-3-(4-Aminobutyl)-
H
1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)- O
N
yl]-4-phenylbutanoic Acid (S,S,S-Diketopiperazine) N
O
MM0598.03
Related compound A (USP): (S)-2-(3S,8aS)-3-(4-
328385-86-0 25mg
HO O

aminobutyl)-1,4-dioxohexahydropyrrolo[1,2-alpha]pyrazin-2 H 2N

(1H)-yl-4-phenylbutanoic acid
H
O
Impurity D (EP): (2S)-2-[(3S,8aR)-3-(4-Aminobutyl)- N
N
MM0598.04 1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)- 219677-82-4 100mg O

yl]-4-phenylbutanoic Acid (R,S,S-Diketopiperazine) HO


H 2N
O

H
O
Impurity D (EP): (2S)-2-[(3S,8aR)-3-(4-Aminobutyl)- N
MM0598.04- N
1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)- 219677-82-4 25mg O

0025 yl]-4-phenylbutanoic Acid (R,S,S-Diketopiperazine) HO


H 2N
O

O
N H
Impurity H (EP): (2S)-6-Amino-2-[[(1S)-1-carboxy-3- N
MM0598.07- OH
e 138247-43-5 25mg HO O
w
0025 phenylpropyl]amino]hexanoic Acid H 2N

MM0598.09- O
2-Oxo-4-phenylbutanoic Acid 710-11-2 25mg
0025
HO O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-351
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
H
O N
OH
MM0598.10- O
N2-(Benzyloxycarbonyl)-N6-(tert-butoxycarbonyl)-L-lysine 2389-60-8 25mg H
0025 O N

Lobeline Hydrochloride

MM3423.00 Lobeline Hydrochloride 134-63-4 250mg OH


N

O
HCl

Lofepramine Hydrochloride
HCl Cl

MM3119.00 Lofepramine Hydrochloride 26786-32-3 250mg


N N
O

Lofexidine Hydrochloride
Cl N
O
MM1898.00 Lofexidine Hydrochloride 21498-08-8 100mg N
H
HCl

Cl

Lomefloxacin Hydrochloride
HN F
HCl
N N

MM0841.00 Lomefloxacin Hydrochloride 98079-52-8 100mg OH


F
O O

Lomustine
O
MM0923.01-
Impurity A (EP): 1,3-Bis(2-chloroethyl)urea 2214-72-4 25mg Cl
N N
Cl

0025 H H

Impurity B (EP): 1-(2-Chloroethyl)-3-cyclohexylurea O

MM0923.02 Related compound B (USP): 1-(2-Chloroethyl)-3- 13908-11-7 100mg N N


Cl
H H
cyclohexylurea
Impurity B (EP): 1-(2-Chloroethyl)-3-cyclohexylurea O
MM0923.02-
Related compound B (USP): 1-(2-Chloroethyl)-3- 13908-11-7 25mg N N
Cl
H H
0025 cyclohexylurea
Impurity C (EP): 1,3-Dicyclohexylurea O

Related compound C (USP): 1,3-Dicyclohexylurea


MM0923.03 2387-23-7 100mg N N
H H

MM0923.03- Impurity C (EP): 1,3-Dicyclohexylurea O

2387-23-7 25mg
0025 Related compound C (USP): 1,3-Dicyclohexylurea N
H
N
H

Loperamide Hydrochloride
OH

N
N

MM0025.00 Loperamide Hydrochloride 34552-83-5 500mg Cl


O
HCl

Cl

OH

MM0025.14- Impurity A (EP): 4-[4-(4'-Chlorobiphenyl-4-yl)-4-


hydroxypiperidin-1-yl]-N,N-dimethyl-2,2- 1391052-94-0 25mg N

0025 diphenylbutanamide N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-352
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N O

OH Br
Impurity B (EP) as Bromide: 4-(4-Chlorophenyl)- +
N
MM0025.15 1,1-bis[4-(dimethylamino)-4-oxo-3,3-diphenyl- 2575516-63-9 100mg Cl

butyl]-4-hydroxypiperidinium Bromide N

N O

OH Br

MM0025.15- Impurity B (EP) as Bromide: 4-(4-Chlorophenyl)- +


N
1,1-bis[4-(dimethylamino)-4-oxo-3,3-diphenyl- 2575516-63-9 25mg Cl
0025 butyl]-4-hydroxypiperidinium Bromide N

Cl

OH
MM0025.04 Impurity C (EP): 4-(4-Chlorophenyl)piperidin-4-ol 39512-49-7 100mg
N
H

Cl

OH
MM0025.04-
Impurity C (EP): 4-(4-Chlorophenyl)piperidin-4-ol 39512-49-7 25mg
0025
N
H

OH

N
Impurity D (EP): 4-(4-Hydroxy-4-phenylpiperidin-
MM0025.05 37743-41-2 100mg
1-yl)-N,N-dimethyl-2,2-diphenylbutanamide
N

OH

N
MM0025.05- Impurity D (EP): 4-(4-Hydroxy-4-phenylpiperidin-
37743-41-2 25mg
0025 1-yl)-N,N-dimethyl-2,2-diphenylbutanamide
N

Cl

OH

MM0025.16- Impurity E (EP): 4-(4-Chlorophenyl)-1-[4-[4-(4-chlorophenyl)- N


OH
1426322-82-8 25mg
0025 4-hydroxypiperidin-1-yl]-2,2-diphenylbutanoyl]piperidin-4-ol N
Cl
O

Cl
OH

Impurity F (EP): Loperamide Oxide


Related compound F (USP): (1r,4s)-4-(4-Chlorophenyl)-1- O
N
+

MM0025.09 106900-12-3 100mg


[4-(dimethylamino)-4-oxo-3,3-diphenylbutyl]-4- N

hydroxypiperidine 1-oxide hydrate O

Cl
OH

Impurity G (EP): 4-[cis-4-(4-Chlorophenyl)-4-hydroxy-1- N


+

O
MM0025.13 oxidopiperidin-1-yl]-N,N-dimethyl-2,2-diphenylbutanamide 109572-89-6 50mg
(Loperamide cis-N-Oxide) N

Cl

Impurity H (EP): 4-[4-(4-Chlorophenyl)-3,6-


MM0025.11 dihydropyridin-1(2H)-yl]-N,N-dimethyl-2,2- 61299-42-1 100mg N
diphenylbutanamide
N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-353
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cl

MM0025.11- Impurity H (EP): 4-[4-(4-Chlorophenyl)-3,6-


dihydropyridin-1(2H)-yl]-N,N-dimethyl-2,2- 61299-42-1 25mg N
0025 diphenylbutanamide
N

MM0025.07 Ethyl Diphenylacetate 3468-99-3 100mg O

MM0025.07-
Ethyl Diphenylacetate 3468-99-3 25mg O
0025
O

MM0025.08 , -Diphenyl- -butyrolactone 956-89-8 100mg O

O
MM0025.08-
, -Diphenyl- -butyrolactone 956-89-8 25mg O
0025

O
Dimethyl-(tetrahydro-3,3-diphenyl-2- Br
MM0025.10 +
furilidine)ammonium Bromide
37743-18-3 100mg N

O
MM0025.10- Dimethyl-(tetrahydro-3,3-diphenyl-2- Br
+
furilidine)ammonium Bromide
37743-18-3 25mg N
0025

Lopinavir
O
H

MM1151.00 Lopinavir 192725-17-0 250mg N


N

O
O
N

OH
N
H
O

MM1151.22- (2S)-3-Methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanoic OH
192725-50-1 25mg N
0025 Acid O
N O
H

O
MM1151.23- O
2-(2,6-Dimethylphenoxy)acetic Acid 13335-71-2 25mg HO
0025

Loratadine
O
Cl

N O
MM0257.00-
Loratadine 79794-75-5 250mg
0250 N

Impurity A (EP): Ethyl 4-[(11RS)-8-Chloro-11- Cl


O

N O
hydroxy-6,11-dihydro-5H-benzo[5,6]cyclo- OH

MM0257.03 133284-74-9 100mg


hepta[1,2-b]pyridin-11-yl]piperidine-1- N

carboxylate

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-354
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP): Ethyl 4-[(11RS)-8-Chloro-11- Cl


O

N O
MM0257.03- hydroxy-6,11-dihydro-5H-benzo[5,6]cyclo- OH

133284-74-9 25mg
0025 hepta[1,2-b]pyridin-11-yl]piperidine-1- N

carboxylate
Cl

Impurity B (EP): 8-Chloro-5,6-dihydro-11H-


O
benzo[5.6]cyclohepta[1,2-b]pyridin-11-one
MM0257.02
Related compound C (USP): 8-Chloro-5,6-dihydro-11H-
31251-41-9 100mg
N
benzo[5,6]cyclohepta[1,2-b]pyridin-11-one

Cl

Impurity B (EP): 8-Chloro-5,6-dihydro-11H-


O
MM0257.02- benzo[5.6]cyclohepta[1,2-b]pyridin-11-one
Related compound C (USP): 8-Chloro-5,6-dihydro-11H-
31251-41-9 25mg
0025
N
benzo[5,6]cyclohepta[1,2-b]pyridin-11-one

O
Cl

Impurity C (EP): Ethyl 4-(4,8-Dichloro-5,6-dihydro- N O

MM0257.08 11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11- 165739-83-3 100mg N

ylidene)piperidine-1-carboxylate
Cl

O
Cl

MM0257.08- Impurity C (EP): Ethyl 4-(4,8-Dichloro-5,6-dihydro- N O

11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11- 165739-83-3 25mg N


0025 ylidene)piperidine-1-carboxylate
Cl

Cl
Impurity D (EP): 8-Chloro-11-(piperidin-4-ylidene)-
MM0257.01- 6,11-dihydro-5H-benzo[5,6]cyclohepta-[1,2- NH

b]pyridine (Descarboethoxyloratadine; 100643-71-8 250mg


0250 Desloratadine) N

Related compound A (USP): 8-chloro-6,11-dihydro-11(4-


O
Cl

Impurity F (EP): Ethyl 4-[(11RS)-8-Chloro-11-fluoro-6,11- F


N O

MM0257.10 dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11- 125743-80-8 50mg


N
yl]piperidine-1-carboxylate

Impurity G (EP): 8-Chloro-11-(1-methylpiperidin-4- Cl


ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta- N

[1,2-b]pyridine
MM0257.05
Related compound B (USP): 8-Chloro-11-(1-
38092-89-6 100mg
N

methylpiperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]
cyclohepta[1,2-b]pyridine
Impurity G (EP): 8-Chloro-11-(1-methylpiperidin-4- Cl
ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta- N

MM0257.05- [1,2-b]pyridine
Related compound B (USP): 8-Chloro-11-(1-
38092-89-6 25mg
0025 N

methylpiperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]
cyclohepta[1,2-b]pyridine
O

MM0257.07 Impurity H (EP): Ethyl 4-Oxopiperidine-1-carboxylate 29976-53-2 100mg N O

Cl

N
(11RS)-8-Chloro-11-hydroxy-11-(1-methylpiperidin- OH

MM0257.06 4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2- 38089-93-9 100mg


N
b]pyridine

Cl

N
MM0257.06- (11RS)-8-Chloro-11-hydroxy-11-(1-methylpiperidin- OH

4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2- 38089-93-9 25mg


N
0025 b]pyridine

O
Cl
N
MM0257.15-
N-Formyldesloratadine 117810-61-4 25mg
0025 N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-355
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

NH
Deschlorodesloratadine Hydrochloride (6,11-Dihydro-11-
MM0257.19 (piperidin-4-ylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine n/a 100mg N
HCl

Hydrochloride)

NH

MM0257.19- Deschlorodesloratadine Hydrochloride (6,11-Dihydro-11-


(piperidin-4-ylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine n/a 25mg N
HCl

0025 Hydrochloride)
O
Cl

N O
MM0257.20- Ethyl 4-(2,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta
[1,2-b]pyridin-11-ylidene)piperidine-1-carboxylate
165739-64-0 25mg
0025 N

Cl

O
Cl

N O

MM0257.21 Loratadine N-Oxide 165739-62-8 100mg O


+
N

O
Cl

N O
O

MM0257.22 Loratadine Epoxide N-Oxide 1432057-93-6 100mg O


+
N

Cl

MM0257.24-
3-[2-(3-Chlorophenyl)ethyl]-2-pyridinecarboxamide 937642-75-6 25mg N
0025
O N H2

O
Cl

N O
O
MM0257.26-
Loratadine Epoxide 1189694-51-6 25mg
0025 N

Cl
N
N O
MM0257.25- N-Nitrosodesloratadine (8-Chloro-6,11-dihydro-11-(1-nitroso-
1246819-22-6 25mg
0025 4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin) N

Lorazepam
H O
N
OH
MM0071.00- N
Lorazepam 846-49-1 CS 250mg Cl

0250 Cl

N H2
Impurity A (EP): (2-Amino-5-chlorophenyl)(2-
MM0071.01- chlorophenyl)methanone Cl
O

(2-Amino-2',5-dichlorobenzophenone) 2958-36-3 25mg Cl


0025 Related compound B (USP): 2-Amino-2',5-
dichlorobenzophenone
Impurity B (EP): (3RS)-7-Chloro-5-(2-chlorophenyl)- H
N
O

MM0071.07- 2-oxo-2,3-dihydro-1H-1,4-benzodiazepin-3-yl O
N
Acetate (Lorazepam Acetate) 2848-96-6 CS 25mg Cl
O
0025 Related compound A (USP): 7-Chloro-5-(o-chlorophenyl)- Cl

1,3-dihydro-3-acetoxy-2H-1,4-benzodiazepin-2-one
H O
N

Impurity C (EP): 7-Chloro-5-(2-chlorophenyl)- +


Cl N
MM0071.06 1,3-dihydro-2H-1,4-benzodiazepin-2-one 2955-37-5 100mg O
4-Oxide Cl

H O
N

Impurity C (EP): 7-Chloro-5-(2-chlorophenyl)- +


MM0071.06- Cl N
1,3-dihydro-2H-1,4-benzodiazepin-2-one 2955-37-5 25mg O
0025 4-Oxide Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-356
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

H O
N
O
Impurity D (EP): (5RS)-7-Chloro-5-(2-chlorophenyl)- Cl N
MM0071.03 54699-91-1 100mg H
4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione Cl

H O
N
O
MM0071.03- Impurity D (EP): (5RS)-7-Chloro-5-(2-chlorophenyl)- Cl N
54699-91-1 25mg H
0025 4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione Cl

O
N
Impurity E (EP): 6-Chloro-4-(2-chlorophenyl)-
MM0071.02- quinazoline-2-carbaldehyde Cl
N

Related compound C (USP): 6-Chloro-4-(o-chlorophenyl)-2-


93955-15-8 25mg
0025 Cl
quinazolinecarboxaldehyde

6-Chloro-4-(2-chlorophenyl)-2- N
OH
MM0071.04- quinazolinecarboxylic Acid Cl
N

Related compound D (USP): 6-Chloro-4-(o-chlorophenyl)-2-


54643-79-7 25mg
0025 Cl

quinazolinecarboxylic Acid
OH
N
6-Chloro-4-(2-chlorophenyl)-2-quinazoline-
MM0071.08- methanol Cl
N

Related compound E (USP): 6-Chloro-4-(o-chlorophenyl)-2-


773871-49-1 25mg
0025 Cl
quinazoline methanol

H
N O

6-Chloro-4-(2-chlorophenyl)-2(1H)- Cl
N

quinazolinone
MM0071.09 23441-87-4 100mg
Cl

H
N O

MM0071.09- 6-Chloro-4-(2-chlorophenyl)-2(1H)- Cl
N

quinazolinone
23441-87-4 25mg
0025 Cl

Lormetazepam
O
N
OH
MM0072.00-
Lormetazepam 848-75-9 CS 250mg Cl N

0250 Cl

Losartan Potassium
OH
N N
N NH
N
Cl
MM0168.00 Losartan 114798-26-4 100mg N

OH
N N
+
N N K
N

MM0168.03 Losartan Potassium 124750-99-8 250mg


Cl
N

OH

NH
MM0168.13- Impurity A (Pharmeuropa): (2-Butyl-4-chloro-1H- Cl

imidazol-5-yl)methanol
79047-41-9 25mg N
0025

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-357
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N N
HN N
MM0168.14- Impurity B (EP): [2'-(1H-Tetrazol-5-yl)biphenyl- HO
160514-13-6 25mg
0025 4-yl]methanol

N N
Cl
Impurity C (EP): [2-Butyl-5-chloro-1-[[2'-(1H- N
HN N

MM0168.04 tetrazol-5-yl)biphenyl-4-yl]methyl]-1H- 114799-13-2 50mg HO N

imidazol-4-yl]methanol
O

Impurity D (EP) : 2-Butyl-4-chloro-1H-imidazole- NH


5-carbaldehyde Cl
MM0168.08
Related compound A (USP): 2-Butyl-4-chloro-1H-imidazole-
83857-96-9 100mg N

5-carbaldehyde

Impurity D (EP) : 2-Butyl-4-chloro-1H-imidazole- NH


MM0168.08- 5-carbaldehyde Cl

Related compound A (USP): 2-Butyl-4-chloro-1H-imidazole-


83857-96-9 25mg N
0025
5-carbaldehyde

N N
HN N
Impurity E (EP): 5-(4'-Methylbiphenyl-2-yl)-1H-
MM0168.05 120568-11-8 50mg
tetrazole

N N
HN N
MM0168.05- Impurity E (EP): 5-(4'-Methylbiphenyl-2-yl)-1H-
120568-11-8 25mg
0025 tetrazole

Impurity F (EP) : 5-[4'[[2-Butyl-4-chloro-5-[[(1- O


N N
HN N
methylethyl)oxy]methyl]-1H-imidazol-1-yl]- Cl
N

MM0168.15 n/a 100mg N


methyl]biphenyl-2-yl]-1H-tetrazole (Losartan
Isopropyl Ether)
Impurity F (EP) : 5-[4'[[2-Butyl-4-chloro-5-[[(1- O
N N
HN N
MM0168.15- methylethyl)oxy]methyl]-1H-imidazol-1-yl]- Cl
N

n/a 25mg N
0025 methyl]biphenyl-2-yl]-1H-tetrazole (Losartan
Isopropyl Ether)

MM0173.04 Impurity G (EP) : Triphenylmethanol 76-84-6 100mg OH

MM0173.04-
Impurity G (EP) : Triphenylmethanol 76-84-6 25mg OH
0025

Impurity H (EP) : [2-Butyl-4-chloro-1-[[2'-[2- OH


N N

MM0168.16 (triphenylmethyl)-2H-tetrazol-5-yl]biphenyl- 133909-99-6 100mg Cl


N
N N

N
4-yl]methyl]-1H-imidazol-5-yl]methanol

MM0168.16- Impurity H (EP) : [2-Butyl-4-chloro-1-[[2'-[2- OH


N N

(triphenylmethyl)-2H-tetrazol-5-yl]biphenyl- 133909-99-6 25mg Cl


N
N N

N
0025 4-yl]methyl]-1H-imidazol-5-yl]methanol

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-358
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0168.17- Impurity I (EP): 5-[4'-[[2-Butyl-4-chloro-5- O


N N

[[(triphenylmethyl]oxy]methyl]-1H-imidazol- 1006062-28-7 25mg Cl


N
HN N

0025 1-yl]methyl]biphenyl-2-yl]-1H-tetrazole N

Impurity J (EP) : [2-Butyl-4-chloro-1-[[2'-(1H- O

O
tetrazol-5-yl)biphenyl-4-yl]methyl]-1H- HN
N N
N

MM0168.18 imidazol-5-yl]methyl Acetate 1006062-27-6 100mg Cl


N
N

Related compound B (USP): 2-Butyl-4-chloro-(1-[2'-(1H-


tetrazol-5-yl)biphenyl-4-yl]methyl-1H-imidazol-5-yl)methyl

Impurity J (EP) : [2-Butyl-4-chloro-1-[[2'-(1H- O

MM0168.18- tetrazol-5-yl)biphenyl-4-yl]methyl]-1H- HN
N N
N

imidazol-5-yl]methyl Acetate 1006062-27-6 25mg Cl


N
N

0025 Related compound B (USP): 2-Butyl-4-chloro-(1-[2'-(1H-


tetrazol-5-yl)biphenyl-4-yl]methyl-1H-imidazol-5-yl)methyl

Impurity K (EP) : 2-Butyl-4-chloro-1-[[2'-(1H- O


N N

tetrazol-5-yl)biphenyl-4-yl]methyl]-1H- N
HN N
Cl
MM0168.10 imidazol-5-carbaldehyde 114798-36-6 100mg N

Related compound C (USP): 2-Butyl-4-chloro-1-[[2'-(1H-


tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-imidazol-5-

Impurity K (EP) : 2-Butyl-4-chloro-1-[[2'-(1H- O


N N

tetrazol-5-yl)biphenyl-4-yl]methyl]-1H- N
HN N
MM0168.10- Cl
imidazol-5-carbaldehyde 114798-36-6 25mg N

0025 Related compound C (USP): 2-Butyl-4-chloro-1-[[2'-(1H-


tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-imidazol-5-

Impurity L (EP): [2-Butyl-1-[[2'-[1-[[2-butyl-4-


chloro-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-
yl]methyl]-1H-imidazol-5-yl]methyl]-1H- N
N

N NH

MM0168.06- tetrazol-5-yl]biphenyl-4-yl]methyl-4-chloro-
1H-imidazol-5-yl]methanol 230971-71-8 25mg OH

N
N N
N
N N

0025 Related compound D (USP): 5-[4'-(2-Butyl-5-[(5-4'-[(2-butyl- Cl


N
N Cl

4-chloro-5-hydroxymethyl-1H-imidazol-1-yl)methyl]biphenyl-2-
yl-1H-tetrazol-1-yl)methyl]-4-chloro-1H-imidazol-1-ylmethyl)
biphenyl-2-yl]tetrazol, potassium salt
Impurity L (EP) as Potassium Salt: Potassium 5-[4'-[[2-Butyl-
4-chloro-5-[5-[4'-[[2-Butyl-4-chloro-5-(hydroxymethyl)-1H- +
N

imidazol-1-yl]methyl]biphenyl-2-yl]tetrazol-1-yl]methyl-1H- K N
N N

MM0168.32- imidazol-1-yl]methyl]biphenyl-2-yl]tetrazolide OH N N
N N

Related compound D (USP): 5-[4'-(2-Butyl-5-[(5-4'-[(2-butyl-


212316-86-4 25mg N N
0025 Cl
N Cl

4-chloro-5-hydroxymethyl-1H-imidazol-1-yl)methyl]biphenyl-2- N

yl-1H-tetrazol-1-yl)methyl]-4-chloro-1H-imidazol-1-ylmethyl)
biphenyl-2-yl]tetrazol, potassium salt
Impurity M (EP): [2-Butyl-1-[[2'-[2-[[2-butyl-4-
chloro-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-
yl]methyl]-1H-imidazol-5-yl]methyl]-2H-
N N
N
N
H

MM0168.07- tetrazol-5-yl]biphenyl-4-yl]methyl]-4-chloro-
1H-imidazol-5-yl]methanol
N
OH
230971-72-9 25mg N
N
N
N Cl
N

Related compound E (USP): 5-[4'-(2-Butyl-5-[(5-4'-[(2-butyl-


0025 N
Cl
N

4-chloro-5-hydroxymethyl-1H-imidazol-1-yl)methyl]biphenyl-2-
yl-2H-tetrazol-2-yl)methyl]-4-chloro-1H-imidazol-1-ylmethyl)
biphenyl-2-yl]tetrazol, potassium salt
Impurity M (EP) as Potassium Salt: Potassium 5-[4'-[[2-Butyl-
4-chloro-5-[5-[4'-[[2-butyl-4-chloro-5-(hydroxymethyl)-1H-
N N
+
K N
N
imidazol-1-yl]methyl]biphenyl-2-yl]tetrazol-2-yl]methyl-1H-
MM0168.33- imidazol-1-yl]methyl]biphenyl-2-yl]tetrazolide N
OH
212316-88-6 25mg N
N
N
N Cl
N

0025 Related compound E (USP): 5-[4'-(2-Butyl-5-[(5-4'-[(2-butyl- N


Cl
N

4-chloro-5-hydroxymethyl-1H-imidazol-1-yl)methyl]biphenyl-
2-yl-2H-tetrazol-2-yl)methyl]-4-chloro-1H-imidazol-1-ylmethyl)
biphenyl-2-yl]tetrazol, potassium salt

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-359
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
O N N
2-Butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl] N
N NH
MM0168.01- Cl
methyl]-1H-imidazole-5-carboxylic Acid (Losartan Carboxylic 124750-92-1 25mg N

0025
Acid)

O
N N
HN N
MM0168.11- N
Losartan Butyl Ether n/a 25mg Cl
N
0025

O
N N
HN N
N
Cl
MM0168.12 Losartan Methyl Ether 114798-94-6 100mg N

O
N N
HN N
N
MM0168.12- Cl
Losartan Methyl Ether 114798-94-6 25mg N
0025

N N
HN N

MM0168.21 5-Phenyl-1H-tetrazole 18039-42-4 100mg

N N
HN N
MM0168.21-
5-Phenyl-1H-tetrazole 18039-42-4 25mg
0025

OH
N
N
2-[4-[[2-Butyl-4-chloro-5-(hydroxymethyl)imidazol-1-yl]methyl] Cl
MM0168.22 114772-55-3 100mg N
phenyl]benzonitrile

OH
N
N
MM0168.22- 2-[4-[[2-Butyl-4-chloro-5-(hydroxymethyl)imidazol-1-yl]methyl] Cl
114772-55-3 25mg N
0025 phenyl]benzonitrile

N
Br

MM0168.23 2-(4-Bromomethylphenyl)benzonitrile 114772-54-2 100mg

N
Br
MM0168.23-
2-(4-Bromomethylphenyl)benzonitrile 114772-54-2 25mg
0025

Cl N
MM0168.24- 3-[(4-Bromophenyl)methyl]-2-butyl-5-chloroimidazole-4- N
143722-29-6 25mg Br
0025 carbaldehyde

O
N N
HN N
MM0168.26- N
Cl
Losartan Ethyl Ether n/a 25mg N
0025

O N N
O N NH
MM0168.27- 2-Oxo-2-[[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl] O
N
H
914465-61-5 25mg
0025 amino]ethyl Pentanoate
O N N
HO N NH
MM0168.28- 2-Hydroxy-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl] N
H
914465-63-7 25mg
0025 acetamide

O
N N
MM0168.31- 2-Butyl-4-chloro-1-[[2'-[2-(triphenylmethyl)-2H-tetrazol-5-yl] N N
Cl N
133910-00-6 25mg N
0025 [1,1'-biphenyl]-4-yl]methyl]-1H-Imidazole-5-carboxaldehyde

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-360
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
N
N
MM0168.38- 2-[4-[(2-Butyl-4-chloro-5-formylimidazol-1-yl)methyl]phenyl] Cl
124750-67-0 25mg N
0025 benzonitrile

5-[4'-[[2-Butyl-4-chloro-5-[[(triphenylmethyl)oxy]methyl]-1H-
O
MM0168.39- N N
N N
imidazol-1-yl]methyl]biphenyl-2-yl]-2-(triphenylmethyl) 1796930-34-1 25mg Cl
N

0025 N

tetrazole

N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20

N
MM0487.10A N O
N-Nitrosodiethylamine (NDEA) 0.1 mg/ml in Methanol 55-18-5 1ml
ME-00.10

Loteprednol Etabonate
Cl
O
O
HO O
MM3645.00 Loteprednol Etabonate 82034-46-6 250mg H
O
O

H H
O

Lovastatin
O

OH
MM0050.00 Lovastatin 75330-75-5 100mg H
O O

Impurity A (EP): (1S,7S,8S,8aR)-8-[2-[(2R,4R)-4- O

Hydroxy-6-oxotetrahydro-2H-pyran-2-yl]- O

MM0377.00 ethyl]-7-methyl-1,2,3,7,8,8a-hexahydro- 73573-88-3 100mg H


OH
O O
naphthalen-1-yl (2S)-2-Methylbutanoate
(Mevastatin)
Impurity B (EP) as Sodium Salt: O

(3R,5R)-7-[(1S,2S,6R,8S,8aR)-2,6- OH O
Na
+

Dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]- H
OH
MM0050.01 75225-50-2 100mg O O
1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-
3,5-dihydroxyheptanoic Acid Sodium Salt
(Lovastatin Hydroxy Acid Sodium Salt)
Impurity B (EP) as Sodium Salt: O

(3R,5R)-7-[(1S,2S,6R,8S,8aR)-2,6- OH O
Na
+

MM0050.01- Dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]- H
OH
75225-50-2 25mg O O
0025 1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-
3,5-dihydroxyheptanoic Acid Sodium Salt
(Lovastatin Hydroxy Acid Sodium Salt)
O

Impurity C (EP): (1S,3R,7S,8S,8aR)-3,7- O


Dimethyl-8-[2-[(2R)-6-oxo-3,6-dihydro-2H-
MM0050.03 pyran-2-yl]ethyl]-1,2,3,7,8,8a-hexahydro- 109273-98-5 100mg H
O O
naphthalen-1-yl (2S)-2-Methylbutanoate
(Dehydrolovastatin)

Impurity C (EP): (1S,3R,7S,8S,8aR)-3,7- O

MM0050.03- Dimethyl-8-[2-[(2R)-6-oxo-3,6-dihydro-2H-
pyran-2-yl]ethyl]-1,2,3,7,8,8a-hexahydro- 109273-98-5 25mg H
O O
0025 naphthalen-1-yl (2S)-2-Methylbutanoate
(Dehydrolovastatin)
O
Lovastatin Diol Lactone ((4R,6R)-6-[2-[(1S,2S,6R,8S,8aR)- O

MM0158.14- 1,2,6,7,8,8a-Hexahydro-8-hydroxy-2,6-dimethyl-1- OH
H
79952-42-4 25mg OH
0025 naphthalenyl]ethyl]tetrahydro-4-hydroxy-2H-pyran-2-one)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-361
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Loxapine Succinate
N O

OH
MM1530.00 Loxapine Succinate 27833-64-3 250mg N
N
OH
Cl
O
O

N
3-Chloro-11-(4-methylpiperazin-1-yl)dibenzo[b,f][1,4]
oxazepine N
MM1530.01 3454-96-4 100mg N
Related compound A (USP): 3-Chloro-11-(4-
methylpiperazin-1-yl)dibenzo[b,f][1,4]oxazepine O
Cl

N
3-Chloro-11-(4-methylpiperazin-1-yl)dibenzo[b,f][1,4]
MM1530.01- oxazepine N
3454-96-4 25mg N
0025 Related compound A (USP): 3-Chloro-11-(4-
methylpiperazin-1-yl)dibenzo[b,f][1,4]oxazepine O
Cl

+O
N

N
MM1530.04 Loxapine N-Oxide 25967-34-4 100mg N
Cl

Loxoprofen Sodium
O

MM3940.00- O
Loxoprofen Sodium 80382-23-6 250mg O Na
+
0250

Lucanthone Hydrochloride
HCl
O

MM1641.00 Lucanthone Hydrochloride 548-57-2 50mg S


H
N
N

Lufenuron
F Cl
F O
MM3415.00- O O F
F F F F
Lufenuron 103055-07-8 250mg N
H
N
H
0250 Cl
F

Lurasidone Hydrochloride
H
H O

MM3647.00 Lurasidone Hydrochloride 367514-88-3 250mg


H H
O
N
HCl

N S

Lynestrenol
OH

H H
MM1787.00 Lynestrenol 52-76-6 250mg
H H

Lysergide
O

N N
H

MM1346.00 Lysergide 50-37-3 CS 100mg


N
H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-362
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HO N
H

MM1346.03 Lysergic Acid 82-58-6 100mg

N
H

HO N
H
MM1346.03-
Lysergic Acid 82-58-6 25mg
0025
N
H

Lysine Clonixinate
O

OH O
H2 N

MM3687.00 Lysine Clonixinate 55837-30-4 250mg N NH


NH2
OH

Cl

Lysine Hydrochloride
N H2
MM1521.00-
Lysine Hydrochloride (L-Lysine Hydrochloride) 657-27-2 250mg H2 N
O H HCl

0250 O

Macitentan
O O
S Br
N NH
H
MM3908.00-
Macitentan 441798-33-0 250mg N

N O
O N
0250 N
Br

Mafenide Acetate
O O
S O

MM1059.00 Mafenide Acetate 13009-99-9 250mg H 2N


N H2
OH

Mafenide Hydrochloride
O O
S
MM3127.00 Mafenide Hydrochloride 138-37-4 100mg H 2N
N H2 HCl

Magnesium Aspartate Dihydrate


O
MM0460.10- HO
Impurity C (EP): (2E)-But-2-enedioic Acid (Fumaric Acid) 110-17-8 250mg OH
0250 O

NH2
Impurity D (EP): (2S)-2-Aminopentanedioic Acid (Glutamic HO OH
MM1333.00 56-86-0 250mg
Acid) O O

O
MM0567.05- HO
Impurity F (EP): Butanedioic Acid (Succinic Acid) 110-15-6 100mg OH
0100 O

NH2
MM0169.00- Impurity G (EP): (2S)-2,5-Diamino-5-oxopentanoic Acid (L- H 2N OH
56-85-9 250mg
0250 Glutamine) O O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-363
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Magnesium Orotate Dihydrate


H
O N O

MM0881.00-
Orotic Acid 65-86-1 250mg NH
0250
O OH

Magnesium Pidolate
NH2
Impurity A (EP): (2S)-2-Aminopentanedioic Acid (Glutamic HO OH
MM1333.00 56-86-0 250mg
Acid) O O

Maleic Acid
O

MM1439.00- OH
Maleic Acid 110-16-7 250mg
0250 OH

Malic Acid
O
HO
MM1332.00 Malic Acid 6915-15-7 250mg OH
O OH

O
MM0460.10- HO
Impurity A (EP): (E)-Butenedioic Acid (Fumaric Acid) 110-17-8 250mg OH
0250 O

MM1439.00- OH
Impurity B (EP): (Z)-Butenedioic Acid (Maleic Acid) 110-16-7 250mg
0250 OH

Maltitol
OH
HO OH
O

MM3570.00 Maltitol (D-Maltitol) 585-88-6 250mg HO O


OH

HO OH
HO
OH

Maltol
O

MM0975.01 Maltol (3-Hydroxy-2-methyl-4-pyrone) 118-71-8 250mg


OH
O

Maltose Monohydrate
OH
HO OH
H
O
O

MM1546.00 Maltose Monohydrate 6363-53-7 250mg HO


O
OH
H2O
OH
HO
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-364
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Mandelic Acid
O

MM0792.06 Methyl Mandelate 4358-87-6 100mg O


OH

O
MM0792.06-
Methyl Mandelate 4358-87-6 25mg O
0025
OH

MM3498.01 Ethyl Mandelate 774-40-3 100mg O


OH

MM1376.05 Isopropyl Mandelate 4118-51-8 100mg O


OH

O
MM1376.05-
Isopropyl Mandelate 4118-51-8 25mg O
0025 OH

Mannitol
OH
OH
HO
MM0654.00 Mannitol 69-65-8 250mg OH
OH
HO

OH
OH
HO
MM1492.00 Impurity A (EP): D-Glucitol (D-Sorbitol) 50-70-4 250mg OH
OH
HO

Maprotiline Hydrochloride

N
MM0820.00 Maprotiline Hydrochloride 10347-81-6 250mg H HCl

Impurity A (EP): 3-(9,10-Ethanoanthracen- O


MM0820.01 38849-09-1 50mg
9(10H)-yl)prop-2-enal

Impurity B (EP) as Hydrochloride: 3-(9,10- HCl

Ethanoanthracen-9(10H)-yl)-N-[3-(9,10- N
MM0820.02 n/a 10mg
ethanoanthracen-9(10H)-yl)propyl]-N-
methylpropan-1-amine Hydrochloride
Impurity B (EP) as Hydrochloride: 3-(9,10- HCl

MM0820.02- Ethanoanthracen-9(10H)-yl)-N-[3-(9,10- N
n/a 25mg
0025 ethanoanthracen-9(10H)-yl)propyl]-N-
methylpropan-1-amine Hydrochloride

MM0820.03- Impurity C (EP) as Hydrochloride: 3-(9,10-


NH2
Ethanoanthracen-9(10H)-yl)propan-1- 92202-51-2 25mg HCl

0025 amine Hydrochloride


Impurity D (EP) as Hydrochloride: 3-(9,10-
Ethanoanthracen-9(10H)-yl)-N-methylprop-
2-en-1-amine Hydrochloride N
H HCl

(Dehydromaprotiline Hydrochloride)
MM0820.04 38849-14-8 50mg
Related compound D (USP): 3-(9,10-dihydro-9,10-
ethanoanthracen-9-yl)-N-methylprop-2-en-1-amine
Impurity E (EP) as Hydrochloride: 3-(9,10-
N
MM0820.05 Ethanoanthracen-9(10H)-yl)-N,N- 23941-45-9 100mg HCl

dimethylpropan-1-amine Hydrochloride

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-365
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0820.05- Impurity E (EP) as Hydrochloride: 3-(9,10-


N
Ethanoanthracen-9(10H)-yl)-N,N- 23941-45-9 25mg HCl

0025 dimethylpropan-1-amine Hydrochloride

Maraviroc
H H
F N
N
MM3904.00- F N
Maraviroc
H
N N
376348-65-1 250mg O
H
0250

Marbofloxacin
N O N
N N

MM3384.00 Marbofloxacin 115550-35-1 250mg OH


F
O O

Mebendazole
O
H
N O

MM0882.00 Mebendazole 31431-39-7 250mg N


N
H

Impurity A (EP): (2-Amino-1H-benzimidazol-5- H


N
yl)phenylmethanone N H2
MM0882.01 N
Related compound A (USP): 2-amino-5-
52329-60-9 50mg
O

benzoylbenzimidazole
Impurity B (EP): (2-Hydroxy-1H-benzimidazol-5- H
N
yl)phenylmethanone OH
N
Related compound B (USP): 5-benzoyl-1H-benzo[d]
MM0882.02 21472-33-3 50mg
O

imidazole-2(3H)-one
Impurity C (EP): (2-Amino-1-methyl-1H-benzimidazol-5-yl)
MM0882.03- phenylmethanone 66066-76-0 25mg
N
N H2
N
0025 Related compound C (USP): 2-Amino-5-benzoyl-1- O
methylbenzimidazole
Impurity D (EP): Methyl (5-Benzoyl-1-methyl-1H- O

benzimidazol-2-yl)carbamate N
N
H
O

Related compound D (USP): Methyl 5-benzoyl-1-


MM0882.04 132119-11-0 50mg N

methylbenzimidazol-2-ylcarbamate
Impurity E (EP): Ethyl (5-Benzoyl-1H-benzimidazol- O
H
MM0882.05- 2-yl)carbamate N
N
H
O

Related compound E (USP): Ethyl(5-benzoyl-1H-


31430-19-0 25mg N
0025 O

benzimidazol-2-yl)carbamate
Impurity F (EP): Methyl [5-(4-Methylbenzoyl)-1H- O
H
MM0882.06- benzimidazol-2-yl]carbamate N
N
H
O

Related compound F (USP): Methyl 5-(4-toluoyl)-1H-


31545-31-0 25mg N
0025 O

benzimidazol-2-ylcarbamate

Mebeverine Hydrochloride
O
N

MM0319.00 Mebeverine Hydrochloride 2753-45-9 100mg O


O
O

HCl
O

MM0938.14 Impurity A (EP): 1-(4-Methoxyphenyl)propan-2-one 122-84-9 100mg O


O

Impurity B (EP) as Hydrochloride: (2RS)-N-Ethyl-1-(4-


HN HCl
MM0319.03 methoxyphenyl)propan-2-amine Hydrochloride (N-[(1RS)-1- 93963-24-7 CS 100mg
O
[(4-Methoxyphenyl)methyl]ethyl]ethanamine Hydrochloride)
Impurity B (EP) as Hydrochloride: (2RS)-N-Ethyl-1-(4-
MM0319.03- HN HCl
methoxyphenyl)propan-2-amine Hydrochloride (N-[(1RS)-1- 93963-24-7 CS 25mg
0025 O
[(4-Methoxyphenyl)methyl]ethyl]ethanamine Hydrochloride)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-366
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
MM0319.01 Impurity D (EP): 3,4-Dimethoxybenzoic Acid (Veratric Acid) 93-07-2 100mg
O
O

MM0319.01- OH
Impurity D (EP): 3,4-Dimethoxybenzoic Acid (Veratric Acid) 93-07-2 25mg
0025 O
O

MM0319.02 4-Methoxyphenylacetone 100-06-1 100mg


O

O
MM0319.02-
4-Methoxyphenylacetone 100-06-1 25mg
0025
O

O
MM0487.18- N O
N-Nitroso-N-ethyl-4-aminobutyric Acid 54897-63-1 100mg N
0100 OH

Mebhydrolin Napadisilate
O
HO
N S O

MM1891.00 Mebhydrolin Napadisilate 6153-33-9 100mg N

O S
OH
O
2

O
+
N

MM1891.01-
Mebhydrolin N-Oxide 210408-26-7 25mg N
0025

Mebrofenin
O OH
H
N

MM3594.00 Mebrofenin 78266-06-5 100mg O


N
OH

Br O

O OH
H O
MM3594.01- N +
N
Mebrofenin N-Oxide n/a 25mg O OH
0025
Br O

Mechlorethamine Hydrochloride

MM0823.00 Mechlorethamine Hydrochloride 55-86-7 500mg Cl


N
Cl
HCl

Meclizine Hydrochloride, see Meclozine Hydrochloride

Meclofenamate Sodium
O
+
O Na H 2O
MM3888.00- NH
Meclofenamate Sodium Monohydrate 67254-91-5 250mg Cl Cl
0250

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-367
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Meclofenamic Acid
O

OH

MM3124.00 Meclofenamic Acid 644-62-2 50mg NH


Cl Cl

Meclofenoxate Hydrochloride
O
O N
MM0044.00 Meclofenoxate Hydrochloride 3685-84-5 500mg O

HCl
Cl

O
O
MM0044.02 (4-Chlorophenoxy)acetic Acid 122-88-3 100mg OH

Cl

O
MM0044.02- O
(4-Chlorophenoxy)acetic Acid 122-88-3 25mg OH

0025 Cl

O
MM0044.05- O
O
(4-Chlorophenoxy)acetic Acid Ethyl Ester 14426-42-7 25mg
0025 Cl

O
MM0044.06- O
O
(4-Chlorophenoxy)acetic Acid Isopropyl Ester 41944-93-8 25mg
0025 Cl

Meclozine Dihydrochloride (Meclizine Hydrochloride)


MM0586.00-
Meclozine Dihydrochloride 1104-22-9 250mg N
HCl
2

0250 N
Cl

MM0586.06 3-Methylbenzaldehyde 620-23-5 100mg


O

Impurity B (EP): (RS)-(4-Chlorophenyl)phenyl-


MM0380.09 methanol (4-Chlorobenzhydrol) 119-56-2 100mg
OH
Related compound A (USP): 4-chlorobenzhydrol
Cl

Impurity B (EP): (RS)-(4-Chlorophenyl)phenyl-


MM0380.09-
methanol (4-Chlorobenzhydrol) 119-56-2 25mg
OH
0025 Related compound A (USP): 4-chlorobenzhydrol
Cl

Impurity C (EP): (4-Chlorophenyl)phenyl-


MM0380.10 134-85-0 100mg
methanone (4-Chlorobenzophenone) O

Cl

MM0380.10- Impurity C (EP): (4-Chlorophenyl)phenyl-


134-85-0 25mg
0025 methanone (4-Chlorobenzophenone) O

Cl

Impurity D (EP): 1,1'-(1,3-Phenylenebismethylene)- N


N

MM0586.08 1207847-84-4 50mg Cl

bis[4-[(4-chlorophenyl)phenylmethyl]piperazine] N
N
Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-368
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity E (EP): 1-(Diphenylmethyl)-4-[(3-methyl-


MM0586.09 16896-82-5 50mg
phenyl)methyl]piperazine N
N

Impurity F (EP): 1,4-Bis[(4-chlorophenyl)phenyl- N


Cl

MM0380.04 346451-15-8 100mg N

methyl]-piperazine Cl

MM0380.04- Impurity F (EP): 1,4-Bis[(4-chlorophenyl)phenyl- N


Cl

346451-15-8 25mg N

0025 methyl]-piperazine Cl

Cl
NH
Impurity H (EP): 1-[(RS)-(4-Chlorophenyl)phenyl- N

MM0380.01 methyl]piperazine ((RS)-1-[(4-Chlorophenyl)- 303-26-4 100mg


phenylmethyl]piperazine)
Cl
NH

MM0380.01- Impurity H (EP): 1-[(RS)-(4-Chlorophenyl)phenyl- N

methyl]piperazine ((RS)-1-[(4-Chlorophenyl)- 303-26-4 25mg


phenylmethyl]piperazine)
0025

MM0586.05 Meclozine N-Oxide 114624-69-0 10mg N


+
N
Cl
O

MM0586.07- HN
N-(3-Methylbenzyl)piperazine Dihydrochloride 5321-61-9 25mg N
HCl
2
0025

Medazepam

MM0934.00 Medazepam 2898-12-6 CS 250mg Cl N

Medrogestone
O

H
MM0869.00 Medrogestone 977-79-7 100mg
H H
O

Medronic Acid

O
MM3503.01 Impurity A (EP): Tris(1-methylethoxy)phosphane 116-17-6 100mg P
O O

O O O O
Impurity B (EP): Tetrakis(1-methylethyl) P P
MM3503.02 1660-95-3 100mg O O
Methylenediphosphonate

Medroxyprogesterone
O
OH

H
MM0635.00 Medroxyprogesterone 520-85-4 100mg H H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-369
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Medroxyprogesterone Acetate
O
O

MM0532.00- H O
Medroxyprogesterone Acetate 71-58-9 250mg H H
0250 O

Impurity A (EP): 6 -Hydroxy-6-methyl-3,20- O

H O
MM0532.01 dioxopregn-4-en-17-yl Acetate 984-47-4 100mg H H

(6 -Hydroxymedroxyprogesterone Acetate) O
OH

Impurity A (EP): 6 -Hydroxy-6-methyl-3,20- O

MM0532.01- H O
dioxopregn-4-en-17-yl Acetate 984-47-4 25mg H H
0025
(6 -Hydroxymedroxyprogesterone Acetate) O
OH

O
Impurity B (EP): 17-Hydroxy-6 -methylpregn-4- OH

ene-3,20-dione (Medroxyprogesterone) H
MM0635.00 520-85-4 100mg
Related compound B (USP): 17-Hydroxy-6alpha- H H
O
methylpregn-4-ene-3,20-dione
O

Impurity E (EP): 6-Methylidene-3,20-dioxopregn-4- O


H
MM0532.05 en-17-yl Acetate (6-Methylenehydroxyprogesterone 32634-95-0 100mg H H
O

Acetate) O

Impurity E (EP): 6-Methylidene-3,20-dioxopregn-4- O


MM0532.05- H
en-17-yl Acetate (6-Methylenehydroxyprogesterone 32634-95-0 25mg H H
O

0025 Acetate) O

Impurity F (EP): 6 -Methyl-3,20-dioxo-5 -pregnan- O

17-yl Acetate (4,5 -Dihydromedroxyprogesterone H


O

MM0532.06 Acetate) 69688-15-9 50mg H H


O

Related compound A (USP): 6alpha-Methyl-3,20- O


H

dioxopregnan-17-yl acetate
O

O
Impurity G (EP): 6-Methyl-3,20-dioxopregna- H
O
MM0532.07 595-33-5 250mg
4,6-dien-17-yl Acetate (Megestrol Acetate) O
H H

Impurity H (EP): 3,20-Dioxopregn-4-en-17-yl Acetate H


O

MM0532.09 302-23-8 100mg


(Hydroxyprogesterone Acetate) H H
O

MM0532.09- Impurity H (EP): 3,20-Dioxopregn-4-en-17-yl Acetate H


O

302-23-8 25mg
0025 (Hydroxyprogesterone Acetate) H H
O

Medrylamine Maleate
O
O
O

Medrylamine Maleate
N OH
MM3123.00 60407-52-5 50mg OH

Mefenamic Acid
O

OH
MM0327.00-
Mefenamic Acid 61-68-7 250mg NH
0250

NH2

MM0327.01 Impurity A (EP): 2,3-Dimethylaniline 87-59-2 100mg

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-370
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity B (EP): N-(2,3-Dimethylphenyl)-2- N


H
MM0327.02 21122-68-9 100mg
[(2,3-dimethylphenyl)amino]benzamide NH

MM0327.02- Impurity B (EP): N-(2,3-Dimethylphenyl)-2- N


H
21122-68-9 25mg
0025 [(2,3-dimethylphenyl)amino]benzamide NH

MM0217.14 Impurity C (EP): 2-Chlorobenzoic Acid 118-91-2 100mg OH

Cl

O
MM0217.14-
Impurity C (EP): 2-Chlorobenzoic Acid 118-91-2 25mg OH
0025
Cl

O
MM0278.01-
Impurity D (EP): Benzoic Acid 65-85-0 250mg OH
0250

MM0327.07 Mefenamic Acid Methyl Ester 1222-42-0 100mg NH

O
MM0327.07-
Mefenamic Acid Methyl Ester 1222-42-0 25mg NH
0025

O
MM0327.08-
Mefenamic Acid Ethyl Ester 1226-33-1 25mg NH
0025

O
MM0327.09-
Mefenamic Acid Isopropyl Ester n/a 25mg NH
0025

O OH O

O O OH
Mefenamic Acid 1,3-Butylene Glycol Esters (Mixture of NH NH
MM0327.10 n/a 100mg
Isomers)
O

O
OH
MM0327.11 Mefenamic Acid 2,3-Butylene Glycol Ester 95093-55-3 100mg NH

O O
OH
O O
MM0327.12- Mefenamic Acid 1,2-Propylene Glycol Esters (Mixture of NH
OH
NH
n/a 25mg
0025 Isomers)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-371
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
O O
OH
O OH O
MM0327.13- Mefenamic Acid 1,2,3-Propanetriol Esters (Mixture of NH
OH
NH
n/a 25mg
0025 Isomers)

Mefloquine Hydrochloride
AND Enantiomer
F
F
F F F
N
F
MM1198.00 Mefloquine Hydrochloride 51773-92-3 250mg HCl
H
HO
H N

AND Enantiomer
Impurity C (EP) as Hydrochloride: (RS)-[2,8-Bis F
F
F F F
N
(trifluoromethyl)quinolin-4-yl][(2RS)-piperidin-2-yl]methanol F
MM1198.03 58560-52-4 100mg HCl
Hydrochloride (threo-Mefloquine Hydrochloride) H
HO

Related compound A (USP): threo-mefloquine H N

AND Enantiomer
Impurity C (EP) as Hydrochloride: (RS)-[2,8-Bis F
F
F F F
N
MM1198.03- (trifluoromethyl)quinolin-4-yl][(2RS)-piperidin-2-yl]methanol F
58560-52-4 25mg HCl
0025 Hydrochloride (threo-Mefloquine Hydrochloride) H
HO

Related compound A (USP): threo-mefloquine H N

F
F
F F F
N
MM1198.01 35853-41-9 100mg F
2,8-Bis(trifluoromethyl)-4-quinolinol

OH

F
F
F F F
MM1198.01- N
35853-41-9 25mg F
2,8-Bis(trifluoromethyl)-4-quinolinol
0025
OH

F
F
F F F
N
F
MM1198.02 2,8-Bis-(trifluoromethyl)-4-quinolinecarboxylic Acid 35853-50-0 100mg

O OH

F
F
F F F
N
MM1198.02- F
2,8-Bis-(trifluoromethyl)-4-quinolinecarboxylic Acid 35853-50-0 25mg
0025
O OH

AND Enantiomer
F F

N
F
MM1198.06- (1RS,3SR,8aSR)-1,3-Bis[2,8-bis(trifluoromethyl)-4-quinolyl]- H
F
H
O
n/a 25mg F
H
N
0025 3,5,6,7,8,8a-hexahydro-1H-oxazolo[3,4-a]pyridine
F
N
F F
F F F

Megestrol Acetate
O

O
H
MM0532.07 Megestrol Acetate 595-33-5 250mg H H
O

MM0532.00- Impurity A (EP): 6 -Methyl-3,20-dioxopregn-4- H


O

O
en-17-yl Acetate (Medroxyprogesterone 71-58-9 250mg H H

Acetate)
0250 O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-372
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
Impurity D (EP): 6-Methylidene-3,20-dioxopregn-4-en-17-yl O
H
MM0532.05 Acetate (6-Methylene Hydroxyprogesterone Acetate) 32634-95-0 100mg O
H H
O
Related compound D (USP): 6-Methylene-3,20-dioxopregn-

O
Impurity D (EP): 6-Methylidene-3,20-dioxopregn-4-en-17-yl O
MM0532.05- H
Acetate (6-Methylene Hydroxyprogesterone Acetate) 32634-95-0 25mg O
H H
0025 O
Related compound D (USP): 6-Methylene-3,20-dioxopregn-

MM0532.09 Impurity K (EP): 3,20-Dioxopregn-4-en-17-yl Acetate 302-23-8 100mg H


O
H H
O

MM0532.09- O

Impurity K (EP): 3,20-Dioxopregn-4-en-17-yl Acetate 302-23-8 25mg H


O
0025 H H
O

Meglumine
H
N
OH

MM3394.00 Meglumine 6284-40-8 250mg HO


OH
OH
HO

Melatonin
O
H
N
MM1373.00-
Melatonin 73-31-4 250mg O
0250
N
H

2-(5-Methoxy-1H-indol-3-yl)ethanamine (5- NH2

Methoxytryptamine) O
MM1373.01 608-07-1 100mg
Related compound A (USP): 2-(5-methoxy-1H-indol-3-yl) N
H
ethanamine
2-(5-Methoxy-1H-indol-3-yl)ethanamine (5- NH2

MM1373.01- Methoxytryptamine) O
608-07-1 25mg
0025 Related compound A (USP): 2-(5-methoxy-1H-indol-3-yl) N
H
ethanamine

Meloxicam
O O
S
N
MM0246.00- H
Meloxicam 71125-38-7 250mg N N

0250 OH O S

Impurity A (EP): Ethyl 4-Hydroxy-2-methyl-


O O
2H-1,2-benzothiazine-3-carboxylate 1,1- S
N
MM0084.03 Dioxide 24683-26-9 100mg O

Related compound A (USP): ethyl-4-hydroxy-2-methyl-2H- OH O

1,2-benzothiazine-3-carboxylate- 1,1-dioxide
Impurity A (EP): Ethyl 4-Hydroxy-2-methyl-
O O

MM0084.03- 2H-1,2-benzothiazine-3-carboxylate 1,1- S


N
Dioxide 24683-26-9 25mg O
0025 Related compound A (USP): ethyl-4-hydroxy-2-methyl-2H- OH O

1,2-benzothiazine-3-carboxylate- 1,1-dioxide
H 2N N
Impurity B (EP): 5-Methylthiazol-2-amine
MM0246.01
Related compound B (USP): 5-Methylthiazol-2-amine
7305-71-7 100mg S

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-373
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

H 2N N
MM0246.01- Impurity B (EP): 5-Methylthiazol-2-amine
Related compound B (USP): 5-Methylthiazol-2-amine
7305-71-7 25mg S
0025

O O

Impurity C (EP): N-[(2Z)-3,5-Dimethylthiazol-2(3H)- S


N

MM0246.16 ylidene]-4-hydroxy-2-methyl-2H-1,2-benzothiazine- 1262333-25-4 50mg N N

3-carboxamide 1,1-Dioxide OH O S

O O

Impurity D (EP): N-[(2Z)-3-Ethyl-5-methylthiazol- S


N

MM0246.17 2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2- n/a 50mg N N

benzothiazine-3-carboxamide 1,1-Dioxide OH O S

O O
Impurity E (EP): Methyl 4-Hydroxy-2-methyl- S
N
MM0084.02 2H-1,2-benzothiazine-3-carboxylate 1,1- 35511-15-0 100mg O
Dioxide OH O

O O

MM0084.02- Impurity E (EP): Methyl 4-Hydroxy-2-methyl- S


N
2H-1,2-benzothiazine-3-carboxylate 1,1- 35511-15-0 25mg O
0025 Dioxide OH O

Impurity F (EP): Isopropyl 4-Hydroxy-2-methyl-2H-


1,2-benzothiazine-3-carboxylate 1,1-Dioxide O O
S
(1-Methylethyl 4-Hydroxy-2-methyl-2H-1,2- N
O
benzothiazine-3-carboxylate 1,1-Dioxide)
MM0084.12 118854-48-1 100mg
Related compound C (USP): Isopropyl 4-hydroxy-2-methyl- OH O

2H-1,2-benzothiazine-3-carboxylate-1,1-dioxide
Impurity F (EP): Isopropyl 4-Hydroxy-2-methyl-2H-
1,2-benzothiazine-3-carboxylate 1,1-Dioxide O O
S
MM0084.12- (1-Methylethyl 4-Hydroxy-2-methyl-2H-1,2- N
O
benzothiazine-3-carboxylate 1,1-Dioxide)
118854-48-1 25mg
0025
Related compound C (USP): Isopropyl 4-hydroxy-2-methyl- OH O

2H-1,2-benzothiazine-3-carboxylate-1,1-dioxide
O O
S
4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxamide N
MM0084.09 24683-25-8 100mg NH2
1,1-Dioxide
OH O

O O
S
MM0084.09- 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxamide N
24683-25-8 25mg NH2
0025 1,1-Dioxide
OH O

O
O
S
1-Methylethyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl) N
MM0084.10 76508-37-7 100mg O
acetate O O

O
O
S
MM0084.10- 1-Methylethyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl) N
76508-37-7 25mg O
0025 acetate O O

O O
S
1-Methylethyl 4-Hydroxy-2H-1,2-benzothiazine-3-carboxylate NH
MM0084.11 76508-35-5 100mg O
1,1-Dioxide
OH O

O O
S
MM0084.11- 1-Methylethyl 4-Hydroxy-2H-1,2-benzothiazine-3-carboxylate NH
76508-35-5 25mg O
0025 1,1-Dioxide
OH O

O O
4-Methoxy-2-methyl-N-(5-methyl-1,3-thiazol-2-yl)-2H-1,2- S
N
MM0246.13- H
N N
benzothiazine-3-carboxamide 1,1-Dioxide (O- 1391051-96-9 25mg
0025 O O S
Methylmeloxicam; 4-Methoxymeloxicam)
O O
S
Methyl 4-Hydroxy-2H-1,2-benzothiazine-3-carboxylate 1,1- NH
MM0084.04 35511-14-9 100mg O
Dioxide
OH O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-374
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O O
S
MM0084.04- Methyl 4-Hydroxy-2H-1,2-benzothiazine-3-carboxylate 1,1- NH
35511-14-9 25mg O
0025 Dioxide
OH O

O
O
S
Methyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl) N
MM0084.07 6639-62-9 100mg O
acetate
O O

O
O
S
MM0084.07- Methyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl) N
6639-62-9 25mg O
0025 acetate
O O

O O
S
MM0084.27- OH

0025
2-Sulfobenzoic Acid 632-25-7 25mg OH

Melperone
O

MM0321.00 Melperone 3575-80-2 100mg N

O
MM0321.01- +
N
Melperone N-Oxide n/a 25mg O
0025 F

Melphalan
Cl

N HCl
Cl NH2
MM0824.02 Melphalan Hydrochloride 3223-07-2 100mg OH

H
MM0273.13 Impurity K (EP): N-Ethylethanamine (Diethylamine) 109-89-7 100mg N

Memantine Hydrochloride
NH2

MM1045.00 Memantine Hydrochloride 41100-52-1 250mg HCl

OH

MM1045.01- 1-Hydroxy-3,5-dimethyladamantane
Related compound B (USP): 3,5-Dimethyladamantane-1-ol
707-37-9 25mg
0025

Cl

MM1045.04- 1-Chloro-3,5-dimethyladamantane
Related compound C (USP): 1-Chloro-3,5- 707-36-8 25mg
0025 dimethyladamantane

Br
1-Bromo-3,5-dimethyladamantane
MM1045.05-
Related compound D (USP): 1-Bromo-3,5- 941-37-7 25mg
0025
dimethyladamantane

MM1045.06- 1,3-Dimethyladamantane
702-79-4 25mg
0025 Related compound A (USP): 1,3-Dimethyladamantane

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-375
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N-Formylmemantine NH
MM1045.07-
Related compound E (USP): N-3,5-Dimethyladamantan-1-yl 351329-88-9 25mg
0025
formamide

N H2
3-Methyladamantan-1-amine Hydrochloride
MM1045.08 (Desmethylmemantine Hydrochloride) 33103-93-4 100mg HCl

Related compound G (USP): 3-Methyladamantan-1-amine


N H2
3-Methyladamantan-1-amine Hydrochloride
MM1045.08-
(Desmethylmemantine Hydrochloride) 33103-93-4 25mg HCl
0025
Related compound G (USP): 3-Methyladamantan-1-amine
N H2
7-Methylmemantine Hydrochloride
MM1045.09- HCl
Related compound H (USP): 3,5,7-Trimethyladamantan-1- 15210-60-3 25mg
0025
amine

HN
MM1045.10-
N-Acetylmemantine 19982-07-1 25mg
0025

Menadione
O

MM3061.00 Menadione 58-27-5 250mg

Menthol Racemic
AND Enantiomer
OH

MM3006.00 Menthol Racemic 89-78-1 250mg

Mepacrine Hydrochloride
Cl
H
N
N

MM1695.00 Mepacrine Hydrochloride 69-05-6 250mg N

O
HCl
2

Cl
H O
N +
MM1695.02- N
N HCl
Mepacrine N-Oxide Dihydrochloride n/a 25mg 2

0025 O

Mepenzolate Bromide
+
N
O

MM1919.00 Mepenzolate Bromide 76-90-4 100mg OH


O Br

Meperidine Hydrochloride, see Pethidine Hydrochloride

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-376
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Mephenesin
OH
O OH
MM0810.00 Mephenesin 59-47-2 500mg

Mephenesin Carbamate
OH
O O N H2
MM3135.00 Mephenesin Carbamate 533-06-2 50mg O

Mephentermine Hemisulphate
H
N O

MM0740.00 Mephentermine Hemisulphate 1212-72-2 500mg HO S


O
OH

Mephobarbital, see Methylphenobarbital

Mepivacaine Hydrochloride
MM0368.00- H

Mepivacaine Hydrochloride 1722-62-9 250mg N


N
HCl

0250 O

N H2
MM0102.02 Impurity A (EP): 2,6-Dimethylaniline 87-62-7 100mg

H
Impurity B (EP): (RS)-N-(2,6-Dimethylphenyl)piperidine-2- N
MM0368.08 15883-20-2 100mg N
carboxamide O
H

H
MM0368.08- Impurity B (EP): (RS)-N-(2,6-Dimethylphenyl)piperidine-2- N
15883-20-2 25mg N
0025 carboxamide O
H

MM0368.02- Impurity B (EP) as Hydrochloride: (RS)-N-(2,6- H


N HCl
Dimethylphenyl)piperidine-2-carboxamide 65797-42-4 25mg N
H
O
0025 Hydrochloride

H
Impurity C (EP): N-(2,6-Dimethylphenyl)- N
MM0368.03 39627-98-0 100mg N
pyridine-2-carboxamide O

H
MM0368.03- Impurity C (EP): N-(2,6-Dimethylphenyl)- N
39627-98-0 25mg N
0025 pyridine-2-carboxamide O

MM0368.07- Impurity E (EP): (RS)-N-(4-Chloro-2,6-dimethyl- H


N
N
n/a 25mg
0025 phenyl)-1-methylpiperidine-2-carboxamide O
Cl

H
N
MM0368.06 Mepivacaine N-Oxide 1346597-75-8 100mg N
+

O
O

Meprednisone
O

OH
O OH

MM3686.00 Meprednisone 1247-42-3 250mg H

H H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-377
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Meprobamate
O O

H 2N O O NH2
MM0929.00 Meprobamate 57-53-4 CS 50mg

Meprotixol
N
OH

MM3133.00 Meprotixol 4295-63-0 100mg S

Meptazinol Hydrochloride
N
MM3132.00 Meptazinol Hydrochloride 59263-76-2 100mg OH
HCl

Mepyramine Maleate (Pyrilamine Maleate)


O
N
N

MM0559.00 Mepyramine Maleate 59-33-6 500mg O N


OH
OH

NH
Impurity A (EP): N-(4-Methoxybenzyl)pyridin-
MM0559.02 52818-63-0 100mg O N
2-amine

NH
MM0559.02- Impurity A (EP): N-(4-Methoxybenzyl)pyridin-
52818-63-0 25mg O N
0025 2-amine

Impurity B (EP): 4-Methoxybenzaldehyde O


MM0164.03 123-11-5 100mg
(Anisaldehyde) O

NH2

MM0084.01 Impurity C (EP): Pyridin-2-amine 504-29-0 100mg N

NH2
MM0084.01-
Impurity C (EP): Pyridin-2-amine 504-29-0 25mg N
0025

+O O
N
MM0559.06- N
OH

Mepyramine N-Oxide Maleate n/a 25mg O N OH

0025 O

Mequinol
O

MM1131.00 Mequinol 150-76-5 500mg


HO

Mequitazine
AND Enantiomer

MM3131.00 Mequitazine 29216-28-2 100mg N


H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-378
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

AND Enantiomer

+
N O
H
MM3131.01 Mequitazine N-Oxide n/a 100mg N

AND Enantiomer

N
H
MM3131.02 Mequitazine Sulfoxide 40765-34-2 100mg N

S
O

AND Enantiomer

N
MM3131.02- H
Mequitazine Sulfoxide 40765-34-2 25mg N
0025
S
O

AND Enantiomer

+ O
N
MM3131.04- H
Mequitazine Sulfoxide N-Oxide (Mequitazine N,S-Dioxide) 62705-13-9 25mg N
0025
S
O

AND Enantiomer

N O
+

MM3131.05- H
Mequitazine Sulfone N-Oxide (Mequitazine N,S,S-Trioxide) n/a 25mg N
0025
S
O O

Mercaptopurine
SH
H
MM1537.00- N
Mercaptopurine Monohydrate 6112-76-1 250mg N
H2 O
0250 N
N

N
HN
MM1047.01 Impurity A (EP): 1,7-Dihydro-6H-purin-6-one (Hypoxanthine) 68-94-0 100mg
N N
H

N
MM1047.01- HN
Impurity A (EP): 1,7-Dihydro-6H-purin-6-one (Hypoxanthine) 68-94-0 25mg
0025
N N
H

Meropenem Trihydrate
O
+
N
O
O
(4-Nitrophenyl)methyl (4R,5R,6S)-3- O
O
MM1327.03- N
O
Diphenoxyphosphoryloxy-6-[(1R)-1-hydroxyethyl]-4-methyl-7- 90776-59-3 25mg O
P
0025 HO H H O
O
oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate

Mesalamine, see Mesalazine

Mesalazine (Mesalamine)
O
MM0217.00- H 2N
Mesalazine 89-57-6 250mg OH
0250
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-379
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

H 2N

MM0042.01 Impurity A (EP): 4-Aminophenol 123-30-8 100mg


OH

H 2N
MM0042.01-
Impurity A (EP): 4-Aminophenol 123-30-8 25mg
0025 OH

MM0042.07 Impurity B (EP): 3-Aminophenol 591-27-5 100mg


H2 N OH

MM0217.06 Impurity C (EP): 2-Aminophenol 95-55-6 100mg OH


NH2

MM0217.06-
Impurity C (EP): 2-Aminophenol 95-55-6 25mg OH
0025
NH2

OH
MM0217.07 Impurity D (EP): 3-Aminobenzoic Acid 99-05-8 100mg

NH2

MM0217.07- OH
Impurity D (EP): 3-Aminobenzoic Acid 99-05-8 25mg
0025
NH2

Impurity F (EP): 3-Amino-2-hydroxybenzoic OH


MM0217.09 570-23-0 100mg
Acid (3-Aminosalicylic Acid) OH
NH2

MM0217.09- Impurity F (EP): 3-Amino-2-hydroxybenzoic OH


570-23-0 25mg
0025 Acid (3-Aminosalicylic Acid) OH
NH2

O
HO
MM0217.10 Impurity G (EP): 2,5-Dihydroxybenzoic Acid 490-79-9 100mg OH

OH

O
MM0217.10- HO
Impurity G (EP): 2,5-Dihydroxybenzoic Acid 490-79-9 25mg OH
0025
OH

MM0045.00- OH
Impurity H (EP): 2-Hydroxybenzoic Acid (Salicylic Acid) 69-72-7 250mg
0250
OH

O
Impurity I (EP): 2-Hydroxy-5-(phenyldiazenyl)benzoic N
N
OH
MM0217.12 3147-53-3 50mg
Acid (Phenylazosalicylic Acid) OH

H2 N
HCl
MM0093.17 Impurity K (EP) as Hydrochloride: Aniline Hydrochloride 142-04-1 100mg

MM0217.14 Impurity L (EP): 2-Chlorobenzoic Acid 118-91-2 100mg OH

Cl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-380
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0217.14-
Impurity L (EP): 2-Chlorobenzoic Acid 118-91-2 25mg OH
0025
Cl

O O
+
N
MM0217.15 Impurity M (EP): 2-Chloro-5-nitrobenzoic Acid 2516-96-3 100mg O OH

Cl

O O
+
MM0217.15- N
Impurity M (EP): 2-Chloro-5-nitrobenzoic Acid 2516-96-3 25mg O OH
0025 Cl

O O
+
Impurity N (EP): 2-Hydroxy-5-nitrobenzoic Acid O
N
OH
MM0217.16 96-97-9 100mg
(5-Nitrosalicylic Acid) OH

O O
+
MM0217.16- Impurity N (EP): 2-Hydroxy-5-nitrobenzoic Acid O
N
OH
96-97-9 25mg
0025 (5-Nitrosalicylic Acid) OH

H 2N
Impurity O (EP): 4-Aminobenzenesulfonic Acid (Sulfanilic OH
MM0227.04 121-57-3 100mg
Acid) S
O O

H 2N
MM0227.04- Impurity O (EP): 4-Aminobenzenesulfonic Acid (Sulfanilic OH
121-57-3 25mg
0025 Acid) S
O O

Impurity O (EP) as Sodium Salt Dihydrate: 4-


NH2
MM3472.04- Aminobenzenesulfonic Acid Sodium Salt Dihydrate (Sodium +
Na O H2O
6106-22-5 100mg S 2
0100 4-Aminobenzenesulfonate Dihydrate; Sulfanilic Acid Sodium O O

Salt Dihydrate)
O OH

OH
MM0217.02 5-Acetaminosalicylic Acid 51-59-2 100mg O

N
H

O OH

MM0217.02- OH
5-Acetaminosalicylic Acid 51-59-2 25mg O
0025
N
H

O
H 2N
MM0217.25 42753-75-3 100mg O
Mesalazine Methyl Ester
OH

O
MM0217.25- H 2N
42753-75-3 25mg O
Mesalazine Methyl Ester
0025 OH

O
H2 N
O
MM0217.26 Mesalazine Ethyl Ester 62773-65-3 100mg
OH

O
MM0217.26- H2 N
O
Mesalazine Ethyl Ester 62773-65-3 25mg
0025 OH

O
H2 N
O
MM0217.27 Mesalazine Isopropyl Ester 64240-87-5 50mg
OH

Mesna
O O
MM0345.00 Mesna 19767-45-4 250mg HS
S
O Na
+

Impurity A (EP): 2-(Carbaminidoylsulfanyl)ethanesulfonic NH O O


MM0345.01 25985-57-3 100mg S
Acid H 2N S OH

MM0345.01- Impurity A (EP): 2-(Carbaminidoylsulfanyl)ethanesulfonic NH O O


25985-57-3 25mg S
0025 Acid H 2N S OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-381
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0345.02- Impurity B (EP): 2-[[(Guanidino)(imino)methyl]sulfanyl] NH NH O O


S
1391053-66-9 25mg H 2N N S OH
0025 ethanesulfonic Acid H

NH2
MM0345.05- Impurity E (EP): 2-(4,6-Diamino-1,3,5-triazin-2-yl) N N O O
1391054-56-0 25mg
0025 sulfanylethanesulfonic Acid H 2N N S
S
OH

Mesoridazine Besilate

N N
MM0116.08- 10-[2-[(2RS)-1-Methylpiperidin-2-yl]ethyl]-2-(methylsulfinyl)- S
53926-89-9 25mg O
0025 10H-phenothiazine 5-Oxide (Mesoridazine 5-Sulfoxide)
S
O

N N
MM0116.11- 10-[2-[(2RS)-1-Methylpiperidin-2-yl]ethyl]-2-(methylsulfonyl)- O S
100574-22-9 25mg O
0025 10H-phenothiazine 5,5-Dioxide (Sulforidazine 5-Sulfone)
S
O O

+
N N
MM3617.02- Mesoridazine 5-Sulfoxide N-Oxide (Mesoridazine N,S5- S O
n/a 25mg O
0025 Dioxide)
S
O

Mesterolone
OH

H
MM0495.00 Mesterolone 1424-00-6 100mg H H
O
H

Mestranol
OH

H
MM1698.00 Mestranol 72-33-3 250mg H H
O

Metacresol
OH

MM1132.02 Metacresol (3-Methylphenol) 108-39-4 250mg

Metacycline Hydrochloride
OH O OH O O
OH
N H2

MM0874.00 Metacycline Hydrochloride 3963-95-9 250mg H H


OH
OH N HCl

Metamizole Sodium Monohydrate


O O O
N S +
MM0052.00- N
O Na
Metamizole Sodium Monohydrate 5907-38-0 250mg N
0250 H2O

O
Impurity A (EP): 4-Formylamino-1,5-dimethyl- H
N O

MM0052.02 2-phenyl-1,2-dihydro-3H-pyrazol-3-one 1672-58-8 100mg N


N
(4-Formylaminophenazone)
O

MM0052.02- Impurity A (EP): 4-Formylamino-1,5-dimethyl- H


N O

2-phenyl-1,2-dihydro-3H-pyrazol-3-one 1672-58-8 25mg N


N
0025 (4-Formylaminophenazone)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-382
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
Impurity B (EP): 4-Amino-1,5-dimethyl-2-
MM0052.04 phenyl-1,2-dihydro-3H-pyrazol-3-one 83-07-8 100mg N
N H2
N
(Ampyrone)

O
MM0052.04- Impurity B (EP): 4-Amino-1,5-dimethyl-2-
phenyl-1,2-dihydro-3H-pyrazol-3-one 83-07-8 25mg N
N H2
N
0025 (Ampyrone)

Impurity C (EP) as Hydrochloride: O H


N
4-Methylamino-1,5-dimethyl-2-phenyl-1,2- N
MM0052.10 856307-27-2 100mg HCl
dihydro-3H-pyrazol-3-one Hydrochloride N

(4-Methylaminophenazone Hydrochloride)
Impurity C (EP) as Hydrochloride: O H
N
MM0052.10- 4-Methylamino-1,5-dimethyl-2-phenyl-1,2- N
856307-27-2 25mg HCl
0025 dihydro-3H-pyrazol-3-one Hydrochloride N

(4-Methylaminophenazone Hydrochloride)
O
Impurity D (EP): 4-Dimethylamino-1,5-dimethyl- N

MM0052.05 2-phenyl-1,2-dihydro-3H-pyrazol-3-one 58-15-1 100mg N


N
(4,4-Dimethylaminophenazone)
Impurity E (EP) as Sodium Salt: [(1,5-Dimethyl-3-oxo-2- O H
N
O
S
O
Na
+

O
MM0052.11 phenyl-2,3-dihydro-1H-pyrazol-4-yl)amino]methanesulfonic 129-89-5 100mg N
N

Acid Sodium Salt (4-N-Desmethylmetamizole Sodium Salt)

MM0052.11- Impurity E (EP) as Sodium Salt: [(1,5-Dimethyl-3-oxo-2- O H


N
O
S
O
Na
+

O
phenyl-2,3-dihydro-1H-pyrazol-4-yl)amino]methanesulfonic 129-89-5 25mg N
N
0025 Acid Sodium Salt (4-N-Desmethylmetamizole Sodium Salt)
O H
N O

MM0052.01 4-Acetylaminophenazone 83-15-8 100mg N


N

O H
N O
MM0052.01-
4-Acetylaminophenazone 83-15-8 25mg N
N
0025

O
MM0052.50- N
4-Benzylideneaminoantipyrine 83-17-0 25mg N
N
0025

Metapramine Fumarate

MM3977.01-
N-Methyliminostilbene (N-Methyl-2,2'-iminostilbene) 52249-32-8 25mg N
0025

Metaproterenol Sulfate, see Orciprenaline Sulphate

Metaraminol Bitartrate
OH O OH

MM1797.00 Metaraminol Bitartrate 33402-03-8 250mg


HO

N H2
HO
OH O
OH

Metaxalone
H
N
O
MM3650.00- O
Metaxalone 1665-48-1 250mg O

0250

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-383
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Metformin Hydrochloride
NH NH

MM0056.00 Metformin Hydrochloride 1115-70-4 500mg H2 N N


H
N HCl

H
Impurity A (EP): Cyanoguanidine H 2N N
MM0056.01
Related compound A (USP): 1-Cyanoguanidine
461-58-5 100mg N
NH

H
MM0056.01- Impurity A (EP): Cyanoguanidine H 2N N
Related compound A (USP): 1-Cyanoguanidine
461-58-5 25mg N
0025 NH

N H2

Impurity B (EP) as Nitrate: (4,6-Diamino-1,3,5- N N NH HO N


O
+
MM0056.07 3553-49-9 100mg
triazin-2-yl)guanidine Nitrate H 2N N N
H
N H2
O

N H2

MM0056.07- Impurity B (EP) as Nitrate: (4,6-Diamino-1,3,5- N N NH HO N


O
+
3553-49-9 25mg
0025 triazin-2-yl)guanidine Nitrate H 2N N N
H
N H2
O

Impurity C (EP): N,N-Dimethyl-1,3,5-triazine- H 2N N N


2,4,6-triamine
1985-46-2 100mg N N
Related compound C (USP): N,N-Dimethyl-[1,3,5]triazine-
MM0056.03
2,4,6-triamine N H2

Impurity C (EP): N,N-Dimethyl-1,3,5-triazine- H 2N N N


MM0056.03- 2,4,6-triamine
1985-46-2 25mg N N
0025 Related compound C (USP): N,N-Dimethyl-[1,3,5]triazine-
2,4,6-triamine N H2

H 2N N NH2

Impurity D (EP): 1,3,5-Triazine-2,4,6-triamine N N


MM0056.04 108-78-1 100mg
(Melamine)
NH2

H 2N N NH2
MM0056.04- Impurity D (EP): 1,3,5-Triazine-2,4,6-triamine N N
108-78-1 25mg
0025 (Melamine)
NH2

Impurity E (EP) as Hydrochloride: 1-Methylbiguanide NH NH


HCl
MM0056.05 Hydrochloride 1674-62-0 100mg H 2N N
H
N
H
Related compound B (USP): 1-Methylbiguanide

MM0056.05- Impurity E (EP) as Hydrochloride: 1-Methylbiguanide NH NH


HCl
Hydrochloride 1674-62-0 25mg H 2N N
H
N
H
0025 Related compound B (USP): 1-Methylbiguanide
Impurity F (EP) as Hydrochloride: N-Methyl- H
MM0056.06 506-59-2 100mg N HCl
methanamine Hydrochloride
N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20

Methacholine Chloride
O

MM3470.00 Methacholine Chloride 62-51-1 250mg O


+
Cl
N

Methadone Hydrochloride
N

MM0531.00-
Methadone Hydrochloride 1095-90-5 CS 250mg HCl

0250 O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-384
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N
Impurity B (EP): (4RS)-4-(Dimethylamino)-2,2-
diphenylpentanenitrile (Didiavalo; Premethadone; Methadone
MM0531.09 125-79-1 CS 100mg
Nitrile) N
Related compound B (USP)

N
Impurity B (EP): (4RS)-4-(Dimethylamino)-2,2-
MM0531.09- diphenylpentanenitrile (Didiavalo; Premethadone; Methadone
125-79-1 CS 25mg
0025 Nitrile) N
Related compound B (USP)

Impurity C (EP): (3RS)-4-(Dimethylamino)-3-methyl-2,2-


MM0531.12 diphenylbutanenitrile (Isodidiavalo) 6293-01-2 50mg
Related compound C (USP) N

N
Impurity C (EP) as Hydrochloride: (3RS)-4-(Dimethyl-
amino)-3-methyl-2,2-diphenylbutanenitrile Hydro- HCl
MM0531.04
chloride (Isodidiavalo Hydrochloride)
63867-26-5 50mg
N

Related compound C (USP)


N
Impurity D (EP) as Hydrochloride: (5RS)-6-(Dimethyl-)-5-
methyl-4,4-diphenylhexan-3-one Hydro-(Isomethadone HCl
MM0531.05 5341-49-1 CS 25mg
Hydrochloride) O
Related compound D (USP)
N

MM0531.06 Impurity E (EP): Diphenylacetonitrile 86-29-3 100mg

MM0531.06-
Impurity E (EP): Diphenylacetonitrile 86-29-3 25mg
0025

MM0531.13- HCl
N,N,2-Trimethyl-3,3-diphenylpropan-1-amine Hydrochloride 63905-14-6 25mg
0025

Methamphetamine Hydrochloride
H
N
MM0964.00 Methamphetamine Hydrochloride 51-57-0 CS 100mg HCl

H
N
MM0964.03 rac-Methamphetamine Hydrochloride 300-42-5 CS 100mg HCl

H
MM0964.03- N
rac-Methamphetamine Hydrochloride 300-42-5 CS 25mg HCl
0025

Methapyrilene Hydrochloride
S
HCl

MM1680.00 Methapyrilene Hydrochloride 135-23-9 250mg N N


N

MM1680.01-
Methapyrilene N-Oxide 78761-79-2 25mg N N +
0025 N
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-385
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Methaqualone Hydrochloride
N

N
MM1356.00 Methaqualone 72-44-6 CS 100mg
O

N
MM1356.02 Etaqualone (3-(2-Ethylphenyl)-2-methyl--one) 7432-25-9 100mg
O

MM1356.02- N
Etaqualone (3-(2-Ethylphenyl)-2-methyl--one) 7432-25-9 25mg
0025 O

Metharbital
H
O N O

MM1656.00 Metharbital 50-11-3 100mg N

Methenamine
N

MM1998.00 Methenamine 100-97-0 250mg N N


N

O
MM1998.01- N+
Methenamine N-Oxide 62190-92-5 25mg
0025 N N
N

Methenolone
OH

H
MM1374.00 Methenolone 153-00-4 100mg H H
O
H

Methenolone Acetate
O

MM3720.00 Methenolone Acetate 434-05-9 250mg H

H H
O
H

OH

H
MM1374.00 Methenolone 153-00-4 100mg H H
O
H

Methenolone Enantate
O

MM3721.00 Methenolone Enantate 303-42-4 250mg H


H

H
O
H

OH

H
MM1374.00 Methenolone 153-00-4 100mg H H
O
H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-386
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Methimazole, see Thiamazole

Methionine
NH2
MM0358.00- OH
Methionine (L-Methionine) 63-68-3 250mg S
0250 O

NH2
Impurity A (EP): (2S)-2-Amino-4-[(RS)-methylsulfinyl] OH
MM0358.05 3226-65-1 100mg S
butanoic Acid (L-Methionine Sulfoxide) O O

NH2
MM0358.05- Impurity A (EP): (2S)-2-Amino-4-[(RS)-methylsulfinyl] OH
3226-65-1 25mg S
0025 butanoic Acid (L-Methionine Sulfoxide) O O

NH2
Impurity B (EP): (2S)-2-Amino-4-(methylsulfonyl)butanoic OH
MM0358.06 7314-32-1 100mg S
Acid (L-Methionine Sulfone) O O O

NH2
MM0358.06- Impurity B (EP): (2S)-2-Amino-4-(methylsulfonyl)butanoic OH
7314-32-1 25mg S
0025 Acid (L-Methionine Sulfone) O O O

Impurity C (EP): (2RS)-2-(Acetylamino)-4-(methylsulfanyl) NH


MM0358.07 1115-47-5 100mg OH
butanoic Acid (N-Acetyl-DL-methionine) S
O

MM0358.07- Impurity C (EP): (2RS)-2-(Acetylamino)-4-(methylsulfanyl) NH


1115-47-5 25mg OH
0025 butanoic Acid (N-Acetyl-DL-methionine) S
O

Impurity C (EP) as (S)-Enantiomer: (2S)-2-(Acetylamino)-4- NH


MM0358.04 65-82-7 100mg
(methylsulfanyl)butanoic Acid (N-Acetyl-L-Methionine) S
OH

MM0358.04- Impurity C (EP) as (S)-Enantiomer: (2S)-2-(Acetylamino)-4- NH

(methylsulfanyl)butanoic Acid (N-Acetyl-L-Methionine)


65-82-7 25mg OH
0025 S
O

DL-Methionine (Racemethionine)
NH2
MM0879.00- OH
DL-Methionine (Racemethionine) 59-51-8 250mg S
0250 O

Methocarbamol
OH
O O NH2
MM1061.00 Methocarbamol 532-03-6 250mg O
O

O
MM0354.09- O
4-[(2-Methoxyphenoxy)methyl]-1,3-dioxolan-2-one 2049-21-0 25mg O
0025
O

Methohexital

O N O

MM1347.00 Methohexital 151-83-7 100mg NH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-387
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Methomyl
O
N
MM2523.00 Methomyl 16752-77-5 250mg O N
H
S

Methotrexate
O OH
O

MM0040.00 Methotrexate 59-05-2 500mg N


N H2
N
N
N
H

OH
O

H 2N N N

NH2
Impurity A (EP) as Hydrochloride: (2,4-Diaminopteridin- N
N
OH HCl
MM0040.08 73978-41-3 100mg
6-yl)methanol Hydrochloride H 2N N N

NH2
MM0040.08- Impurity A (EP) as Hydrochloride: (2,4-Diaminopteridin- N
N
OH HCl
73978-41-3 25mg
0025 6-yl)methanol Hydrochloride H 2N N N

Impurity B (EP): (2S)-2-[[4-[[(2,4-Diaminopteridin-6-yl)methyl]


amino]benzoyl]amino]pentanedioic Acid (4-Aminofolic Acid, O
O OH

Aminopterin)
N H2 N
H
N O
MM0040.05 54-62-6 100mg N N
H
OH

Related compound B (USP): (S)-2-4-[(2,4-diaminopteridin- H 2N N N

6-yl)methylamino]benzamidopentanedioic acid
Impurity B (EP): (2S)-2-[[4-[[(2,4-Diaminopteridin-6-yl)methyl]
MM0040.05- amino]benzoyl]amino]pentanedioic Acid (4-Aminofolic Acid, O
O OH

Aminopterin)
N H2 N
H
N O
54-62-6 25mg N N
H
OH
0025 Related compound B (USP): (S)-2-4-[(2,4-diaminopteridin- H 2N N N

6-yl)methylamino]benzamidopentanedioic acid
Impurity C (EP): (2S)-2-[[4-[[(2-Amino-4-oxo-1,4-
dihydropteridin-6-yl)methyl]methylamino]benzoyl]amino] O
O OH

MM0040.06 pentanedioic Acid (N-Methylfolic Acid, Methopterin) 2410-93-7 50mg N


O
N
N
N
H
O

Related compound C (USP): (S)-2-(4-[(2-amino-4-oxo-1,4- H2 N N


H
N
OH

dihydropteridin-6-yl)methyl](methyl)aminobenzamido)
pentanedioic acid
O
Impurity E (EP): 2,4-Diamino-N10-methylpteroic Acid (APA)
MM0040.02- NH2 OH
N
Related compound E (USP): 4-[(2,4-Diaminopteridin-6-yl) 19741-14-1 25mg N N

0025 H2 N N N
methyl](methyl)aminobenzoic acid
O
Impurity G (EP) as Hydrochloride: (2S)-2-[[4-[[4-[[(2,4- NH2 N
MM0040.33- N
N
N
O OH

HCl
Diaminopteridin-6-yl)methyl]methylamino]benzoyl] n/a 25mg H 2N N N

O N
OH
0025 H
O

methylamino]benzoyl]amino]pentanedioic Acid Hydrochloride


Impurity H (EP): (2S)-2-[[4-[[(2,4-Diaminopteridin-6-yl)methyl] O OH
O

MM0040.23- methylamino]benzoyl]amino]-5-methoxy-5-oxopentanoic Acid N H2


N
N
H
O

(Methotrexate 5-Methyl Ester)


67022-39-3 25mg N N
O
0025 H 2N N N

Related compound H (USP)


Impurity J (EP): Dimethyl (2S)-2-[[4-[[(2,4-Diaminopteridin-6- O O
O

MM0040.25- N H2 N
H
N O
yl)methyl]methylamino]benzoyl]amino]pentanedioate 34378-65-9 25mg N N
O
0025 H 2N N N

(Methotrexate Dimethyl Ester)


O OH
O

MM0621.01- Impurity K (EP): (2S)-2-[(4-Aminobenzoyl)amino] N


H
4271-30-1 25mg
0025 pentanedioic Acid (N-(4-Aminobenzoyl)-L-glutamic Acid) H 2N
OH

O O
N
MM0621.09- N
6-Formylpterin 712-30-1 25mg
0025 H 2N N N
H

O O
N O

MM0040.13- NH2 N
H
N O
e Methotrexate Diethyl Ester 43170-88-3 25mg N N
O
H2 N N N

w
0025

NH2
MM0040.16- NH2 O O
N
2,4,5,6-Tetraaminopyrimidine Sulfate 5392-28-9 25mg S
HO OH
0025 H 2N N N H2

NH2
HO OH
MM1333.00 Glutamic Acid (L-Glutamic Acid) 56-86-0 250mg
O O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-388
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Methoxsalen
O
O O
MM0555.00 Methoxsalen 298-81-7 500mg O

Methoxyphenamine Hydrochloride
H
N

MM0655.00 Methoxyphenamine Hydrochloride 5588-10-3 500mg O


HCl

Methsuximide
O

N
MM3137.00 Methsuximide 77-41-8 100mg
O

Methyl Nicotinate
O

MM0549.00 Methyl Nicotinate 93-60-7 500mg N O

O
MM0553.00-
Impurity A (EP): Nicotinic Acid 59-67-6 250mg N OH
0250

Methyl Parahydroxybenzoate
O
MM0431.00- O
Methyl Parahydroxybenzoate 99-76-3 250mg
0250 HO

O
MM0045.01-
Impurity A (EP): 4-Hydroxybenzoic Acid 99-96-7 250mg OH
0250
HO

O
MM0498.00- Impurity B (EP): Ethyl 4-Hydroxybenzoate (Ethyl O
120-47-8 250mg
0250 Parahydroxybenzoate) HO

O
MM0432.00- Impurity C (EP): Propyl 4-Hydroxybenzoate O
94-13-3 250mg
0250 (Propyl Parahydroxybenzoate) HO

O
Impurity D (EP): Butyl 4-Hydroxybenzoate O
MM0496.00 94-26-8 500mg
(Butyl Parahydroxybenzoate) HO

O
MM0431.01 Sodium Methyl Parahydroxybenzoate 5026-62-0 500mg
+ O
Na

Methyl Salicylate
O

MM1063.00 Methyl Salicylate 119-36-8 250mg O

OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-389
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
MM0045.11 Impurity B (EP): Phenol 108-95-2 100mg

O
MM0431.00- Impurity C (EP): Methyl 4-Hydroxybenzoate (Methyl O
99-76-3 250mg
0250 Parahydroxybenzoate)
HO

MM1063.01 O
Impurity D (EP): Methyl 4-Methoxybenzoate 121-98-2 100mg
O

O
MM1063.01- O
Impurity D (EP): Methyl 4-Methoxybenzoate 121-98-2 25mg
0025 O

MM0045.16 Impurity F (EP): Ethyl 2-Hydroxybenzoate (Ethyl Salicylate) 118-61-6 100mg O

OH

MM1063.02 Impurity M (EP): Methyl 2-Methoxybenzoate 606-45-1 100mg O

Methylbenzethonium Chloride
+
O N

MM3151.00 Methylbenzethonium Chloride 25155-18-4 250mg O


Cl

Methylchloroisothiazolinone
Cl
S
MM0877.06- Methylchloroisothiazolinone (N-Methyl-5- N
26172-55-4 100mg
0100 chloroisothiazolone; 5-Chloro-2-methyl-4-isothiazolin-3-one)
O

Cl
S
MM3820.01- N
4,5-Dichloro-2-methylisothiazol-3-one 26542-23-4 25mg
0025 Cl
O

Methyldopa
O

OH

MM0643.00 Methyldopa Sesquihydrate 41372-08-1 250mg HO


N H2 H2O
3

OH
2

Methyl (2S)-2-Amino-3-(3,4-dihydroxyphenyl)-2- O

MM1501.22- O
methylpropanoate Hydrochloride (Methyldopa Methyl Ester 115054-62-1 25mg H 2N HCl
HO
0025 OH
Hydrochloride)

Methylergometrine Maleate
O

HO N
Impurity A (EP): (6aR,9R)-7-Methyl-4,6,6a,7,8,9- H

MM1346.03 hexahydroindolo[4,3-fg]quinoline-9-carboxylic Acid (Lysergic 82-58-6 100mg


Acid)
N
H

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-390
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

HO N

MM1346.03- Impurity A (EP): (6aR,9R)-7-Methyl-4,6,6a,7,8,9- H

hexahydroindolo[4,3-fg]quinoline-9-carboxylic Acid (Lysergic 82-58-6 25mg


0025 Acid)
N
H

Methylhyoscine Bromide (Methscopolamine Bromide)


H H
O
MM3882.01- Apomethscopolamine Bromide (N- H
N
+
O Br
109668-57-7 25mg O
H
0025 Methylaposcopolammonium Bromide) H

Methylphenidate Hydrochloride
AND Enantiomer
O O
MM1031.00-
Methylphenidate Hydrochloride 23655-65-4 CS 250mg H
N
HCl

0250 H

AND Enantiomer
O NH2
MM1031.05- Impurity C (EP): (2RS)-2-Phenyl-2-[(2RS)-piperidin-2-yl] H
50288-62-5 25mg N
H
0025 acetamide

AND Enantiomer
Impurity E (EP) as Hydrochloride: Ethyl (2RS)-Phenyl[(2RS)- O O
H HCl
MM1031.09 piperidin-2-yl]acetate Hydrochloride (Ethylphenidate 19716-79-1 CS 100mg N
H

Hydrochloride)
AND Enantiomer
Impurity E (EP) as Hydrochloride: Ethyl (2RS)-Phenyl[(2RS)- O O
MM1031.09- H HCl
piperidin-2-yl]acetate Hydrochloride (Ethylphenidate 19716-79-1 CS 25mg N

0025 H

Hydrochloride)
O NH2

N
MM1031.08 Impurity F (EP): (2RS)-2-Phenyl-2-(pyridin-2-yl)acetamide 7251-52-7 100mg

O NH2

MM1031.08- N
Impurity F (EP): (2RS)-2-Phenyl-2-(pyridin-2-yl)acetamide 7251-52-7 25mg
0025

O OH
Ritalinic Acid H
N
MM1031.04 Related compound A (USP): alpha-Phenyl-2- 19395-41-6 100mg
piperidineacetic Acid

O OH
Ritalinic Acid H
MM1031.04- N
Related compound A (USP): alpha-Phenyl-2- 19395-41-6 25mg
0025 piperidineacetic Acid
O OH
Ritalinic Acid Hydrochloride H
N HCl
MM1031.11 Related compound A (USP): alpha-Phenyl-2-piperidineacetic 19395-40-5 100mg
Acid
O OH
Ritalinic Acid Hydrochloride H
MM1031.11- N HCl
Related compound A (USP): alpha-Phenyl-2-piperidineacetic 19395-40-5 25mg
0025 Acid
Cl N
MM1031.17 2-Chloropyridine 109-09-1 100mg

O O

MM1031.18- N
Methyl 2-Phenyl-2-(pyridin-2-yl)acetate 26483-64-7 25mg
0025

O
MM0160.03 Phenylacetic Acid 103-82-2 100mg
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-391
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0160.03- O
Phenylacetic Acid 103-82-2 25mg
0025 OH

MM0269.05- N
Phenylacetonitrile (Benzyl Cyanide) 140-29-4 100mg
0100
AND Enantiomer

MM1031.23- (aRS,2RS)-Isopropylphenidate Hydrochloride ((±)-threo- O O


1262795-94-7 25mg H H HCl
N
0025 Isopropylphenidate Hydrochloride)

Methylphenobarbital (Mephobarbital)

O N O

MM1700.00 Methylphenobarbital 115-38-8 CS 250mg NH

Methylprednisolone
O
OH
HO OH
MM0190.00- H
Methylprednisolone 83-43-2 250mg H H
0250 O

O
Impurity A (EP): 17,21-Dihydroxy-6 - O
OH
OH
MM0190.01- methylpregna-1,4-diene-3,11,20-trione H
91523-05-6 25mg
0025 Related compound A (USP): 17,21-Dihydroxy-6alpha- O
H H

methylpregna-1,4-diene-3,11,20-trione
O
O
Impurity J (EP): 11 ,17-Dihydroxy-6 -methyl-3,20- O
HO OH
MM0191.00- H
dioxopregna-1,4-dien-21-yl Acetate (Methylprednisolone 53-36-1 250mg H H
0250 O
Acetate)
O
OH
HO OH
MM0193.00- Impurity K (EP): 11 ,17,21-Trihydroxypregna-1,4-diene-3,20- H
50-24-8 250mg
0250 H H
dione (Prednisolone) O

Methylprednisolone Acetate
O
O
O
HO OH
MM0191.00-
Methylprednisolone Acetate 53-36-1 250mg H
H

H
0250 O

O
OH
HO OH
MM0190.00- Impurity B (EP): 11 ,17,21-Trihydroxy-6 -methylpregna-1,4- H
83-43-2 250mg H H
0250 diene-3,20-dione (Methylprednisolone) O

O
O
O
MM0194.00- Impurity E (EP): 11 ,17-Dihydroxy-3,20-dioxopregna-1,4- HO OH
H
52-21-1 250mg
0250 dien-21-yl Acetate (Prednisolone Acetate) H H
O

Methylprednisolone Hydrogen Succinate


O
O
OH
O
HO OH
O

MM1515.00 Methylprednisolone Hydrogen Succinate 2921-57-5 250mg H


H

H
O

O
O +
O Na

Methylprednisolone Hydrogen HO
H
OH
O
O

MM0192.00
Succinate Sodium Salt
2375-03-3 request H H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-392
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
OH
HO OH
MM0190.00- H
Impurity A (EP): Methylprednisolone 83-43-2 250mg H H
0250 O

O
O
O
HO OH
MM0191.00-
Impurity C (EP): Methylprednisolone Acetate 53-36-1 250mg H
H

H
0250 O

N-Methylpyrrolidone

N O
MM3004.00 N-Methylpyrrolidone 872-50-4 250mg

Methylsulfonal
O O O O
S S
MM3149.00 Methylsulfonal 76-20-0 100mg

Methyltestosterone
OH

H
MM0558.00 Methyltestosterone 58-18-4 250mg
H H
O

OH

MM0323.00- H
Testosterone 58-22-0 250mg
0250 H H
O

Methylthiouracil
H
N S

MM3148.00 Methylthiouracil 56-04-2 100mg NH

Metixene Hydrochloride

MM0125.00 Metixene Hydrochloride Monohydrate 7081-40-5 250mg S


N
HCl H2 O

MM0125.01 Impurity A (EP): 9H-Thioxanthene 261-31-4 100mg S

MM0125.01-
Impurity A (EP): 9H-Thioxanthene 261-31-4 25mg
0025 S

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-393
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
Impurity B (EP): 9H-Thioxanthen-9-one
MM0125.02 492-22-8 100mg
(Thioxanthone) S

O
MM0125.02- Impurity B (EP): 9H-Thioxanthen-9-one
492-22-8 25mg
0025 (Thioxanthone) S

Metoclopramide Hydrochloride Monohydrate


O
MM0073.00-
Metoclopramide Hydrochloride Monohydrate 54143-57-6 250mg Cl
N
H
N
HCl H2 O

H 2N O
0250
Impurity A (EP): 4-(Acetylamino)-5-chloro-N-
O

[2-(diethylamino)ethyl]-2-methoxybenzamide O
Cl
N
N

MM0073.03 H
Related compound A (USP): 4-acetamido-5-chloro-N-[2-
5608-13-9 100mg N O
H

(diethylamino)ethyl]-2-methoxybenzamide
Impurity A (EP): 4-(Acetylamino)-5-chloro-N-
O
MM0073.03- [2-(diethylamino)ethyl]-2-methoxybenzamide O
Cl
N
N
H
Related compound A (USP): 4-acetamido-5-chloro-N-[2-
5608-13-9 25mg N O
0025 H

(diethylamino)ethyl]-2-methoxybenzamide
Impurity B (EP): Methyl 4-(Acetylamino)-5- O

chloro-2-methoxybenzoate O
Cl
O

Related compound B (USP): methyl 4-acetamido-5-chloro-


MM0073.04 4093-31-6 100mg
N O
H
2-methoxybenzoate
Impurity B (EP): Methyl 4-(Acetylamino)-5- O

MM0073.04- chloro-2-methoxybenzoate O
Cl
O

Related compound B (USP): methyl 4-acetamido-5-chloro-


4093-31-6 25mg
0025 N O
H
2-methoxybenzoate
O

Impurity C (EP): 4-Amino-5-chloro-2- Cl


OH
MM0073.02 7206-70-4 100mg
methoxybenzoic Acid
H 2N O

O
MM0073.02- Impurity C (EP): 4-Amino-5-chloro-2- Cl
OH
7206-70-4 25mg
0025 methoxybenzoic Acid
H 2N O

Impurity D (EP): Methyl 4-(Acetylamino)-2- O

methoxybenzoate O O
MM0073.05
Related compound D (USP): methyl 4-acetamido-2-
4093-29-2 100mg
N O
H
methoxybenzoate
Impurity D (EP): Methyl 4-(Acetylamino)-2- O

MM0073.05- methoxybenzoate O O

Related compound D (USP): methyl 4-acetamido-2-


4093-29-2 25mg
0025 N O
H
methoxybenzoate

MM0073.01 Impurity E (EP): N,N-Diethylethane-1,2-diamine 100-36-7 100mg N


H2 N

O
Impurity F (EP): 4-Amino-5-chloro-N-[2- Cl
N
N
MM0073.06 38339-95-6 100mg
(diethylamino)ethyl]-2-hydroxybenzamide H 2N OH
H

O
MM0073.06- Impurity F (EP): 4-Amino-5-chloro-N-[2- Cl
N
N
38339-95-6 25mg
0025 (diethylamino)ethyl]-2-hydroxybenzamide H 2N OH
H

Impurity G (EP): N'-(4-Amino-5-chloro-2-


O
methoxybenzoyl)-N,N-diethylethane- Cl
N
N
+

MM0073.07 171367-22-9 100mg


1,2-diamine N-Oxide H 2N O
H O

(Metoclopramide N-Oxide)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-394
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity H (EP): 4-(Acetylamino)-2- O OH


MM0073.08 50-86-2 100mg
hydroxybenzoic Acid N OH
H

MM0073.08- Impurity H (EP): 4-(Acetylamino)-2- O OH


50-86-2 25mg
0025 hydroxybenzoic Acid N OH
H

MM0073.09 Methyl 4-Amino-2-hydroxybenzoate 4136-97-4 100mg O

H2 N OH

O
MM0073.09-
Methyl 4-Amino-2-hydroxybenzoate 4136-97-4 25mg O
0025 H2 N OH

Methyl 4-(Acetylamino)-2- O O
MM0073.10
hydroxybenzoate
4093-28-1 100mg
N OH
H

MM0073.10- Methyl 4-(Acetylamino)-2- O O

hydroxybenzoate
4093-28-1 25mg
0025 N OH
H

Metolazone
O O O
S
MM1306.00 Metolazone 17560-51-9 250mg H 2N N

Cl N
H

Metomidate Hydrochloride
N

O
N
MM3173.00 Metomidate Hydrochloride 35944-74-2 100mg O HCl

Metopimazine

N N

MM1010.00 Metopimazine 14008-44-7 50mg S N H2

O
S
O O

NH

MM1010.03 2-Methylsulfonyl-10H-phenothiazine 23503-68-6 100mg S

S
O O

NH
MM1010.03- S
2-Methylsulfonyl-10H-phenothiazine 23503-68-6 25mg
0025
S
O O

Metoprolol Fumarate
OH O
H

MM3401.00 Metoprolol Fumarate 80274-67-5 100mg O


O N HO

2
O
OH

Metoprolol Succinate
OH O
MM0279.00- H

Metoprolol Succinate 98418-47-4 250mg O


O N HO

2
O
OH

0250

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-395
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity A (EP): (2RS)-1-(Ethylamino)-3-[4-(2-


methoxyethyl)phenoxy]propan-2-ol
OH
H
O N

Related compound A (USP): (+/-)1-(ethylamino)-3-[4-(2-


MM0027.04 109632-08-8 100mg O

methoxyethyl)phenoxy]-propan-2-ol
Impurity A (EP): (2RS)-1-(Ethylamino)-3-[4-(2-
methoxyethyl)phenoxy]propan-2-ol
OH
H
MM0027.04- O N

Related compound A (USP): (+/-)1-(ethylamino)-3-[4-(2-


109632-08-8 25mg O
0025
methoxyethyl)phenoxy]-propan-2-ol
Impurity A (EP) as Hydrochloride: (2RS)-1-(Ethylamino)-3-[4-
HCl OH
MM0027.30- H
(2-methoxyethyl)phenoxy]propan-2-ol Hydrochloride O N
n/a 25mg O
0025 Related compound A (USP): (+/-)1-(ethylamino)-3-[4-(2-
methoxyethyl)phenoxy]-propan-2-ol
OH

MM0027.01 Impurity B (EP): 4-(2-Methoxyethyl)phenol 56718-71-9 100mg


O

OH
MM0027.01-
Impurity B (EP): 4-(2-Methoxyethyl)phenol 56718-71-9 25mg
0025 O

Impurity C (EP) as Hydrochloride: 4-[(2RS)-2-


Hydroxy-3-[(1-methylethyl)amino]propoxy]- HCl OH
H

MM0027.24 benzaldehyde Hydrochloride 1956321-87-1 100mg O


O N

Related compound C (USP): (+/-)4-[2-Hydroxy-3-(1-


methylethyl)aminopropoxy]benzaldehyde
Impurity C (EP) as Hydrochloride: 4-[(2RS)-2-
MM0027.24- Hydroxy-3-[(1-methylethyl)amino]propoxy]- HCl OH
H

benzaldehyde Hydrochloride 1956321-87-1 25mg O


O N

0025 Related compound C (USP): (+/-)4-[2-Hydroxy-3-(1-


methylethyl)aminopropoxy]benzaldehyde
Impurity D (EP): (2RS)-3-[4-(2- OH
O OH
MM0027.06 Methoxyethyl)phenoxy]propane-1,2- 62572-90-1 100mg
O
diol

MM0027.06- Impurity D (EP): (2RS)-3-[4-(2- OH


O OH
Methoxyethyl)phenoxy]propane-1,2- 62572-90-1 25mg
O
0025 diol
Impurity E (EP): (2RS)-1-[2-(2-Methoxyethyl)- OH
H
O N
MM0027.07 phenoxy]-3-[(1-methylethyl)amino]propan- 163685-38-9 100mg
2-ol O

Impurity E (EP): (2RS)-1-[2-(2-Methoxyethyl)- OH


H
MM0027.07- O N
phenoxy]-3-[(1-methylethyl)amino]propan- 163685-38-9 25mg
0025 2-ol O

OH
Impurity F (EP): (2RS)-1-[(1-Methylethyl)amino]- O
H
N
MM0027.08 7695-63-8 100mg
3-phenoxypropan-2-ol
OH
MM0027.08- Impurity F (EP): (2RS)-1-[(1-Methylethyl)amino]- O
H
N
7695-63-8 25mg
0025 3-phenoxypropan-2-ol
OH

MM0027.09 Impurity G (EP): 2-(4-Hydroxyphenyl)ethanol 501-94-0 100mg


HO

OH
MM0027.09-
Impurity G (EP): 2-(4-Hydroxyphenyl)ethanol 501-94-0 25mg
0025 HO

Impurity H (EP): (2RS)-1-[4-(2-Hydroxyethyl)- OH


H
O N
MM0027.10 phenoxy]-3-[(1-methylethyl)amino]propan- 62572-94-5 100mg HO

2-ol

MM0027.10- Impurity H (EP): (2RS)-1-[4-(2-Hydroxyethyl)- OH


H
O N

phenoxy]-3-[(1-methylethyl)amino]propan- 62572-94-5 25mg HO


0025 2-ol
OH
(2RS)-1-(4-Ethenylphenoxy)-3- O
H
N

[(1-methylethyl)amino]propan-2-ol
MM0027.11 933468-54-3 100mg

OH
MM0027.11- (2RS)-1-(4-Ethenylphenoxy)-3- O
H
N

[(1-methylethyl)amino]propan-2-ol
933468-54-3 25mg
0025

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-396
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity J (EP): 1-[2-Hydroxy-3-[(1- OH OH


H
O O N

MM0027.12 methylethyl)amino]propoxy]-3-[4-(2- 163685-37-8 50mg O

methoxyethyl)phenoxy]propan-2-ol
(2RS)-1-[4-[(EZ)-2-Methoxyethenyl]- OH
H
O N
MM0027.13 phenoxy]-3-[(1methylethyl)amino]propan- 82961-02-2 100mg O

2-ol

MM0027.13- (2RS)-1-[4-[(EZ)-2-Methoxyethenyl]- OH
H
O N
phenoxy]-3-[(1methylethyl)amino]propan- 82961-02-2 25mg O

0025 2-ol
Impurity M (EP) as Dihydrochloride: 1,3-Bis[(1- H
N
OH
H
N
MM0027.28 73313-36-7 100mg HCl
methylethyl)amino]propan-2-ol Dihydrochloride 2

MM0027.28- Impurity M (EP) as Dihydrochloride: 1,3-Bis[(1- H


N
OH
H
N
73313-36-7 25mg HCl
0025 methylethyl)amino]propan-2-ol Dihydrochloride 2

OH
Impurity N (EP): (2RS)-3-[(1-Methylethyl)amino]- HO
H
N
MM0027.16 6452-57-9 100mg
propane-1,2-diol

Impurity O (EP): 1,1'-[(1-Methylethyl)imino]bis-


[3-[4-(2-methoxyethyl)phenoxy]propan- OH OH

MM0027.03 2-ol] 154784-36-8 100mg O


O N O

Related compound D (USP): (+/-)N,N-bis-[2-hydroxy-3-[4-(2-


methoxyethyl)phenoxy]propyl](1-methylethyl)amine
Impurity O (EP) as Hydrochloride: 1,1'-[(1-Methylethyl)imino]
OH OH
MM0027.29- bis[3-[4-(2-methoxyethyl)phenoxy]propan-2-ol] Hydrochloride O N O

1486464-40-7 25mg O
HCl
O

0025 Related compound D (USP): (+/-)N,N-bis-[2-hydroxy-3-[4-(2-


methoxyethyl)phenoxy]propyl](1-methylethyl)amine

Metoprolol Tartrate
OH
H
O N

MM0027.00 Metoprolol Tartrate 56392-17-7 500mg O


OH O
2

HO
OH
O OH

OH O
MM0279.00- H

Metoprolol Succinate
O N HO
OH
98418-47-4 250mg O
2
O

0250
Impurity A (EP): (2RS)-1-(Ethylamino)-3-[4-(2-
methoxyethyl)phenoxy]propan-2-ol
OH
H
O N

Related compound A (USP): (+/-)1-(ethylamino)-3-[4-(2-


MM0027.04 109632-08-8 100mg O

methoxyethyl)phenoxy]-propan-2-ol
Impurity A (EP): (2RS)-1-(Ethylamino)-3-[4-(2-
methoxyethyl)phenoxy]propan-2-ol
OH
H
MM0027.04- O N

Related compound A (USP): (+/-)1-(ethylamino)-3-[4-(2-


109632-08-8 25mg O
0025
methoxyethyl)phenoxy]-propan-2-ol
Impurity A (EP) as Hydrochloride: (2RS)-1-(Ethyl-amino)-3-
HCl OH
MM0027.30- H
[4-(2-methoxyethyl)phenoxy]propan-2-ol Hydrochloride O N
n/a 25mg O
0025 Related compound A (USP): (+/-)1-(ethylamino)-3-[4-(2-
methoxyethyl)phenoxy]-propan-2-ol
OH

MM0027.01 Impurity B (EP): 4-(2-Methoxyethyl)phenol 56718-71-9 100mg


O

OH
MM0027.01-
Impurity B (EP): 4-(2-Methoxyethyl)phenol 56718-71-9 25mg
0025 O

Impurity C (EP) as Hydrochloride: 4-[(2RS)-2-


Hydroxy-3-[(1-methylethyl)amino]propoxy]- HCl OH
H

MM0027.24 benzaldehyde Hydrochloride 1956321-87-1 100mg O


O N

Related compound C (USP): (+/-)4-[2-Hydroxy-3-(1-


methylethyl)aminopropoxy]benzaldehyde
Impurity C (EP) as Hydrochloride: 4-[(2RS)-2-
MM0027.24- Hydroxy-3-[(1-methylethyl)amino]propoxy]- HCl OH
H

benzaldehyde Hydrochloride 1956321-87-1 25mg O


O N

0025 Related compound C (USP): (+/-)4-[2-Hydroxy-3-(1-


methylethyl)aminopropoxy]benzaldehyde

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-397
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
Impurity D (EP): (2RS)-3-[4-(2-Methoxyethyl)- O OH
MM0027.06 62572-90-1 100mg
phenoxy]propane-1,2-diol O

OH
MM0027.06- Impurity D (EP): (2RS)-3-[4-(2-Methoxyethyl)- O OH
62572-90-1 25mg
0025 phenoxy]propane-1,2-diol O

Impurity E (EP): (2RS)-1-[2-(2-Methoxyethyl)- OH


H
O N
MM0027.07 phenoxy]-3-[(1-methylethyl)amino]propan- 163685-38-9 100mg
2-ol O

Impurity E (EP): (2RS)-1-[2-(2-Methoxyethyl)- OH


H
MM0027.07- O N
phenoxy]-3-[(1-methylethyl)amino]propan- 163685-38-9 25mg
0025 2-ol O

OH
Impurity F (EP): (2RS)-1-[(1-Methylethyl)amino]- O
H
N
MM0027.08 7695-63-8 100mg
3-phenoxypropan-2-ol
OH
MM0027.08- Impurity F (EP): (2RS)-1-[(1-Methylethyl)amino]- O
H
N
7695-63-8 25mg
0025 3-phenoxypropan-2-ol
OH

MM0027.09 Impurity G (EP): 2-(4-Hydroxyphenyl)ethanol 501-94-0 100mg


HO

OH
MM0027.09-
Impurity G (EP): 2-(4-Hydroxyphenyl)ethanol 501-94-0 25mg
0025 HO

Impurity H (EP): (2RS)-1-[4-(2-Hydroxyethyl)- OH


H
O N
MM0027.10 phenoxy]-3-[(1-methylethyl)amino]propan- 62572-94-5 100mg HO

2-ol

MM0027.10- Impurity H (EP): (2RS)-1-[4-(2-Hydroxyethyl)- OH


H
O N

phenoxy]-3-[(1-methylethyl)amino]propan- 62572-94-5 25mg HO


0025 2-ol
OH
(2RS)-1-(4-Ethenylphenoxy)-3- O
H
N
MM0027.11
[(1-methylethyl)amino]propan-2-ol
933468-54-3 100mg

OH
MM0027.11- (2RS)-1-(4-Ethenylphenoxy)-3- O
H
N
933468-54-3 25mg
0025 [(1-methylethyl)amino]propan-2-ol

Impurity J (EP): 1-[2-Hydroxy-3-[(1- OH OH


H
O O N

MM0027.12 methylethyl)amino]propoxy]-3-[4-(2- 163685-37-8 50mg O

methoxyethyl)phenoxy]propan-2-ol
(2RS)-1-[4-[(EZ)-2-Methoxyethenyl]- OH
H
O N
MM0027.13 phenoxy]-3-[(1methylethyl)amino]propan- 82961-02-2 100mg O

2-ol

MM0027.13- (2RS)-1-[4-[(EZ)-2-Methoxyethenyl]- OH
H
O N
phenoxy]-3-[(1methylethyl)amino]propan- 82961-02-2 25mg O

0025 2-ol
Impurity M (EP) as Dihydrochloride: 1,3-Bis[(1- H
N
OH
H
N
MM0027.28 73313-36-7 100mg HCl
methylethyl)amino]propan-2-ol Dihydrochloride 2

MM0027.28- Impurity M (EP) as Dihydrochloride: 1,3-Bis[(1- H


N
OH
H
N
73313-36-7 25mg HCl
0025 methylethyl)amino]propan-2-ol Dihydrochloride 2

OH
Impurity N (EP): (2RS)-3-[(1-Methylethyl)amino]- HO
H
N
MM0027.16 6452-57-9 100mg
propane-1,2-diol

Impurity O (EP): 1,1'-[(1-Methylethyl)imino]bis-


[3-[4-(2-methoxyethyl)phenoxy]propan- OH OH

MM0027.03 2-ol] 154784-36-8 100mg O


O N O

Related compound D (USP): (+/-)N,N-bis-[2-hydroxy-3-[4-(2-


methoxyethyl)phenoxy]propyl](1-methylethyl)amine
Impurity O (EP) as Hydrochloride: 1,1'-[(1-Methylethyl)imino]
OH OH
MM0027.29- bis[3-[4-(2-methoxyethyl)phenoxy]propan-2-ol] Hydrochloride O N O

1486464-40-7 25mg O
HCl
O

0025 Related compound D (USP): (+/-)N,N-bis-[2-hydroxy-3-[4-(2-


methoxyethyl)phenoxy]propyl](1-methylethyl)amine
O
1-[4-(2-Methoxyethyl)phenoxy]-2,3-epoxy- O

MM0027.02
propane
56718-70-8 100mg
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-398
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

1-Chloro-3-[4-(2-methoxyethyl)-
OH
phenoxy]propan-2-ol O Cl

Related compound B (USP): (+/-)1-Chloro-2-hydroxy-3-[4-


MM0027.17 56718-76-4 100mg
O

(2-methoxyethyl)phenoxy]-propane
OH
4,4'-(2-Hydroxy-1,3-propandiyldioxy)-bis[(2-methoxyethyl) O O

MM0027.18 230975-30-1 100mg O O

benzene]
OH
MM0027.22 3-Chloropropane-1,2-diol 96-24-2 100mg Cl OH

OH
MM0027.25-
2-Methoxyethylphenol 330976-39-1 100mg
0100 O

1-[2-(2-Methoxyethyl)phenyoxy]-2,3- O O

epoxypropane
MM0027.26 89507-60-8 50mg
O

OH
MM0027.27- 4-[2-[2-Hydroxy-3-(isopropylamino)-
2732276-87-6 25mg N O

0025 propoxy]ethyl]phenol H
OH

OH
O O

2,2'-(2-Hydroxy-1,3-propandiyldioxy)-bis[(2-methoxyethyl)
MM0027.31 n/a 50mg
benzene] (1,3-Bis[2-(2-methoxyethyl)phenoxy]propan-2-ol) O O

OH
H
MM0027.32- O N
1-[4-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]-2- HCl
68416-39-7 25mg O
0025 methoxyethanone Hydrochloride O

MM0027.33 (2-Methoxyethyl)benzene 3558-60-9 100mg


O

OH
MM0027.34- N-Desisopropylmetoprolol (1-Amino-3-[4-(2-methoxyethyl) O NH2
74027-60-4 25mg
0025 O
phenoxy]-2-propanol)
O
O
MM0027.35 1-[4-(2-Methoxyethyl)phenoxy]propan-2-one 1155083-53-6 100mg
O

Metrifonate
Cl Cl O
MM3417.01- Methyl (RS)-(2,2,2-Trichloro-1-hydroxyethyl)phosphonate P OH
684-31-1 25mg Cl
0025 Acid (Desmethylmetrifonate) O
OH

Metronidazole
O
O N+
MM0012.00- OH
Metronidazole 443-48-1 250mg N
0250
N

O
+ NH
MM0012.02 Impurity A (EP): 2-Methyl-4-nitroimidazole 696-23-1 100mg N
O N

O
MM0012.02- + NH
Impurity A (EP): 2-Methyl-4-nitroimidazole 696-23-1 25mg N
0025 O N

O
+ NH
MM0012.05 Impurity B (EP): 4-Nitroimidazole 3034-38-6 100mg N
O N

O
MM0012.05- + NH
Impurity B (EP): 4-Nitroimidazole 3034-38-6 25mg N
0025 O N

OH
Impurity C (EP): 2-(4-Nitro-1H-imidazol-1-yl)- O
N
+ N
MM0012.06 5006-69-9 100mg
ethanol O N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-399
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
MM0012.06- Impurity C (EP): 2-(4-Nitro-1H-imidazol-1-yl)- O
N
+ N
5006-69-9 25mg
0025 ethanol O N

O
O N+
Impurity D (EP): 2-(5-Nitro-1H-imidazol-1-yl)- OH
MM0012.07 5006-68-8 100mg N
ethanol
N

O
O N+
MM0012.07- Impurity D (EP): 2-(5-Nitro-1H-imidazol-1-yl)- OH
5006-68-8 25mg N
0025 ethanol
N

OH
Impurity E (EP): 2-(2-Methyl-4-nitro-1H- O
N
+ N
MM0012.01 705-19-1 100mg
imidazol-1-yl)ethanol O N

OH
MM0012.01- Impurity E (EP): 2-(2-Methyl-4-nitro-1H- O
N
+ N
705-19-1 25mg
0025 imidazol-1-yl)ethanol O N

O
O +

Impurity F (EP): 2-[2-(2-Methyl-5-nitro-1H- N


O
MM0012.08 16156-94-8 100mg N OH
imidazol-1-yl)ethoxy]ethanol N

O
O +
MM0012.08- Impurity F (EP): 2-[2-(2-Methyl-5-nitro-1H- N
O
16156-94-8 25mg N OH
0025 imidazol-1-yl)ethoxy]ethanol N

O
O N+
Impurity G (EP): 2-(2-Methyl-5-nitro-1H- OH
MM0012.09 1010-93-1 100mg N
imidazol-1-yl)acetic Acid O
N

O
O N+
MM0012.09- Impurity G (EP): 2-(2-Methyl-5-nitro-1H- OH
1010-93-1 25mg N
0025 imidazol-1-yl)acetic Acid O
N

O
O N+
1-(2-Hydroxyethyl)-2-hydroxymethyl-5-nitro- OH
N
imidazole (Hydroxymetronidazole)
MM0012.04 4812-40-2 100mg
N OH

O
O N+
MM0012.04- 1-(2-Hydroxyethyl)-2-hydroxymethyl-5-nitro- OH
N
imidazole (Hydroxymetronidazole)
4812-40-2 25mg
0025
N OH

O
O N+

N
MM0012.10- N
2-[2-(2-Methyl-4-nitro-1H-imidazol-1-yl)ethoxy]ethanol 19765-12-9 25mg
0025
O

HO

O
N O N
+

MM0012.11- 2-(2-Methyl-5-nitro-1H-imidazol-1-yl)ethyl Acetate (O- O


e 13182-82-6 25mg N
0025 Acetylmetronidazole) O
w N

Metronidazole Benzoate
O
O +
N
MM0278.00-
Metronidazole Benzoate 13182-89-3 250mg N
O

0250 O
N

O
O N+
MM0012.00- Impurity A (EP):2-(2-Methyl-5-nitro-1H-imidazol-1-yl)ethanol OH
443-48-1 250mg N
0250 (Metronidazole)
N

O
Impurity B (EP): 2-Methyl-4-nitroimidazole (2-Methyl-5- + NH
MM0012.02 696-23-1 100mg N
nitroimidazole) O N

O
MM0012.02- Impurity B (EP): 2-Methyl-4-nitroimidazole (2-Methyl-5- + NH
696-23-1 25mg N
0025 nitroimidazole) O N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-400
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
MM0278.01-
Impurity C (EP): Benzenecarboxylic Acid (Benzoic Acid) 65-85-0 250mg OH
0250

2-(2-Methyl-4-nitro-1H-imidazol-1-yl)- O
+ N
O

ethyl Benzoate
MM0278.04 87009-72-1 100mg N
O
O N

MM0278.04- 2-(2-Methyl-4-nitro-1H-imidazol-1-yl)- O
+ N
O

ethyl Benzoate
87009-72-1 25mg N
O
0025 O N

Metyrapone
O
N
MM1694.00 Metyrapone 54-36-4 100mg N

Mevastatin
O

MM0377.00 Mevastatin 73573-88-3 100mg H


OH
O O

O
+
Na
OH O
MM0377.01-
Mevastatin Acid Sodium Salt 99782-89-5 25mg H
O O
OH

0025

Mexiletine Hydrochloride
NH2
MM0146.00- O
HCl
Mexiletine Hydrochloride 5370-01-4 250mg
0250

OH
MM0146.01 Impurity A (EP): 2,6-Dimethylphenol 576-26-1 100mg

MM0146.01- OH
Impurity A (EP): 2,6-Dimethylphenol 576-26-1 25mg
0025

O
Impurity B (EP): 1-(2,6-Dimethylphenoxy)propan- O
MM0146.02 53012-41-2 100mg
2-one

MM0146.06- Impurity D (EP) as Hydrochloride: (2RS)-2-(2,6-Di- O


NH2
HCl
n/a 25mg
0025 methylphenoxy)propan-1-amine Hydrochloride

Mianserin Hydrochloride
N
N

MM0147.00 Mianserin Hydrochloride 21535-47-7 100mg HCl

N
N
Impurity A (EP): [2-[(2RS)-4-Methyl-2-phenyl-
MM0147.01 57321-32-1 100mg
piperazin-1-yl]phenyl]methanol
OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-401
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N
N
MM0147.01- Impurity A (EP): [2-[(2RS)-4-Methyl-2-phenyl-
57321-32-1 25mg
0025 piperazin-1-yl]phenyl]methanol
OH

NH2

MM0147.04 Impurity C (EP): (2-Aminophenyl)methanol 5344-90-1 100mg OH

NH2
MM0147.04-
Impurity C (EP): (2-Aminophenyl)methanol 5344-90-1 25mg OH
0025

Impurity E (EP) as Hydrochloride: (14bRS)- HN


N
1,2,3,4,10,14b-Hexahydrodibenzo[c,f]pyrazino[1,2- HCl
MM0147.05 76134-77-5 50mg
a]azepine Hydrochloride (Desmethylmianserin
Hydrochloride)
O
+
N
N
MM0147.06 Mianserin N-Oxide 62510-46-7 100mg

Miconazole Nitrate
Cl

O
MM0281.00- Cl
Miconazole Nitrate 22832-87-7 250mg O
HO N
+

O
0250 N
Cl Cl
N

Cl

Cl
MM0074.00 Miconazole 22916-47-8 250mg
O
N
Cl Cl
N

Cl
Impurity A (EP): (1RS)-1-(2,4-Dichlorophenyl)-
MM0281.01 24155-42-8 100mg N
2-(1H-imidazol-1-yl)ethanol Cl OH
N

Cl
MM0281.01- Impurity A (EP): (1RS)-1-(2,4-Dichlorophenyl)-
24155-42-8 25mg N
0025 2-(1H-imidazol-1-yl)ethanol Cl OH
N

Cl

Impurity B (EP) as Nitrate: 1-[(2RS)-2-[(4-


MM0524.00- Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)- Cl
HO N
O
+

24169-02-6 250mg
0250 ethyl]-1H-imidazole Nitrate (Econazole O
N
O

Cl
Nitrate) N

Impurity C (EP) as Nitrate: (2RS)-2-[(2,4- Cl

Dichlorobenzyl)oxy]-2-(2,4-dichloro-
O
MM0281.03 phenyl)ethanamine Nitrate n/a 100mg Cl
HO N
+

O
O
Related compound C (USP): 2-[(2,4-Dichlorobenzyl)oxy]-2- Cl Cl
N H2

(2,4-dichlorophenyl)ethan-1-amine
Impurity C (EP) as Nitrate: (2RS)-2-[(2,4- Cl

MM0281.03- Dichlorobenzyl)oxy]-2-(2,4-dichloro-
O
phenyl)ethanamine Nitrate n/a 25mg Cl
HO N
+

O
O
0025 Related compound C (USP): 2-[(2,4-Dichlorobenzyl)oxy]-2- Cl Cl
N H2

(2,4-dichlorophenyl)ethan-1-amine
Cl

Impurity D (EP) as Nitrate: 1-[(2RS)-2-[(2,6-


MM0541.00- Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)- Cl Cl
HO N
O
+
24168-96-5 250mg
0250 ethyl]-1H-imidazole Nitrate (Isoconazole O
N
O

Nitrate) Cl
N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-402
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity F (EP) as Nitrate: 1-[(2RS)-2-[(3,4- Cl

Dichlorobenzyl)oxy]-2-(2,4-dichloro- O
Cl
phenyl)ethyl]-1H-imidazole Nitrate
+
HO N
MM0281.06 27220-35-5 100mg O O

Related compound F (USP): 1-2-[(3,4-dichlorobenzyl)oxy]-2- Cl


N

Cl N
(2,4-dichlorophenyl)ethyl-1H-imidazole
Impurity F (EP) as Nitrate: 1-[(2RS)-2-[(3,4- Cl

MM0281.06- Dichlorobenzyl)oxy]-2-(2,4-dichloro- O
Cl
phenyl)ethyl]-1H-imidazole Nitrate
+
HO N
27220-35-5 25mg O O
0025 Related compound F (USP): 1-2-[(3,4-dichlorobenzyl)oxy]-2- Cl
N

Cl N
(2,4-dichlorophenyl)ethyl-1H-imidazole
Cl

Impurity G (EP) as Nitrate: 1-[(2RS)-2-[(2,5- O


Cl +

MM0281.07 Dichlorobenzyl)oxy]-2-(2,4-dichloro- 909277-72-1 100mg Cl


O
HO N
O

phenyl)ethyl]-1H-imidazole Nitrate Cl
N

Cl

MM0281.07- Impurity G (EP) as Nitrate: 1-[(2RS)-2-[(2,5- O


Cl +

Dichlorobenzyl)oxy]-2-(2,4-dichloro- 909277-72-1 25mg Cl


O
HO N
O
0025 phenyl)ethyl]-1H-imidazole Nitrate Cl
N

Cl

Impurity H (EP) as Nitrate: 1-[(2RS)-2-Benzyl- O


Cl +
MM0281.08 oxy-2-(2,4-dichlorophenyl)ethyl]-1H- 203264-09-9 100mg O
HO N
O

imidazole Nitrate N

Cl

Impurity H (EP) as Nitrate: 1-[(2RS)-2-Benzyl- O


MM0281.08- Cl +
oxy-2-(2,4-dichlorophenyl)ethyl]-1H- 203264-09-9 25mg O
HO N
O
0025 imidazole Nitrate N

Impurity I (EP) as Nitrate: 1-[(2RS)-2-[(2- Cl

Chlorobenzyl)oxy]-2-(2,4-dichloro- Cl
O
+
MM0281.09 phenyl)ethyl]-1H-imidazole Nitrate 24169-00-4 100mg O
HO N
O

Related compound I (USP): 1-2-[(2-Chlorobenzyl)oxy]-2- Cl


N

(2,4-dichlorophenyl)ethyl-1H-imidazole N

Impurity I (EP) as Nitrate: 1-[(2RS)-2-[(2- Cl

MM0281.09- Chlorobenzyl)oxy]-2-(2,4-dichloro- Cl
O
+
phenyl)ethyl]-1H-imidazole Nitrate 24169-00-4 25mg O
HO N
O
0025 Related compound I (USP): 1-2-[(2-Chlorobenzyl)oxy]-2- Cl
N

(2,4-dichlorophenyl)ethyl-1H-imidazole N

Cl

Cl
MM0281.10 1-(2,4-Dichlorobenzoylmethyl)imidazole 46503-52-0 100mg
O
N

Cl

MM0281.10- Cl
1-(2,4-Dichlorobenzoylmethyl)imidazole 46503-52-0 25mg
0025
O
N

Cl

MM0281.11- N-[2-(2,4-Dichlorophenyl)-2-[(2,4-dichlorophenyl)- Cl

methoxy]ethyl]formamide
911805-54-4 25mg
0025 O
HN
Cl Cl
O

Cl

MM0281.16- iso-Miconazole (1-[1-(2,4-Dichlorophenyl)-2-[(2,4- O


178813-04-2 25mg Cl Cl
N Cl
0025 dichlorophenyl)methoxy]ethyl]-1H-imidazole) N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-403
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Midazolam
N

MM1106.00-
Midazolam 59467-70-8 CS 250mg Cl N
0250
F

Impurity A (EP): (6RS)-8-Chloro-6-(2-fluorophenyl)-1-methyl-


MM1106.05 59468-07-4 50mg Cl N
5,6-dihydro-4H-imidazo[1,5-a][1,4]benzodiazepine H
F

Impurity B (EP): (6RS)-8-Chloro-6-(2-fluorophenyl)-1-methyl-


MM1106.06 59469-74-8 50mg Cl N
6H-imidazo[1,5-a][1,4]benzodiazepine
F

N O

N OH
MM1106.11- Impurity C (EP): 8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-
59468-44-9 25mg Cl N
0025 imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic Acid F

H
N NH2

Impurity E (EP): [(2RS)-7-Chloro-5-(2-fluorophenyl)-2,3- Cl N


MM1106.07 59467-64-0 100mg
dihydro-1H-1,4-benzodiazepin-2-yl]methanamine F

H O
N

Impurity F (EP): 7-Chloro-5-(2-fluorophenyl)-1,3-


Cl N
MM0070.02 dihydro-2H-1,4-benzodiazepin-2-one 2886-65-9 100mg
(1-Des[(diethylamino)ethyl]flurazepam) F

H O
N

Impurity F (EP): 7-Chloro-5-(2-fluorophenyl)-1,3-


MM0070.02- Cl N
dihydro-2H-1,4-benzodiazepin-2-one 2886-65-9 25mg
0025 (1-Des[(diethylamino)ethyl]flurazepam) F

N
Impurity H (EP): 6-Chloro-4-(2-fluorophenyl)-2- Cl
MM1106.08 119401-13-7 100mg
methylquinazoline F

N
MM1106.08- Impurity H (EP): 6-Chloro-4-(2-fluorophenyl)-2- Cl
119401-13-7 25mg
0025 methylquinazoline F

Impurity I (EP): (3aRS)-8-Chloro-6-(2-fluorophenyl)-1-methyl-


MM1106.04 59467-69-5 100mg Cl N
3a,4-dihydro-3H-imidazo[1,5-a][1,4]benzodiazepine
F

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-404
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM1106.04- Impurity I (EP): (3aRS)-8-Chloro-6-(2-fluorophenyl)-1-methyl-


59467-69-5 25mg Cl N
0025 3a,4-dihydro-3H-imidazo[1,5-a][1,4]benzodiazepine
F

Impurity J (EP): 8-Chloro-6-(2-fluorophenyl)-1-methyl-


MM1106.09 59469-08-8 100mg Cl N
3a,4,5,6-tetrahydro-3H-imidazo[1,5-a][1,4]benzodiazepine H
F

MM1106.09- Impurity J (EP): 8-Chloro-6-(2-fluorophenyl)-1-methyl-


59469-08-8 25mg Cl N
0025 3a,4,5,6-tetrahydro-3H-imidazo[1,5-a][1,4]benzodiazepine H
F

MM1106.13- 1-[4-Chloro-2-(2-fluorobenzoyl)phenyl]-2-methyl-1H- O
n/a 25mg Cl O
0025 imidazole-5-carboxaldehyde
F

N
O
MM1106.15- 3-[4-Chloro-2-(2-fluorobenzoyl)phenyl]-2-methyl-3H-
151921-06-1 25mg Cl O OH
0025 imidazole-4-carboxylic Acid
F

Midazolam Hydrochloride
N

MM3605.00 Midazolam Hydrochloride 59467-96-8 CS 250mg Cl N HCl

Midazolam Maleate
N

N O

OH
MM3404.00 Midazolam Maleate 59467-94-6 CS 250mg Cl N
OH

F O

O O OH
O
+
N
Midazolam Maleic Acid Addukt (3-Carboxy-2-[8-chloro-6-(2-
MM1106.14- N
fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4] 2531288-23-8 25mg
0025 Cl N
benzodiazepine-2-ium-2-yl]propanoate)
F

Midodrine Hydrochloride
2-Amino-1-(2,5-dimethoxyphenyl)ethanol OH
O NH2
MM3328.01 Related compound A (USP): 2-amino-1-(2,5- 3600-87-1 100mg
O
dimethoxyphenyl)ethanol
2-Amino-1-(2,5-dimethoxyphenyl)ethanol OH
MM3328.01- O NH2
Related compound A (USP): 2-amino-1-(2,5- 3600-87-1 25mg
0025 O
dimethoxyphenyl)ethanol

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-405
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Mifepristone
N
OH

MM1007.00 Mifepristone 84371-65-3 250mg H

H
O

O
+
N
OH

MM1007.02 Mifepristone N-Oxide 91934-98-4 100mg H

H
O

O
+
N
OH
MM1007.02-
Mifepristone N-Oxide 91934-98-4 25mg H
0025 H
O

H
MM1007.03 Estra-4,9-diene-3,17-dione 5173-46-6 100mg
H
O

MM1007.03- H
Estra-4,9-diene-3,17-dione 5173-46-6 25mg
0025 H
O

MM1274.02- Spiro[1,3-dioxolan-2,3'-estra-5'(10'),9'(11')-dien]-17'-one H
5571-36-8 25mg O H
0025 (Estra-5(10),9(11)-diene-3,17-dione 3-Ethylene
O

Milnacipran Hydrochloride
AND Enantiomer
O

MM0746.00 Milnacipran Hydrochloride 101152-94-7 250mg N HCl


H2 N

Milrinone
H
N O

MM1539.00 Milrinone 78415-72-2 250mg


N
N

H
6-Methyl-2-oxo-5-(4-pyridyl)-1H-pyridine-3-carboxamide N O

MM1539.01 Related compound A (USP): 1,6-Dihydro-2-methyl-6-oxo 80047-24-1 100mg NH2

N O
(3,4'-bipyridine)-5-carboxamide
H
6-Methyl-2-oxo-5-(4-pyridyl)-1H-pyridine-3-carboxamide N O
MM1539.01- NH2
Related compound A (USP): 1,6-Dihydro-2-methyl-6-oxo 80047-24-1 25mg
0025 N O
(3,4'-bipyridine)-5-carboxamide

Minocycline Hydrochloride Dihydrate


OH O OH O O
OH
N H2

MM1410.00 Minocycline Hydrochloride Dihydrate 128420-71-3 250mg H


H
OH
N N HCl H 2O
2

Minoxidil

N N N H2
MM0521.00 Minoxidil 38304-91-5 500mg N
+

O
NH2

Cl N NH2

Impurity A (EP): 6-Chloropyrimidine-2,4-diamine N


+
MM0521.01 35139-67-4 100mg
3-Oxide O
N H2

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-406
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Cl N NH2

MM0521.01- Impurity A (EP): 6-Chloropyrimidine-2,4-diamine N


+
35139-67-4 25mg
0025 3-Oxide O
N H2

Cl N NH2

MM0521.02 Impurity B (EP): 6-Chloropyrimidine-2,4-diamine 156-83-2 100mg N

N H2

Cl N NH2

MM0521.02-
Impurity B (EP): 6-Chloropyrimidine-2,4-diamine 156-83-2 25mg N
0025
N H2

Impurity E (EP): 6-(Piperidin-1-yl)pyrimidine-2,4-


N N N H2
diamine (Desoxyminoxidil)
MM0521.05
Related compound E (USP): 6-(Piperidin-1-yl)pyrimidine-
24867-26-3 100mg N

2,4-diamine NH2

Impurity E (EP): 6-(Piperidin-1-yl)pyrimidine-2,4-


N N N H2
MM0521.05- diamine (Desoxyminoxidil)
Related compound E (USP): 6-(Piperidin-1-yl)pyrimidine-
24867-26-3 25mg N
0025
2,4-diamine NH2

N N N H2
MM0521.06 5-Chloro-6-(piperidin-1-yl)pyrimidine-2,4-diamine 1784008-01-0 100mg N
Cl
NH2

N N N H2
MM0521.06-
5-Chloro-6-(piperidin-1-yl)pyrimidine-2,4-diamine 1784008-01-0 25mg N
0025 Cl
NH2

MM0521.07- N N
[2-Cyano-1-(piperidin-1-yl)ethylidene]cyanamide 56488-00-7 25mg N
0025
N

MM0521.08- N O
3-Oxo-3-(piperidin-1-yl)propanenitrile 15029-30-8 25mg
0025
N

Mirabegron
N H2

S N
MM3776.00-
Mirabegron 223673-61-8 250mg O
N
H
OH
0250 N
H

N H2

S N
MM3776.01-
2-Aminothiazole-4-acetic Acid 29676-71-9 25mg O
0025

OH

Mirtazapine

MM1005.00- N
Mirtazapine 85650-52-8 250mg N
0250
N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-407
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
Impurity A (EP): (14bRS)-2-Methyl-1,2,3,4,10- N
+

MM1005.02 14b-hexahydropyrazino[2,1-a]pyrido[2,3- 155172-12-6 100mg N


c][2]benzazepine 2-Oxide
N

O
MM1005.02- Impurity A (EP): (14bRS)-2-Methyl-1,2,3,4,10- N
+

14b-hexahydropyrazino[2,1-a]pyrido[2,3- 155172-12-6 25mg N


0025 c][2]benzazepine 2-Oxide
N

Impurity B (EP): [2-[(2RS)-4-Methyl-2-phenylpiperazin-1-yl] HO


N
MM1005.03 61337-89-1 100mg N
pyridin-3-yl]methanol
N

MM1005.03- Impurity B (EP): [2-[(2RS)-4-Methyl-2-phenylpiperazin-1-yl] HO


N
61337-89-1 25mg N
0025 pyridin-3-yl]methanol
N

Impurity D (EP): (14bRS)-1,2,3,4,10,14b-Hexahydropyrazino


MM1005.05- [2,1-a]pyrido[2,3-c][2]benzazepine (Desmethylmirtazapine) NH
61337-68-6 25mg N
0025 Related compound A (USP): 1,2,3,4,10,14b-
hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine N

Impurity D (EP) as Maleate: (14bRS)-1,2,3,4,10,14b-


O
Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benz-
MM1005.09- NH OH
azepine Maleate 135928-31-3 25mg N OH
0025 Related compound A (USP): 1,2,3,4,10,14b- N O

hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine

MM1005.01- Impurity E (EP): (2RS)-4-Methyl-1-(3-methyl- N


191546-94-8 25mg
0025 pyridin-2-yl)-2-phenylpiperazine N

Impurity F (EP): (14bRS)-2-Methyl-1,3,4,14b-


tetrahydropyrazino[2,1-a]pyrido-[2,3-c][2]benzazepin-10(2H)-
one (10-Oxomirtazapine) O
N
MM1005.06
Related compound D (USP): 2-Methyl-1,2,3,4-
191546-97-1 100mg N

tetrahydrobenzo[c]pyrazino[1,2-a]pyrido[3,2-f]azepin-10 N

(14bH)-one
Impurity F (EP): (14bRS)-2-Methyl-1,3,4,14b-
tetrahydropyrazino[2,1-a]pyrido-[2,3-c][2]benzazepin-10(2H)-
MM1005.06- one (10-Oxomirtazapine) O
N

Related compound D (USP): 2-Methyl-1,2,3,4-


191546-97-1 25mg N
0025
tetrahydrobenzo[c]pyrazino[1,2-a]pyrido[3,2-f]azepin-10 N

(14bH)-one

MM1005.07 1-Methyl-3-phenylpiperazine 5271-27-2 100mg N


HN

MM1005.07-
1-Methyl-3-phenylpiperazine 5271-27-2 25mg N
0025 HN

MM1005.10 2-(4-Methyl-2-phenylpiperazin-1-yl)pyridine-3-carboxylic Acid 61338-13-4 50mg N N

OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-408
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N Cl

MM1005.11 2-Chloropyridine-3-carbonitrile (2-Chloronicotinonitrile) 6602-54-6 100mg


N

N Cl
MM1005.11-
2-Chloropyridine-3-carbonitrile (2-Chloronicotinonitrile) 6602-54-6 25mg
0025
N

Mitomycin
O
H
H 2N O N
O

MM1308.00 Mitomycin 50-07-7 100mg O N

H 2N O

O
MM1308.01- NH2
Impurity A (EP): (E)-3-Phenylprop-2-enamide (Cinnamamide) 22031-64-7 25mg
0025

Mitoxantrone Hydrochloride
H
N
HO NH O OH

MM1085.00 Mitoxantrone Hydrochloride 70476-82-3 100mg HCl


2

HO NH O OH
N
H

Moclobemide
O O
MM0250.00-
Moclobemide 71320-77-9 250mg N
H
N

0250 Cl

O
OH
N
MM0250.02 4-Chloro-N-(2-hydroxyethyl)benzamide 7400-54-6 100mg H
Cl

O
MM0250.02- OH
N
4-Chloro-N-(2-hydroxyethyl)benzamide 7400-54-6 25mg H
0025 Cl

O O
MM0250.03- +
N
Moclobemide N-Oxide 64544-24-7 25mg N
H O
0025 Cl

O
MM0250.05- O
Methyl 4-Chlorobenzoate 1126-46-1 25mg
0025
Cl

O
MM0250.06- NH2
4-Chlorobenzamide 619-56-7 25mg
0025
Cl

Modafinil
O O
S
NH2
MM0540.00 Modafinil 68693-11-8 250mg

Impurity A (EP): [(RS)-(Diphenylmethyl)sulfinyl]acetic O O


S
Acid OH
MM0540.01 63547-24-0 50mg
Related compound A (USP): 2-[(diphenylmethyl)sulfinyl]
acetic acid
O O O
Impurity B (EP): 2-[(Diphenylmethyl)sulfonyl]acetamide S
MM0540.02- NH2
Related compound B (USP): 2-[(diphenylmethyl)sulfonyl] 118779-53-6 25mg
0025 acetamide

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-409
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O O
S
Impurity C (EP): Methyl [(RS)-(Diphenylmethyl)sulfinyl]- O
MM0540.03 63547-25-1 50mg
acetate

O
2-[(Diphenylmethyl)sulfenyl]acetamide S
NH2
MM0540.04 Related compound C (USP): 2-[(diphenylmethyl)sulfenyl] 68524-30-1 50mg
acetamide

Bis(diphenylmethyl) Ether O
Related compound D (USP): Bis(diphenylmethyl)ether
MM0599.14 574-42-5 50mg

Bis(diphenylmethyl)disulfide S
S
MM0540.06 Related compound E (USP): Bis(diphenylmethyl)disulfide 1726-02-9 50mg

Moexipril Hydrochloride
(S)-tert-Butyl 2-[(S)-2-[(S)-1-Ethoxy-1-oxo-4-phenylbutan-2-
ylamino]propanoyl]-6,7-dimethoxy-1,2,3,4-
O
tetrahydroisoquinoline-3-carboxylate Maleate (Moexipril tert- O O

MM3425.01- NH OH

O OH
Butyl Ester Maleate) 103733-40-0 25mg N O
O
0025 O
O
O
Related compound C (USP): (S)-tert-butyl 2-(S)-2-[(S)-1-
ethoxy-1-oxo-4-phenylbutan-2-ylamino]propanoyl-6,7-
dimethoxy-1,2,3,4-tetrahydroisoquinoline-3-carboxylate
(S)-2-[(S)-1-Ethoxy-1-oxo-4-phenylbutan-2-ylamino]propanoic
O
Acid ((2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino] H
N
OH
MM0010.05 propanoic Acid) 82717-96-2 100mg O O

Related compound F (USP): (S)-2-[(S)-1-ethoxy-1-oxo-4-


phenylbutan-2-ylamino]propanoic acid
(S)-2-[(S)-1-Ethoxy-1-oxo-4-phenylbutan-2-ylamino]propanoic
O
Acid ((2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino] H
N
MM0010.05- OH
propanoic Acid) 82717-96-2 25mg O O
0025
Related compound F (USP): (S)-2-[(S)-1-ethoxy-1-oxo-4-
phenylbutan-2-ylamino]propanoic acid

Molsidomine
O
O O
N
N
MM0267.00 Molsidomine 25717-80-0 250mg N
+

N
O

O
N
MM0267.03 Impurity B (EP): 4-Nitrosomorpholine 59-89-2 100mg N
O

O
MM0267.03- N
Impurity B (EP): 4-Nitrosomorpholine 59-89-2 25mg N
0025
O

N
N
Impurity C (EP): (2E)-(Morpholin-4-ylimino)- N
MM0267.01 26179-71-5 100mg
acetonitrile O

N
N
MM0267.01- Impurity C (EP): (2E)-(Morpholin-4-ylimino)- N
26179-71-5 25mg
0025 acetonitrile O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-410
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0267.07 Impurity D (EP): Morpholine-4-carbaldehyde 4394-85-8 100mg N


O

HN
MM0267.06 Impurity E (EP): Morpholine 110-91-8 100mg
O

H
N
MM0267.10- O O
1,3-Oxazolidin-2,4-dione 2346-26-1 25mg
0025
O

O
HO
MM0267.11 4-(Hydroxyacetyl)morpholine 51068-78-1 100mg N
O

O
MM0267.11- HO
4-(Hydroxyacetyl)morpholine 51068-78-1 25mg N
0025 O

Mometasone Furoate
Cl
O O

MM1272.00- HO O
Mometasone Furoate 83919-23-7 250mg H O

0250 Cl H
O

Cl

Impurity D (EP): 21-Chloro-9,11 -epoxy-16 -methyl- O O

MM1272.04- O

3,20-dioxo-9 -pregna-1,4-dien-17-yl Furan-2- 83881-09-8 25mg O O

0025 H H
carboxylate O

MM1272.05- Impurity E (EP): 9,21-Dichloro-16 -methyl-3,20- O


O O
Cl
O

O O
dioxopregna-1,4-diene-11 ,17-diyl Bis(furan- 1370190-33-2 25mg H O
0025
2-carboxylate) O
Cl H

Cl
O O

MM1272.06- Impurity F (EP): 9,21-Dichloro-11 -hydroxy-16 - HO O


H
methyl-3,6,20-trioxopregna-1,4-dien-17-yl 1305334-30-8 25mg Cl H
O

Furan-2-carboxylate
0025 O
O

Cl
O

MM1272.07- Impurity G (EP): 9,21-Dichloro-11 ,17-dihydroxy-16 - HO OH


105102-22-5 25mg H

0025 methylpregna-1,4-diene-3,20-dione (Mometasone) Cl H


O

OH
O O

MM1272.08- Impurity H (EP): 9-Chloro-11 ,21-dihydroxy-16alpha-methyl- HO O


H O
148596-90-1 25mg
0025 3,20-dioxopregna-1,4-dien-17-yl Furan-2-carboxylate Cl H
O

OH
O

MM1272.11- Impurity K (EP): 9-Chloro-11 ,17,21-trihydroxy-16 - HO OH


4647-20-5 25mg H

0025 methylpregna-1,4-diene-3,20-dione (Icometasone) Cl H


O

Impurity L (EP): 9,11 -Epoxy-17,21-dihydroxy-16 -methyl- O


OH
9 -pregna-1,4-diene-3,20-dione (9 ,11 -Epoxy-17,21- OH
O
MM0213.04 24916-90-3 100mg
dihydroxy-16 -methylpregna-1,4-diene-3,20-dione; H H
O
Dexamethasone 9,11-Epoxide)
Impurity L (EP): 9,11 -Epoxy-17,21-dihydroxy-16 -methyl- O
OH
MM0213.04- 9 -pregna-1,4-diene-3,20-dione (9 ,11 -Epoxy-17,21- OH
O
24916-90-3 25mg
0025 dihydroxy-16 -methylpregna-1,4-diene-3,20-dione; H H
O
Dexamethasone 9,11-Epoxide)
O

HO OH
MM1272.12- Impurity M (EP): 9-Chloro-11 ,17-dihydroxy-16 - H
57780-86-6 25mg
0025 methylpregna-1,4-diene-3,20-dione Cl H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-411
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O O

O S
Impurity N (EP): 9-Chloro-11 ,17-dihydroxy-16 -methyl-3,20- O
MM1272.13- HO OH
dioxopregna-1,4-dien-21-yl Methanesulfonate (Icometasone 352315-75-4 25mg H
0025 Cl H
21-Mesylate) O

O
Impurity O (EP): 9-Chloro-11 ,17-dihydroxy-16 -methyl-3,20- O
MM1272.14- HO OH
dioxopregna-1,4-dien-21-yl Acetate (Icometasone 21- 24916-91-4 25mg H
0025 Cl H
Acetate) O

Impurity P (EP): 9-Chloro-11 ,17-dihydroxy-16 -methyl-3,20- O


O
MM1272.15- O
HO OH
dioxopregna-1,4-dien-21-yl Furan-2-carboxylate n/a 25mg H
0025 Cl H
(Icometasone 21-Furoate) O

Cl
O

MM1272.16- Impurity Q (EP): 21-Chloro-9,11 -epoxy-17-hydroxy-16 - OH


83881-08-7 25mg O

0025 methyl-9 -pregna-1,4-diene-3,20-dione H H


O

O O

O S
Impurity R (EP): 9-Chloro-11 -hydroxy-16 -methyl-21- O O
MM1272.17- HO O
[(methylsulfonyl)oxy]-3,20-dioxopregna-1,4-dien-17-yl Furan- 1370190-08-1 25mg H O
0025 Cl H
2-carboxylate O

Cl
O O
Impurity S (EP): 9,21-Dichloro-11 -hydroxy-16 -methyl-3,20-
MM1272.18- HO O
H O
dioxopregna-1,4-dien-17-yl Furan-2-carboxylate (16-epi- 2231764-75-1 25mg
0025 Cl H

Mometasone Furoate) O

Cl
O O

HO O
MM1272.24- H O
6- -Hydroxy Mometasone Furoate 132160-74-8 25mg Cl H
0025 O
OH

Monoethyl Fumarate Calcium


O

MM3479.00 Monoethyl Fumarate Calcium 62008-22-4 250mg O

O
O Ca
2+

Monoethyl Fumarate Magnesium


O

MM3481.00 Monoethyl Fumarate Magnesium 83918-60-9 250mg O

O
O Mg
2+

Montelukast Sodium
O +
Na
Cl N S
O

MM0698.00 Montelukast Sodium 151767-02-1 100mg HO

O
Cl N S
OH

HO

MM0698.15 Montelukast Dicyclohexylamine 577953-88-9 100mg


H
N

O
Cl N S
OH

HO
MM0698.15-
Montelukast Dicyclohexylamine 577953-88-9 25mg
0025 H
N

Impurity B (EP): [1-[[[(1R)-1-[3-[(E)-2-(7-Chloroquinolin-2-yl) Cl N S


O

OH

MM0698.02 ethenyl]phenyl]-3-[2-(1-methylethenyl)phenyl]propyl]sulfanyl] 918972-54-0 100mg


methyl]cyclopropyl]acetic Acid

MM0698.02- Impurity B (EP): [1-[[[(1R)-1-[3-[(E)-2-(7-Chloroquinolin-2-yl) Cl N S


O

OH

ethenyl]phenyl]-3-[2-(1-methylethenyl)phenyl]propyl]sulfanyl] 918972-54-0 25mg


0025 methyl]cyclopropyl]acetic Acid
Impurity C (EP): [1-[[[1-[3-[(E)-2-(7-Chloroquinolin-2-yl) O O
Cl N S
OH
MM0698.10- HO
ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl] 2641214-96-0 25mg
0025
sulfinyl]methyl]cyclopropyl]acetic Acid
O
H
Cl N S
OH
MM0698.11- S
H
HO
Impurity D (EP): (R,R)-Montelukast Bissulfide 1187586-61-3 25mg
0025 O OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-412
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O
H
Cl N S
OH
MM0698.12- H

Impurity E (EP): (R,S)-Montelukast Bissulfide 1187586-58-8 25mg S


HO

0025 O OH

Cl

MM0698.13- Impurity G (EP): [1-[[[(1R)-1-[3-[(Z)-2-(7-Chloroquinolin-2-yl) N


O

ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl] 774538-96-4 25mg S


OH

0025 sulfanyl]methyl]cyclopropyl]acetic Acid HO

O
Cl N S
O

HO
MM0698.16 Montelukast Methyl Ester 855473-51-7 100mg
O
Cl N S
O

HO
MM0698.17 Montelukast Ethyl Ester 1044705-96-5 100mg

O
Cl N S
O
MM0698.18- HO
Montelukast Isopropyl Ester n/a 25mg
0025
Cl N OH
(1R)-1-[3-[(E)-2-(7-Chloro-2-quinolyl)vinyl]phenyl]-3-[2-(1-
HO
MM0698.21 150026-75-8 100mg
hydroxy-1-methylethyl)phenyl]propan-1-ol
Cl N OH
MM0698.21- (1R)-1-[3-[(E)-2-(7-Chloro-2-quinolyl)vinyl]phenyl]-3-[2-(1-
HO
150026-75-8 25mg
0025 hydroxy-1-methylethyl)phenyl]propan-1-ol
Cl N OH
MM0698.22- (1S)-1-[3-[(E)-2-(7-Chloro-2-quinolyl)ethenyl]phenyl]-3-[2-(1-
HO
287930-77-2 100mg
0100 hydroxy-1-methylethyl)phenyl]propan-1-ol
Cl N OH
MM0698.22- (1S)-1-[3-[(E)-2-(7-Chloro-2-quinolyl)ethenyl]phenyl]-3-[2-(1-
HO
287930-77-2 25mg
0025 hydroxy-1-methylethyl)phenyl]propan-1-ol

O
MM0698.23- 1-(Mercaptomethyl)cyclopropaneacetic Acid (2-[1-
162515-68-6 25mg HS
0025 (Sulfanylmethyl)cyclopropyl]acetic Acid) OH

MM0698.34- (E)-1-[3-[2-(7-Chloroquinolin-2-yl)ethenyl]phenyl]-2-propen-1- Cl N OH
149968-10-5 25mg
0025 ol
HO
MM0698.38- O
[1-[(Benzyloxy)methyl]cyclopropyl]methanol 177200-76-9 100mg
0100

Morinamide Hydrochloride
O

MM3142.00 Morinamide Hydrochloride 1473-73-0 50mg N


N
N
H
N
O
HCl

Moroxydine Hydrochloride
NH NH

MM1749.00 Moroxydine Hydrochloride 3160-91-6 250mg O


N N
H
N H2 HCl

Morphine Hydrochloride
N

MM0037.00 Morphine Hydrochloride Trihydrate 6055-06-7 CS 250mg H HCl H 2O


3

HO O OH

MM0037.09 Morphine Anhydrate 57-27-2 CS 100mg H

HO O OH

Impurity A (EP) as Phosphate Hemihydrate: H


HO
P
OH

OH
H2O
MM0442.00 41444-62-6 CS 100mg O

Codeine Phosphate Hemihydrate O O OH


2
2

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-413
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity B (EP): 7,7',8,8'-Tetradehydro-4,5 :4',5' -


diepoxy-17,17'-dimethyl-2,2'-bimorphinanyl- HO O OH
H
N

MM0037.01 3,3',6 ,6' -tetrol (Pseudomorphine; 125-24-6 100mg H


HO O OH

2,2'-Bismorphine) N

Related compound B (USP): Pseudomorphine


Impurity B (EP): 7,7',8,8'-Tetradehydro-4,5 :4',5' -
MM0037.01- diepoxy-17,17'-dimethyl-2,2'-bimorphinanyl- HO O OH
H
N

3,3',6 ,6' -tetrol (Pseudomorphine; 125-24-6 25mg H


HO O OH

2,2'-Bismorphine)
0025 N

Related compound B (USP): Pseudomorphine


N

Impurity C (EP): 6,7,8,14-Tetradehydro-4,5 -epoxy-6-


MM0037.13 467-04-9 CS 100mg
methoxy-17-methylmorphinan-3-ol (Oripavine)
HO O O

MM0037.13- Impurity C (EP): 6,7,8,14-Tetradehydro-4,5 -epoxy-6-


467-04-9 CS 25mg
0025 methoxy-17-methylmorphinan-3-ol (Oripavine)
HO O O

HO N

MM0037.27- Impurity D (EP): 7,8-Didehydro-4,5 -epoxy-17- H


131563-73-0 25mg
0025 methylmorphinan-3,6 ,10 -triol (10S-Hydroxymorphine)
HO O OH

MM0037.23- Impurity E (EP): 7,8-Didehydro-4,5 -epoxy-3-hydroxy-17- H


467-02-7 25mg
0025 methylmorphinan-6-one (Morphinone)
HO O O

Impurity F (EP): (17S)-7,8-Didehydro-4,5 - O N


+

MM0037.03 epoxy-17-methylmorphinan-3,6 -diol 639-46-3 CS 100mg H


17-Oxide (Morphine N-Oxide)
Related compound A (USP): Morphine N-Oxide HO O OH

N
HO O O
H

MM0037.02 Dimethyl Pseudomorphine 121395-47-9 100mg H


O O OH
N

N
HO O O
MM0037.02- H

Dimethyl Pseudomorphine 121395-47-9 25mg H


O O OH
0025 N

H
N

MM0037.05- Normorphine (7,8-Didehydro-4,5 - H


466-97-7 CS 25mg
0025 epoxymorphinan-3,6 -diol)
HO O OH

H
MM0037.14 6-Acetylmorphine 2784-73-8 CS 100mg
O
HO O O

MM0037.14- H
6-Acetylmorphine 2784-73-8 CS 25mg
0025 O
HO O O

MM0037.15- O H

Morphine 3- -D-Glucuronide 20290-09-9 CS 25mg HO


O
0025 HO O O OH

HO OH

MM0037.17- H
Heroin (Diacetylmorphine) 561-27-3 CS 50mg
0050 O O
O O O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-414
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Heroin Hydrochloride Monohydrate H


HCl H2O

(Diacetylmorphine Hydrochloride Monohydrate)


MM0037.20 5893-91-4 CS 50mg O O
O O O

MM0037.24- H O O

3-Acetylmorphine Sulfamate 62319-25-9 CS 25mg O


H2 N
S
OH
0025 O O OH

Morphine Sulphate
N
O

MM0280.00 Morphine Hemisulphate Pentahemihydrate 6211-15-0 CS 250mg H HO S O H


O
H2O
5

HO O OH
2

Impurity A (EP) as Phosphate Hemihydrate: H


HO
P
OH

OH
H2O
MM0442.00 41444-62-6 CS 100mg O

Codeine Phosphate Hemihydrate O O OH


2
2

Impurity B (EP): 7,7',8,8'-Tetradehydro-4,5 :4',5' -


diepoxy-17,17'-dimethyl-2,2'-bimorphinanyl- HO O OH
H
N

MM0037.01 3,3',6 ,6' -tetrol (Pseudomorphine; 125-24-6 100mg H


HO O OH

2,2'-Bismorphine) N

Related compound B (USP): Pseudomorphine


Impurity B (EP): 7,7',8,8'-Tetradehydro-4,5 :4',5' -
MM0037.01- diepoxy-17,17'-dimethyl-2,2'-bimorphinanyl- HO O OH
H
N

3,3',6 ,6' -tetrol (Pseudomorphine; 125-24-6 25mg H


HO O OH

2,2'-Bismorphine)
0025 N

Related compound B (USP): Pseudomorphine


N

Impurity C (EP): 6,7,8,14-Tetradehydro-4,5 -epoxy-6-


MM0037.13 467-04-9 CS 100mg
methoxy-17-methylmorphinan-3-ol (Oripavine)
HO O O

MM0037.13- Impurity C (EP): 6,7,8,14-Tetradehydro-4,5 -epoxy-6-


467-04-9 CS 25mg
0025 methoxy-17-methylmorphinan-3-ol (Oripavine)
HO O O

HO N

MM0037.27- Impurity D (EP): 7,8-Didehydro-4,5 -epoxy-17- H


131563-73-0 25mg
0025 methylmorphinan-3,6 ,10 -triol (10S-Hydroxymorphine)
HO O OH

MM0037.23- Impurity E (EP): 7,8-Didehydro-4,5 -epoxy-3-hydroxy-17- H


467-02-7 25mg
0025 methylmorphinan-6-one (Morphinone)
HO O O

Impurity F (EP): (17S)-7,8-Didehydro-4,5 -epoxy- O N


+

MM0037.03 17-methylmorphinan-3,6 -diol 17-Oxide 639-46-3 CS 100mg H


(Morphine N-Oxide)
Related compound A (USP): Morphine N-Oxide HO O OH

Moxifloxacin Hydrochloride
H
O
N HCl
MM0885.00- H
H
N N
Moxifloxacin Hydrochloride 186826-86-8 250mg OH
0250 F
O O

Impurity A (EP): 1-Cyclopropyl-6,8-difluoro-7-[(4aS,7aS)-


octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4- H
F
MM0885.04- dihydroquinoline-3-carboxylic Acid 151213-15-9 25mg
N
HH N N

0025 Related compound A (USP): 1-cyclopropyl-6,8-difluoro-1,4- F


OH

dihydro-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4- O O

oxo-3-quinolinecarboxylic acid

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-415
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH

1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-hydroxy-4-oxo-3- F N
MM0885.01 154093-72-8 100mg
quinolinecarboxylic Acid OH
F
O O

OH

MM0885.01- 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-hydroxy-4-oxo-3- F N
154093-72-8 25mg
0025 quinolinecarboxylic Acid OH
F
O O

Impurity H (EP): Methyl 1-Cyclopropyl-6-fluoro-8-methoxy-7- H


O
MM0885.09- [(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo- N
HH N N
721970-35-0 25mg O
0025 1,4-dihydroquinoline-3-carboxylate (Moxifloxacin Methyl F
O O

Ester)
H
O
MM0885.10- N
HH N N
Moxifloxacin Ethyl Ester 1403836-23-6 25mg O
0025 F
O O

H
O
MM0885.11- N
HH N N
Moxifloxacin Isopropyl Ester 1585176-91-5 25mg O
0025 F
O O

1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-methoxy-4-oxo-3- F N
MM0885.13 112811-72-0 100mg OH
quinolinecarboxylic Acid F
O O

MM0885.13- 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-methoxy-4-oxo-3- F N
112811-72-0 25mg OH
0025 quinolinecarboxylic Acid F
O O

1-Cyclopropyl-6,7,8-trifluoro-1,4-dihydro-4-oxoquinoline-3- F N
MM0885.14 94695-52-0 100mg
carboxylic Acid OH
F
O O

MM0885.14- 1-Cyclopropyl-6,7,8-trifluoro-1,4-dihydro-4-oxoquinoline-3- F N
94695-52-0 25mg
0025 carboxylic Acid OH
F
O O

MM0885.15- (4aS,7aS)-Octahydro-1H-pyrrolo[3,4-b]pyridine ((1S,6S)-2,8- NH


151213-40-0 100mg
0100 Diazabicyclo[4.3.0]nonane)
N
H H

O
MM0885.16- 1-Cyclopropyl-6,7-difluoro-8-methoxy-4-oxo-1,4- F N
112811-71-9 25mg O
0025 dihydroquinoline-3-carboxylic Acid Ethyl Ester F
O O

MM0885.17- 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-4-oxoquinoline-3- F N
93107-30-3 25mg
0025 carboxylic Acid OH
F
O O

O
MM0885.19- 1-Cyclopropyl-8-ethoxy-6,7-difluoro-1,4-dihydro-4-oxo-3- F N
172602-83-4 25mg O
0025 quinolinecarboxylic Acid Ethyl Ester F
O O

O
MM0885.20- 7-Amino-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-4-oxo- H 2N N
172426-88-9 25mg OH
0025 3-quinolinecarboxylic Acid F
O O

H
O
MM0885.22- N
H N N
H HCl
(R,R)-Moxifloxacin Hydrochloride 1394029-14-1 25mg F
OH
0025 O O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-416
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Moxisylyte Hydrochloride
O
O N

MM1980.00 Moxisylyte Hydrochloride 964-52-3 100mg O


HCl

Moxonidine
N Cl
HN
MM1278.00- N
Moxonidine 75438-57-2 250mg N N
H
0250 O

N Cl
Impurity A (EP): 4,6-Dichloro-N-(imidazolidin-2- HN

MM1278.01 ylidene)-2-methylpyrimidin-5-amine 352457-35-3 100mg N


N N
H
(6-Chloromoxonidine) Cl

N Cl
MM1278.01- Impurity A (EP): 4,6-Dichloro-N-(imidazolidin-2- HN

ylidene)-2-methylpyrimidin-5-amine 352457-35-3 25mg N


N N
H
0025 (6-Chloromoxonidine) Cl

Impurity B (EP): N-(Imidazolidin-2-ylidene)-4,6- N O


HN
MM1278.02 dimethoxy-2-methylpyrimidin-5-amine 75439-01-9 100mg N
N N
(4-Methoxymoxonidine) O
H

MM1278.02- Impurity B (EP): N-(Imidazolidin-2-ylidene)-4,6- N O


HN
dimethoxy-2-methylpyrimidin-5-amine 75439-01-9 25mg N
N N
0025 (4-Methoxymoxonidine) O
H

N Cl
MM1278.07- N
4,6-Dichloro-2-methylpyrimidin-5-amine 39906-04-2 25mg NH2
0025
Cl

Mupirocin
O OH

MM1340.00 Mupirocin 12650-69-0 250mg O


OH
O

OH OH O

O O

O
2+
Ca H 2O
O 2
MM3467.00 Mupirocin Calcium Dihydrate 115074-43-6 250mg OH
O
OH OH O
2

Mupirocin Calcium
O O

Mupirocin Calcium Dihydrate


O
2+
Ca H 2O
O 2
MM3467.00 115074-43-6 250mg OH
O
OH OH O
2

O OH

MM1340.00 Mupirocin 12650-69-0 250mg O


OH
O
OH OH O

Mycophenolate Mofetil
O OH

MM1001.00- O

Mycophenolate Mofetil 128794-94-5 250mg O


O
O
N
O

0250
Impurity E (EP): Methyl (4E)-6-(4-Hydroxy-6-methoxy-7- O OH
O

MM1001.05 methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4- 31858-66-9 100mg O


O
O

enoate

MM1001.05- Impurity E (EP): Methyl (4E)-6-(4-Hydroxy-6-methoxy-7- O OH


O

methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4- 31858-66-9 25mg O


O
O
0025 enoate

MM1001.06- Impurity F (EP): (4E)-6-(4-Hydroxy-6-methoxy-7- O OH


OH

methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)- 24280-93-1 250mg O


O
O
0250 4-methylhex-4-enoic Acid (Mycophenolic Acid)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-417
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity G (EP): 2-(Morpholin-4-yl)ethyl (4E)-6-


OH

(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3-
O O
O +
N
O
MM1001.07 224052-51-1 100mg O O

dihydroisobenzofuran-5-yl)-4-methylhex-4- O

enoate N-Oxide
Impurity H (EP): 7-Hydroxy-5-methoxy-4-methyl-
6-[2-[(2RS)-2-methyl-5-oxotetrahydrofuran-2- O OH

MM1001.08- yl]ethyl]isobenzofuran-1(3H)-one O O
O
Related compound B (USP): (RS)-7-hydroxy-5-methoxy-4-
26675-76-3 25mg O
0025
methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-
isobenzofuranyl-1-one
O OH
O
O
MM1001.09 Ethyl Mycophenolate 32483-51-5 100mg O
O

O OH

MM1001.09- O
O
Ethyl Mycophenolate 32483-51-5 25mg O
O
0025
O OH
O
MM1001.10- O
Isopropyl Mycophenolate 40336-80-9 25mg O
O
0025
HO
MM1001.11- N
2-(4-Morpholinyl)ethanol 622-40-2 100mg O
0100

Mycophenolate Sodium
O OH
O

MM3657.00 Mycophenolate Sodium 37415-62-6 250mg O


O
O
+
Na

Impurity A (EP): 7-Hydroxy-5-methoxy-4-methyl-6-[2-[(2RS)-


OH

MM1001.08- 2-methyl-5-oxotetrahydrofuran-2-yl]ethyl]-2-benzofuran-1 O

(3H)-one (7-Hydroxy-5-methoxy-4-methyl-6-[2-[(2RS)-2- 26675-76-3 25mg O


O
O
O
0025 methyl-5-oxotetrahydrofuran-2-yl]ethyl]isobenzofuran-1(3H)-
one)
O OH

Methyl (4E)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3- O
O

MM1001.05 O
dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate
31858-66-9 100mg O

O OH

MM1001.05- Methyl (4E)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3- O


O

31858-66-9 25mg O
0025 dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate O

O OH
O
O
MM1001.09 Ethyl Mycophenolate 32483-51-5 100mg O
O

O OH

MM1001.09- O
O
Ethyl Mycophenolate 32483-51-5 25mg O
O
0025
O OH

MM1001.10- O
O
Isopropyl Mycophenolate 40336-80-9 25mg O
O
0025

Nabumetone
O

MM0153.00 Nabumetone 42924-53-8 500mg


O

Impurity A (EP): 3-(6-Methoxynaphthalen-2-


MM0153.02 343272-52-6 100mg
yl)-5-methylcyclohexanone
O

MM0153.02- Impurity A (EP): 3-(6-Methoxynaphthalen-2-


343272-52-6 25mg
0025 yl)-5-methylcyclohexanone
O

Impurity B (EP): (5RS)-5-(6-Methoxynaphthalen-


MM0153.03 343272-51-5 100mg
2-yl)-3-methylcyclohex-2-enone
O

MM0153.03- Impurity B (EP): (5RS)-5-(6-Methoxynaphthalen-


343272-51-5 25mg
0025 2-yl)-3-methylcyclohex-2-enone
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-418
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
Impurity C (EP): (2RS)-4-(6-Methoxynaphthalen-
MM0153.04 65726-24-1 100mg
2-yl)-butan-2-ol O

OH
MM0153.04- Impurity C (EP): (2RS)-4-(6-Methoxynaphthalen-
65726-24-1 25mg
0025 2-yl)-butan-2-ol O

O
Impurity D (EP): (E)-4-(6-Methoxynaphthalen-
MM0153.05 127053-22-9 100mg
2-yl)-but-3-en-2-one O

O
MM0153.05- Impurity D (EP): (E)-4-(6-Methoxynaphthalen-
127053-22-9 25mg
0025 2-yl)-but-3-en-2-one O

Impurity E (EP): 1,5-Bis(6-methoxynaphthalen- O

MM0153.06 343272-53-7 50mg


2-yl)pentan-3-one O O

Impurity F (EP): 6,6'-Dimethoxy-2,2'-


MM0153.07 29619-45-2 100mg
binaphthalenyl O

O
MM0153.07- Impurity F (EP): 6,6'-Dimethoxy-2,2'-
29619-45-2 25mg
0025 binaphthalenyl O

(6-Methoxy-2-naphthyl)acetic Acid OH

MM0152.01 ((6-Methoxynaphthalen-2-yl)acetic 23981-47-7 100mg O


O

Acid, -Demethylnaproxen)
(6-Methoxy-2-naphthyl)acetic Acid OH
MM0152.01-
((6-Methoxynaphthalen-2-yl)acetic 23981-47-7 25mg O
O
0025 Acid, -Demethylnaproxen)

Nadolol

MM0439.06- Impurity F (EP) as Hydrochloride: (2RS)-1-[(1,1- OH


H

Dimethylethyl)amino]-3-(naphthalen-1-yloxy)- 15230-34-9 25mg O N HCl

0025 propan-2-ol Hydrochloride

MM0439.07- Impurity G (EP) as Hydrochloride: (2RS)-1-[(1,1-Dimethyl- OH


H

ethyl)amino]-3-[(5,6,7,8-tetrahydronaphtalen-1-yl)oxy]- 15148-92-2 25mg O N HCl

0025 propan-2-ol Hydrochloride

Naepaine Hydrochloride
O
H

Naepaine Hydrochloride
N
O HCl
MM3146.00 614-42-6 100mg H 2N

Nafcillin Sodium
HO
O
O
HN
MM0392.02 Penilloic Acids of Nafcillin 940306-33-2 100mg H
N
S

HO
O
O
MM0392.02- HN
Penilloic Acids of Nafcillin 940306-33-2 25mg H
N
S
0025
O

O
OH
O
MM0026.04 6-Aminopenicillanic Acid 551-16-6 100mg N

H 2N S
H

O
OH
MM0026.04- O
6-Aminopenicillanic Acid 551-16-6 25mg N
0025 S
H 2N
H

O OH

O
MM0392.04 2-Ethoxynaphthoic Acid 2224-00-2 100mg

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-419
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O OH

MM0392.04- O
2-Ethoxynaphthoic Acid 2224-00-2 25mg
0025

Naftazone
O
MM1046.00- N
Naftazone 15687-37-3 250mg NH

0250 O NH2

O O
N N
MM1046.01- 3-Bis[(1-oxo-2-naphthylidene)amino]urea (Naftazone Impurity N N
H H
n/a 25mg O
0025 Blue)

Naftidrofuryl Hydrogen Oxalate


O
N O OH

MM0373.00 Naftidrofuryl Hydrogen Oxalate 3200-06-4 500mg O

O OH
O

Nalbuphine Hydrochloride

MM0341.00 Nalbuphine Hydrochloride 23277-43-2 250mg HO HCl

HO O OH

O
+
N

MM0341.02 Nalbuphine N-Oxide Hydrochloride n/a 100mg HO HCl

HO O OH

O
+
N
MM0341.02-
Nalbuphine N-Oxide Hydrochloride n/a 25mg HO HCl

0025
HO O OH

Nalidixic Acid

N N
MM3144.00 Nalidixic Acid 389-08-2 250mg OH

O O

N N
MM3144.01 Nalidixic Acid Methyl Ester 63475-29-6 100mg O

O O

N N
MM3144.01-
Nalidixic Acid Methyl Ester 63475-29-6 25mg O
0025
O O

MM3144.02- N N

Nalidixic Acid Ethyl Ester 33331-59-8 25mg O


0025
O O

MM3144.03- N N

Nalidixic Acid Isopropyl Ester n/a 25mg O


0025
O O

Nalorphine Hydrochloride
N

MM1013.00 Nalorphine Hydrochloride 57-29-4 100mg H HCl

HO O OH

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-420
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Naloxone Hydrochloride Dihydrate


N
HCl

MM0272.00 Naloxone Hydrochloride Dihydrate 51481-60-8 250mg HO


H2O
2

HO O O

H
N
Impurity A (EP) as Hydrochloride: 4,5 -Epoxy-3,14-
HO HCl
MM0673.03 dihydroxymorphinan-6-one Hydrochloride (Noroxymorphone 52446-24-9 100mg
Hydrochloride) HO O O

H
N

MM0673.03- Impurity A (EP) as Hydrochloride: 4,5 -Epoxy-3,14-


HO HCl
dihydroxymorphinan-6-one Hydrochloride (Noroxymorphone 52446-24-9 25mg
0025 Hydrochloride) HO O O

MM0272.10- Impurity B (EP): 4,5 -Epoxy-14-hydroxy-17-(prop-2-enyl)-3- HO


1352085-46-1 25mg
0025 (prop-2-enyloxy)morphinan-6-one (3-O-Allylnaloxone) O O O

O +
N

MM0272.03 Naloxone N-Oxide 112242-14-5 100mg HO

HO O O

O +
N

MM0272.03-
Naloxone N-Oxide 112242-14-5 25mg HO

0025
HO O O

Naltrexone Hydrochloride
N

MM0233.00 Naltrexone Hydrochloride 16676-29-2 100mg HO HCl

HO O O

HO
MM0233.04 Naltrexone 16590-41-3 250mg
HO O O

H
N
Impurity B (EP) as Hydrochloride: 4,5 -Epoxy-3,14-
HO HCl
MM0673.03 dihydroxymorphinan-6-one Hydrochloride (Noroxymorphone 52446-24-9 100mg
Hydrochloride) HO O O

H
N
Impurity B (EP) as Hydrochloride: 4,5 -Epoxy-3,14-
MM0673.03- HO HCl
dihydroxymorphinan-6-one Hydrochloride (Noroxymorphone 52446-24-9 25mg
0025
Hydrochloride) HO O O

N
7-Naltrexone (7,8-Didehydronaltrexone; (5 )-17-
HO
MM0233.08 (Cyclopropylmethyl)-7,8-didehydro-4,5-epoxy-3,14- 123086-68-0 25mg
dihydroxymorphinan-6-one) HO O O

Nandrolone
OH

H H
MM0660.00 Nandrolone 434-22-0 250mg
H H
O

19-Norandrost-4-ene-3,17-dione H H
MM0660.01
(Estr-4-ene-3,17-dione)
734-32-7 100mg
H H
O

MM0660.01- 19-Norandrost-4-ene-3,17-dione H H

(Estr-4-ene-3,17-dione)
734-32-7 25mg
0025 H H
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-421
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH

H
MM0123.15 Estradiol 3-Methyl Ether 1035-77-4 100mg
H H
O

OH

MM0123.15- H
Estradiol 3-Methyl Ether 1035-77-4 25mg
0025 H H
O

Nandrolone Decanoate
O
O

MM0982.00 Nandrolone Decanoate 360-70-3 100mg H

H
H

H
O

OH

Impurity D (EP): 17 -Hydroxyestr-4-en-3-one H H


MM0660.00 434-22-0 250mg
(Nandrolone) H H
O

Nandrolone Phenpropionate
O

MM1786.00 Nandrolone Phenpropionate 62-90-8 250mg H H

H H
O

Naphazoline Hydrochloride
HN

MM0075.00- N
Naphazoline Hydrochloride 550-99-2 250mg HCl

0250

Impurity A (EP) as Hydrochloride: N-(2-


Aminoethyl)-2-(naphthalen-1-yl)acetamide O

Hydrochloride (Naphthylacetylethylenediamine N
H
NH2

HCl

Hydrochloride)
MM0075.06 73664-32-1 100mg
Related compound A (USP): N-(2-Aminoethyl)-2-
(naphthalen-1-yl)acetamide
Impurity A (EP) as Hydrochloride: N-(2-
Aminoethyl)-2-(naphthalen-1-yl)acetamide O

MM0075.06- Hydrochloride (Naphthylacetylethylenediamine N


H
NH2

HCl

Hydrochloride)
73664-32-1 25mg
0025
Related compound A (USP): N-(2-Aminoethyl)-2-
(naphthalen-1-yl)acetamide
O

OH
Impurity B (EP): (Naphthalen-1-yl)acetic Acid
MM0075.02 86-87-3 100mg
(1-Naphthylacetic Acid)

OH
MM0075.02- Impurity B (EP): (Naphthalen-1-yl)acetic Acid
86-87-3 25mg
0025 (1-Naphthylacetic Acid)

Impurity C (EP): (Naphthalen-1-yl)acetonitrile


MM0075.04 132-75-2 100mg
(1-Naphthylacetonitrile)

MM0075.04- Impurity C (EP): (Naphthalen-1-yl)acetonitrile


132-75-2 25mg
0025 (1-Naphthylacetonitrile)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-422
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity D (EP) as Hydrochloride: 2-(Naphthalen-2- HN N

MM0075.03 ylmethyl)-4,5-dihydro-1H-imidazole Hydrochloride ( - 6028-15-5 50mg HCl

Naphazoline Hydrochloride)
O

O
MM0075.05 Ethyl (1-Naphthyl)acetate 2122-70-5 100mg

N H2
(Naphthalen-1-yl)acetamide
MM0075.07
(1-Naphthylacetamide)
86-86-2 100mg

N H2
MM0075.07- (Naphthalen-1-yl)acetamide
(1-Naphthylacetamide)
86-86-2 25mg
0025

Naphazoline Nitrate
HN

N O
MM0286.00 Naphazoline Nitrate 5144-52-5 500mg HO N
+

Impurity A (EP) as Hydrochloride: N-(2-


Aminoethyl)-2-(naphthalen-1-yl)acetamide O

Hydrochloride (Naphthylacetylethylenediamine N
H
NH2

HCl
MM0075.06
Hydrochloride)
73664-32-1 100mg
Related compound A (USP): N-(2-Aminoethyl)-2-
(naphthalen-1-yl)acetamide
Impurity A (EP) as Hydrochloride: N-(2-
Aminoethyl)-2-(naphthalen-1-yl)acetamide O

MM0075.06- Hydrochloride (Naphthylacetylethylenediamine N


H
NH2

HCl

Hydrochloride)
73664-32-1 25mg
0025
Related compound A (USP): N-(2-Aminoethyl)-2-
(naphthalen-1-yl)acetamide
O

OH
Impurity B (EP): (Naphthalen-1-yl)acetic Acid
MM0075.02 86-87-3 100mg
(1-Naphthylacetic Acid)

OH
MM0075.02- Impurity B (EP): (Naphthalen-1-yl)acetic Acid
86-87-3 25mg
0025 (1-Naphthylacetic Acid)

Impurity C (EP): (Naphthalen-1-yl)acetonitrile


MM0075.04 132-75-2 100mg
(1-Naphthylacetonitrile)

MM0075.04- Impurity C (EP): (Naphthalen-1-yl)acetonitrile


132-75-2 25mg
0025 (1-Naphthylacetonitrile)

O
MM0075.05 Ethyl (1-Naphthyl)acetate 2122-70-5 100mg

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-423
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N H2
(Naphthalen-1-yl)acetamide
MM0075.07
(1-Naphthylacetamide)
86-86-2 100mg

N H2
MM0075.07- (Naphthalen-1-yl)acetamide
(1-Naphthylacetamide)
86-86-2 25mg
0025

Naproxen
OH
MM0152.00 Naproxen 22204-53-1 500mg O
O

Impurity A (EP): (2S)-2-(6-Hydroxynaphthalen- OH


MM0152.06 52079-10-4 100mg
2-yl)propanoic Acid (O-Demethylnaproxen) HO
O

MM0152.06- Impurity A (EP): (2S)-2-(6-Hydroxynaphthalen- OH


52079-10-4 25mg
0025 2-yl)propanoic Acid (O-Demethylnaproxen) HO
O

Impurity B (EP): (2S)-2-(5-Chloro-6-methoxy- OH

MM0152.09 naphthalen-2-yl)propanoic Acid 89617-86-7 100mg O


O

(5-Chloronaproxen) Cl

MM0152.09- Impurity B (EP): (2S)-2-(5-Chloro-6-methoxy- OH

naphthalen-2-yl)propanoic Acid 89617-86-7 25mg O


O
0025 (5-Chloronaproxen) Cl

Impurity C (EP): (2S)-2-(5-Bromo-6-methoxy- OH

MM0152.10 naphthalen-2-yl)propanoic Acid 84236-26-0 100mg O


O

(5-Bromonaproxen) Br

MM0152.10- Impurity C (EP): (2S)-2-(5-Bromo-6-methoxy- OH

naphthalen-2-yl)propanoic Acid 84236-26-0 25mg O


O
0025 (5-Bromonaproxen) Br

Impurity D (EP): (2S)-2-(5-Iodo-6-methoxy- OH

MM0152.11 naphthalen-2-yl)propanoic Acid 116883-62-6 100mg O


O

(5-Iodonaproxen) I

MM0152.11- Impurity D (EP): (2S)-2-(5-Iodo-6-methoxy- OH

naphthalen-2-yl)propanoic Acid 116883-62-6 25mg O


O
0025 (5-Iodonaproxen) I

Impurity E (EP): Methyl (2S)-2-(6-Methoxynaphthalen-2-yl) O


MM0152.02 propanoate (Naproxen Methyl Ester) 26159-35-3 100mg O
Related compound E (USP) O

MM0152.02- Impurity E (EP): Methyl (2S)-2-(6-Methoxynaphthalen-2-yl) O


propanoate (Naproxen Methyl Ester) 26159-35-3 25mg O
0025 Related compound E (USP) O

Impurity F (EP): Ethyl (2S)-2-(6-Methoxy-


O
MM0152.12 naphthalen-2-yl)propanoate (Naproxen 31220-35-6 100mg O
O
Ethyl Ester)
Impurity F (EP): Ethyl (2S)-2-(6-Methoxy-
MM0152.12- O
naphthalen-2-yl)propanoate (Naproxen 31220-35-6 25mg O
O
0025 Ethyl Ester)
Impurity G (EP): (2R)-2-(6-Methoxynaphthalen-2-yl)
propanoic Acid ((R)-Naproxen) OH

Related compound G (USP): (R)-2-(6-Methoxynaphthalen-


MM0152.25 23979-41-1 100mg O
O

2-yl)propanoic acid
Impurity G (EP): (2R)-2-(6-Methoxynaphthalen-2-yl)
MM0152.25- propanoic Acid ((R)-Naproxen) OH

Related compound G (USP): (R)-2-(6-Methoxynaphthalen-


23979-41-1 25mg O
0025 O

2-yl)propanoic acid
OH
Impurity H (EP): 6-Methoxynaphthalen-2-ol
MM0152.14 5111-66-0 100mg
(Hydroxynerolin) O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-424
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

OH
MM0152.14- Impurity H (EP): 6-Methoxynaphthalen-2-ol
5111-66-0 25mg
0025 (Hydroxynerolin) O

Impurity I (EP): (6-Methoxynaphthalen-2- OH

MM0152.01 23981-47-7 100mg O


yl)acetic Acid ( -Demethylnaproxen) O

MM0152.01- Impurity I (EP): (6-Methoxynaphthalen-2- OH

23981-47-7 25mg O
0025 yl)acetic Acid ( -Demethylnaproxen) O

Impurity J (EP): 2-Ethyl-6-methoxynaphthalene


MM0152.18 21388-17-0 100mg
(Ethylnerolin) O

MM0152.18- Impurity J (EP): 2-Ethyl-6-methoxynaphthalene


21388-17-0 25mg
0025 (Ethylnerolin) O

Impurity K (EP): (1RS)-1-(6-Methoxynaphthalen- OH


2-yl)ethanol
Related compound K (USP): 1-(6-Methoxynaphthalen-2-yl)
MM0152.16 77301-42-9 100mg
O
ethanol
Impurity K (EP): (1RS)-1-(6-Methoxynaphthalen- OH
MM0152.16- 2-yl)ethanol
Related compound K (USP): 1-(6-Methoxynaphthalen-2-yl)
77301-42-9 25mg
0025 O
ethanol
Impurity L (EP): 1-(6-Methoxynaphthalen-2- O
yl)ethanone (Acetylnerolin)
MM0152.07
Related compound L (USP): 1-(6-methoxynaphthalen-2-yl)
3900-45-6 100mg
O
ethanone
Impurity L (EP): 1-(6-Methoxynaphthalen-2- O
MM0152.07- yl)ethanone (Acetylnerolin)
Related compound L (USP): 1-(6-methoxynaphthalen-2-yl)
3900-45-6 25mg
0025 O
ethanone

Impurity M (EP): 2-Methoxynaphthalene


MM0152.08 93-04-9 100mg
(Nerolin) O

MM0152.08- Impurity M (EP): 2-Methoxynaphthalene


93-04-9 25mg
0025 (Nerolin) O

Br

MM0152.17 Impurity N (EP): 2-Bromo-6-methoxynaphthalene 5111-65-9 100mg


O

Br
MM0152.17-
Impurity N (EP): 2-Bromo-6-methoxynaphthalene 5111-65-9 25mg
0025 O

Impurity O (EP): 6-Methoxynaphthalene-2-carboxylic Acid (6- O

Methoxy-2-naphthoic Acid; 2-Carboxy-6- OH


MM0152.15 2471-70-7 100mg
methoxynaphthalene) O
Related compound A (USP): 6-methoxy-2-naphthoic acid
Impurity O (EP): 6-Methoxynaphthalene-2-carboxylic Acid (6- O
MM0152.15- Methoxy-2-naphthoic Acid; 2-Carboxy-6- OH
2471-70-7 25mg
0025 methoxynaphthalene) O
Related compound A (USP): 6-methoxy-2-naphthoic acid
O +

MM0152.04 Naproxen Sodium 26159-34-2 500mg O


Na

OH
MM0152.19 rac-Naproxen 23981-80-8 100mg O
O

MM0152.19- OH
rac-Naproxen 23981-80-8 25mg O
0025 O

O
MM0152.20 Naproxen Isopropyl Ester 156967-24-7 100mg O
O

MM0152.20- O
Naproxen Isopropyl Ester 156967-24-7 25mg O
0025 O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-425
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

O OH
Naproxen 1,3-Butylene Glycol Esters (Mixture of Regio- and O

MM0152.21 n/a 100mg


O OH
Stereoisomers)
O
O

OH
MM0152.22- O
Naproxen 2,3-Butylene Glycol Ester n/a 25mg O
0025 O

OH
O

O
Naproxen 1,2-Propylene Glycol Esters (Mixture of Regio- and O

MM0152.23 n/a 100mg


Stereoisomers) O
OH
O
O

OH
O OH

O
Naproxen 1,2,3-Propanetriol Esters (Mixture of Regio- and O

MM0152.24 n/a 100mg


Stereoisomers) O
OH
O
O OH

OH
O OH

O
MM0152.24- Naproxen 1,2,3-Propanetriol Esters (Mixture of Regio- and O

n/a 25mg
0025 Stereoisomers) O
OH
O
O OH

MM0152.28- N
2-(6-Methoxy-2-naphthyl)acetonitrile 71056-96-7 25mg O
0025

Naratriptan Hydrochloride
H
N
H
N

MM0299.00 Naratriptan Hydrochloride 143388-64-1 250mg


S
O O HCl

H
N

3-(1-Methylpiperidin-4-yl)-1H-indole
MM0299.09 Related compound A (USP): 3-(1-Methylpiperidin-4-yl)-1H- 17403-07-5 100mg
indole
N

H
N

3-(1-Methylpiperidin-4-yl)-1H-indole
MM0299.09-
Related compound A (USP): 3-(1-Methylpiperidin-4-yl)-1H- 17403-07-5 25mg
0025
indole
N

H
N
N-Methyl-1H-indole-5-ethanesulfonamide (2-(1H-Indol-5-yl)- H
MM0299.10 98623-50-8 100mg N
S
N-methylethanesulfonamide) O O

H
N
MM0299.10- N-Methyl-1H-indole-5-ethanesulfonamide (2-(1H-Indol-5-yl)- H
98623-50-8 25mg N
S
0025 N-methylethanesulfonamide) O O

Nateglinide

O
H
N
MM0847.00 Nateglinide 105816-04-4 100mg O
OH

Impurity A (EP): trans-4-(1-Methylethyl)


MM0847.02 cyclohexanecarboxylic Acid
7077-05-6 100mg OH
Related compound A (USP): trans-4-
isopropylcyclohexanecarboxylic acid O

Impurity A (EP): trans-4-(1-Methylethyl)


MM0847.02- cyclohexanecarboxylic Acid
7077-05-6 25mg OH
0025 Related compound A (USP): trans-4-
isopropylcyclohexanecarboxylic acid O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-426
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity B (EP): N-[[trans-4-(1-Methylethyl)cyclohexyl]


MM0847.03- carbonyl]-L-phenylalanine (Nateglinide L-Phenylalanine H
N
O

Isomer) 105816-05-5 25mg O


OH

0025 Related compound B (USP): N-(trans-4-


isopropylcyclohexanecarbonyl)-L-phenylalanine
NH2
Impurity D (EP): (2S)-2-Amino-3-phenylpropanoic Acid OH
MM1560.00 63-91-2 250mg
(Phenylalanine)
O

O
H
Impurity E (EP): N-[(trans-4-Ethylcyclohexyl)carbonyl]-D- N
OH
MM0847.04 105746-45-0 50mg
phenylalanine (Nateglinide Ethyl Analog) O

Impurity F (EP) as Dicyclohexylammonium Salt: N-[[trans-4- N

MM0847.09- (1-Methylethyl)cyclohexyl]carbonyl]-D-phenylalanyl-D- H
N
O
OH
n/a 25mg
0025 phenylalanine Dicyclohexylammonium Salt (Nateglinide IPP O
N
H
O

Impurity Dicyclohexylammonium Salt)


O
Impurity G (EP): Ethyl N-[[trans-4-(1-Methylethyl)cyclohexyl] H
N
O
MM0847.06 187728-85-4 50mg
carbonyl]-D-phenylalaninate (Nateglinide Ethyl Ester) O

NH2

MM0314.03 Phenylalanine 150-30-1 100mg OH

NH2
MM0314.03-
Phenylalanine 150-30-1 25mg OH
0025 O

O
H
MM0847.10- N
O
Nateglinide Methyl Ester 105746-47-2 25mg O
0025

O
H
MM0847.11- N
O
Nateglinide Isopropyl Ester n/a 25mg O
0025

Nebivolol Hydrochloride
AND Enantiomer
OH OH

Nebivolol Hydrochloride
H H H
O N O

MM0947.00 152520-56-4 250mg F HCl F

O
MM0947.01- O
OH
6-Fluoro-3,4-dihydro-2H-1-benzopyran-2-carboxylic Acid 99199-60-7 25mg
0025 F

OH
MM0947.02- (1S,2R)-2-(2-Benzylamino-1-hydroxyethyl)-6-fluorochromane H H
N O
129050-27-7 25mg
0025 F

Nefazodone Hydrochloride
N
N N

MM0591.00 Nefazodone Hydrochloride 82752-99-6 250mg O


N
O
N Cl
HCl

O
N +
MM0591.02- N N
N N Cl
Nefazodone N-Oxide 2724726-95-6 25mg O
O
0025

Nefopam Hydrochloride

O
MM1189.00 Nefopam Hydrochloride 23327-57-3 100mg HCl

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-427
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Neohesperidin-dihydrochalcone
OH
O O OH O
HO

HO O

MM3398.00 Neohesperidin-dihydrochalcone 20702-77-6 250mg OH

O
OH
OH
O

OH
OH

Neostigmine Bromide
O

MM1568.00 Neostigmine Bromide 114-80-7 250mg N O N


+
Br

MM1568.01- Impurity A (EP) as Bromide: 3-Hydroxy-N,N,N- Br


1620-19-5 25mg +
HO N
0025 trimethylanilinium Bromide

Neostigmine Metilsulfate
O O O

MM0857.00 Neostigmine Metilsulfate 51-60-5 250mg N O N


+
S
O O

Nevirapine

N N N
MM1146.00-
Nevirapine Anhydrous 129618-40-2 250mg
0250
N
H
O

Impurity A (EP): 11-Ethyl-4-methyl-5,11-dihydro- N N


N
6H-dipyrido [3,2-b:2',3'-e][1,4]diazepin-6-one
MM1146.01
Related compound A (USP): 5,11-dihydro-6H-11-ethyl-4-
133627-17-5 100mg
N
methyl-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one O
H

Impurity A (EP): 11-Ethyl-4-methyl-5,11-dihydro- N N


N
MM1146.01- 6H-dipyrido [3,2-b:2',3'-e][1,4]diazepin-6-one
Related compound A (USP): 5,11-dihydro-6H-11-ethyl-4-
133627-17-5 25mg
0025 N
methyl-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one O
H

Impurity B (EP): 4-Methyl-5,11-dihydro-6H- N H


N N

dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one
MM1146.02
Related compound B (USP): 5,11-Dihydro-4-methyl-6H-
287980-84-1 100mg
N
H
dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one O

Impurity B (EP): 4-Methyl-5,11-dihydro-6H- N H


N N
MM1146.02- dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one
Related compound B (USP): 5,11-Dihydro-4-methyl-6H-
287980-84-1 25mg
0025 N
H
dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one O

Impurity C (EP): 4-Methyl-11-propyl-5,11-dihydro-


6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one N N N

Related compound C (USP): 5,11-Dihydro-6H-11-propyl-4-


MM1146.03 287980-85-2 100mg
methyl-dipyrido[3,2-b:2',3'-e] [1,4]diazepin-6-one N
H
O

Impurity C (EP): 4-Methyl-11-propyl-5,11-dihydro-


MM1146.03- 6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one N N N

Related compound C (USP): 5,11-Dihydro-6H-11-propyl-4-


287980-85-2 25mg
0025
methyl-dipyrido[3,2-b:2',3'-e] [1,4]diazepin-6-one N
H
O

Cl N
MM1146.04-
3-Amino-2-chloro-4-methylpyridine 133627-45-9 25mg
0025 H 2N

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-428
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

N Cl
Cl
2-Chloro-N-(2-chloro-4-methyl-3-pyridinyl)-3- H
N
MM1146.05 133627-46-0 100mg N
pyridinecarboxamide O

N Cl
Cl
MM1146.05- 2-Chloro-N-(2-chloro-4-methyl-3-pyridinyl)-3- H
N
133627-46-0 25mg N
0025 pyridinecarboxamide O

O
+
N N N
MM1146.06-
Nevirapine N10-Oxide 1027324-99-7 25mg
0025
N
H
O

O
+
N N N
MM1146.07-
Nevirapine N1-Oxide 162255-73-4 25mg
0025
N
H
O

Niacin, see Nicotinic Acid

Niacinamide, see Nicotinamide

Niaouli Oil
O

MM0877.19 Methyleugenol 93-15-2 100mg


O

Nicardipine Hydrochloride
H
N

O O
N

MM0465.00 Nicardipine Hydrochloride 54527-84-3 250mg O O

+O
HCl

N
O

Impurity A (EP) as Dihydrochloride: 2-[Benzyl(methyl)amino]


N
ethyl Methyl 2,6-Dimethyl-4-(3-nitrophenyl)pyridine-3,5- O O
N
O O
MM0465.01 dicarboxylate Dihydrochloride (3-Methyl 5-[Methyl n/a 100mg +O
N HCl
2
O
(phenylmethyl)amino]ethyl 2,6-Dimethyl-4-(3-nitrophenyl)
pyridine-3,5-dicarboxylate Dihydrochloride)
Impurity A (EP) as Dihydrochloride: 2-[Benzyl(methyl)amino]
N
ethyl Methyl 2,6-Dimethyl-4-(3-nitrophenyl)pyridine-3,5- O O
MM0465.01- N
O O
dicarboxylate Dihydrochloride (3-Methyl 5-[Methyl n/a 25mg +O
0025 N HCl
2
O
(phenylmethyl)amino]ethyl 2,6-Dimethyl-4-(3-nitrophenyl)
pyridine-3,5-dicarboxylate Dihydrochloride)
H
N

Impurity C (EP): Dimethyl 2,6-Dimethyl-4-(3-nitrophenyl)-1,4- O O

MM0092.01 dihydropyridine-3,5-dicarboxylate 21881-77-6 100mg O O

Related compound C (USP) + O


N
O

H
N

Impurity C (EP): Dimethyl 2,6-Dimethyl-4-(3-nitrophenyl)-1,4- O O


MM0092.01-
dihydropyridine-3,5-dicarboxylate 21881-77-6 25mg O O
0025
Related compound C (USP) + O
N
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-429
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

H
N

O O +
N
O O O
MM0465.04 Nicardipine N-Oxide n/a 100mg
+O
N
O

H
N

O O +
MM0465.04- N
O O O
Nicardipine N-Oxide n/a 25mg
0025 +O
N
O

Nicergoline
Br
H
N
MM0115.00-
Nicergoline 27848-84-6 250mg N

O
O N

0250 O

Impurity A (EP): [(6aR,9R,10aS)-10a-Methoxy- H


Cl

4,7-dimethyl-4,6,6a,7,8,9,10,10a-octahydro- N
N

O N
MM0115.02 38536-28-6 50mg
indolo[4,3-fg]quinolin-9-yl]methyl 5-Chloro- O
O

pyridine-3-carboxylate (Chloronicergoline)
Impurity C (EP): [(6aR,9R,10aS)-10a-Methoxy- H
N
4,7-dimethyl-4,6,6a,7,8,9,10,10a-octahydro- N
OH
MM0115.04 35155-28-3 100mg
indolo[4,3-fg]quinolin-9-yl]methanol O

(Methylmethoxylumilysergol)
Impurity C (EP): [(6aR,9R,10aS)-10a-Methoxy- H
N
MM0115.04- 4,7-dimethyl-4,6,6a,7,8,9,10,10a-octahydro- N
OH
35155-28-3 25mg
0025 indolo[4,3-fg]quinolin-9-yl]methanol O

(Methylmethoxylumilysergol)
Br

Impurity D (EP): 5-Bromopyridine-3-carboxylic


MM0115.06 20826-04-4 100mg
Acid HO N

Br

MM0115.06- Impurity D (EP): 5-Bromopyridine-3-carboxylic


20826-04-4 25mg
0025 Acid HO N

O
H +
N
MM0115.09- N
Methylmethoxylumilysergol N-Oxide n/a 25mg OH
0025 O

Niclosamide
O
+
Cl N
O O
MM0361.00 Niclosamide 50-65-7 250mg Cl
N
H
OH

Nicoboxil
O
O
O N
MM3800.00 Nicoboxil 13912-80-6 100mg

Nicorandil
O
O +O
MM0924.00 Nicorandil 65141-46-0 100mg N
H
N
O
N

Nicotinaldehyde Thiosemicarbazone
H
N N H2
MM1801.00 Nicotinaldehyde Thiosemicarbazone 555-90-8 100mg N N
S

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-430
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Nicotinamide (Niacinamide)
O
MM0552.00-
Nicotinamide 98-92-0 250mg N NH2
0250

O
MM0552.03- N
Impurity C (EP): Pyridine-2-carboxamide (Picolinamide) 1452-77-3 25mg NH2
0025

O
MM0552.02- Impurity E (EP): Pyridine-3-carboxamide 1-Oxide O +
1986-81-8 25mg N NH2
0025 (Nicotinamide N-Oxide)

MM0552.01 Isonicotinamide 1453-82-3 100mg NH2


N

O
MM0552.01-
Isonicotinamide 1453-82-3 25mg NH2
0025 N

O
+
MM0552.05 1-Methylnicotinamide Iodide 6456-44-6 100mg N NH2 I

O
MM0552.05- +
1-Methylnicotinamide Iodide 6456-44-6 25mg N NH2 I
0025

O
MM0553.00-
Nicotinic Acid 59-67-6 250mg N OH
0250

O
OH
MM0553.13 Nicotinuric Acid 583-08-4 100mg N N
H
O

O
MM0553.13- OH
Nicotinuric Acid 583-08-4 25mg N N
H
0025 O

O
MM0552.06-
N-Methylnicotinamide 114-33-0 25mg N N
0025 H

O
MM0552.07- N NH2
6-Aminonicotinamide 329-89-5 25mg
0025 H2 N

Nicotine

MM0517.00-
Nicotine [for single use] 54-11-5 100mg N N
100

OH O
N N HO H 2O
OH
MM1522.00 Nicotine Ditartrate Dihydrate 6019-06-3 250mg O OH
2
2

Impurity A (EP) as Racemate: (2RS)-1,2,3,6-Tetrahydro-2,3'-


bipyridyl ((RS)-Anatabine)
MM0517.11 2743-90-0 100mg N N
Related compound A (USP): 1,2,3,6-tetrahydro-2,3'- H
bipyridine

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-431
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Impurity B (EP): 3-(1-Methyl-1H-pyrrol-2-yl)pyridine ( -


Nicotyrine) N N
Related compound B (USP): 3-(1-methyl-1H-pyrrol-2-yl)
MM0517.06 487-19-4 100mg
pyridine
Impurity C (EP): (5S)-1-Methyl-5-(pyridin-3-yl)pyrrolidin-2-
one ((-)-Cotinine) N N O
Related compound C (USP): (S)-1-methyl-5-(pyridin-3-yl)
MM0517.03 486-56-6 100mg
pyrrolidin-2-one
Impurity D (EP): 3-(4,5-Dihydro-3H-pyrrol-2-yl)pyridine
(Myosmine) N N
MM0517.02
Related compound D (USP): 3-(4,5-dihydro-3H-pyrrol-2-yl)
532-12-7 100mg
pyridine
Impurity D (EP): 3-(4,5-Dihydro-3H-pyrrol-2-yl)pyridine
MM0517.02- (Myosmine) N N
Related compound D (USP): 3-(4,5-dihydro-3H-pyrrol-2-yl)
532-12-7 25mg
0025
pyridine
Impurity E (EP): (1RS,2S)-1-Methyl-2-(pyridin-3-yl)pyrrolidine
1-Oxide (Nicotine N -Oxide) N N
+
MM0517.07
Related compound E (USP): (1RS,2S)-1-methyl-2-(pyridin-
491-26-9 100mg
O
3-yl)pyrrolidine 1-oxide

Impurity F (EP) as Racemate: 3-[(2RS)-Pyrrolidin-2-yl]


MM0517.13 pyridine ((RS)-Nornicotine) 5746-86-1 100mg N N
H
Related compound F (USP): 3-(pyrrolidin-2-yl)pyridine

Impurity G (EP): 3-[(2S)-Piperidin-2-yl]pyridine


MM0517.01 (Anabasine) 494-52-0 100mg N N
H
Related compound G (USP): (S)-3-(piperidin-2-yl)pyridine

Impurity G (EP) as Racemate: 3-[(2RS)-Piperidin-2-yl]


MM0517.10 13078-04-1 100mg N N
pyridine ((RS)-Anabasine) H

3-[(1S,2S)-1-Methyl-1-oxidopyrrolidin-2-yl]pyridine (Nicotine +
MM0517.08 51095-86-4 50mg N N
cis-N'-Oxide) O

N N O
MM0517.14 (5RS)-5-(Pyridin-3-yl)pyrrolidin-2-one ((RS)-Norcotinine) 17708-87-1 100mg H

MM0517.14- N N O
(5RS)-5-(Pyridin-3-yl)pyrrolidin-2-one ((RS)-Norcotinine) 17708-87-1 25mg H
0025

MM0517.15 3-(1H-Pyrrol-2-yl)pyridine (ß-Nornicotyrine) 494-98-4 100mg N N


H

MM0517.15- N
3-(1H-Pyrrol-2-yl)pyridine (ß-Nornicotyrine) 494-98-4 25mg N
0025 H

N
MM0517.16 (RS)-1-Methyl-3-nicotinoylpyrrolidine ((RS)-MNP) 125630-26-4 100mg
N

O
H
Pseudooxynicotine Dihydrochloride (4-(Methylamino)-1-(3- N
N
HCl
MM0517.17 66093-90-1 100mg 2

pyridyl)butan-1-one Dihydrochloride)
O
MM0517.17- H
Pseudooxynicotine Dihydrochloride (4-(Methylamino)-1-(3- N
N
HCl
66093-90-1 25mg 2

0025 pyridyl)butan-1-one Dihydrochloride)

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-432
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

Mixed
(1RS,2S)-Nicotine N,N'-Dioxide (3-[(1RS,2S)-1-Methyl-1- O &1
MM0517.19 2055-29-0 100mg + +
N N
oxidopyrrolidin-2-yl]pyridine 1-Oxide)
O

Nicotine Ditartrate Dihydrate


OH O

MM1522.00 Nicotine Ditartrate Dihydrate 6019-06-3 250mg N N HO

O OH
OH

2
H 2O
2

Nicotinic Acid (Niacin)


O
MM0553.00-
Nicotinic Acid 59-67-6 250mg N OH
0250

O
MM0553.05- Impurity A (EP): 6-Methylpyridine-3-carboxylic Acid (6-
3222-47-7 25mg N OH
0025 Methylnicotinic Acid)

N OH
Impurity B (EP): 2,2'-Bipyridine-5,5'-dicarboxylic
MM0553.06 1802-30-8 100mg
Acid (6,6'-Dinicotinic Acid) HO N

N OH
MM0553.06- Impurity B (EP): 2,2'-Bipyridine-5,5'-dicarboxylic
1802-30-8 25mg
0025 Acid (6,6'-Dinicotinic Acid) HO N

MM0553.07- N
Impurity C (EP): 5-Ethyl-2-methylpyridine 104-90-5 100mg
0100
O

MM0553.08- N OH
Impurity D (EP): Pyridine-2,5-dicarboxylic Acid 100-26-5 25mg HO
0025
O

N
Impurity E (EP): Pyridine-4-carboxylic Acid OH
MM0553.03 55-22-1 100mg
(Isonicotinic Acid)
O

N
MM0553.03- Impurity E (EP): Pyridine-4-carboxylic Acid OH
55-22-1 25mg
0025 (Isonicotinic Acid)
O

O
+
N
MM0553.11 Impurity H (EP): 3-Nitropyridine 2530-26-9 100mg N O

O
+
MM0553.11- N
Impurity H (EP): 3-Nitropyridine 2530-26-9 25mg N O
0025

O
+
N
N O
MM0553.12-
Impurity I (EP): 3,5-Dinitropyridine 940-06-7 25mg
0025
+
N
O O

MM0549.00 Methyl Nicotinate 93-60-7 500mg N O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-433
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0104.00 Benzyl Nicotinate 94-44-0 500mg N O

O
OH
MM0553.13 Nicotinuric Acid 583-08-4 100mg N N
H
O

O
MM0553.13- OH
Nicotinuric Acid 583-08-4 25mg N N
H
0025 O

O
MM0533.02-
Isopropyl Nicotinate 553-60-6 100mg N O
0100

MM0553.14- N
3-Ethylpyridine 536-78-7 100mg
0100

MM0553.15 6-Hydroxynicotinic Acid 5006-66-6 100mg N OH

HO

O
MM0553.15- N OH
6-Hydroxynicotinic Acid 5006-66-6 25mg
0025
HO

MM1756.00 Ethyl Nicotinate 614-18-6 250mg N O

Nifedipine
H
N

O O
MM0003.00-
Nifedipine 21829-25-4 250mg O O
O
+
0250 N
O

Impurity A (EP): Dimethyl 2,6-Dimethyl-4-(2- O O

MM0003.02 nitrophenyl)pyridine-3,5-dicarboxylate 67035-22-7 100mg O O


N
O
+

(Nitrophenylpyridine Analogue of Nifedipine) O

MM0003.02- Impurity A (EP): Dimethyl 2,6-Dimethyl-4-(2- O O

nitrophenyl)pyridine-3,5-dicarboxylate 67035-22-7 25mg O O


N
O
+
0025 (Nitrophenylpyridine Analogue of Nifedipine) O

Impurity B (EP): Dimethyl 2,6-Dimethyl-4-(2- O O

MM0003.01 nitrosophenyl)pyridine-3,5-dicarboxylate 50428-14-3 100mg O O


N
(Nitrosophenylpyridine Analogue of Nifedipine) O

MM0003.01- Impurity B (EP): Dimethyl 2,6-Dimethyl-4-(2- O O

nitrosophenyl)pyridine-3,5-dicarboxylate 50428-14-3 25mg O O


N
0025 (Nitrosophenylpyridine Analogue of Nifedipine) O

O
Impurity C (EP) as E/Z-Mixture: Methyl (E/Z)-2-(2- O
MM0003.07 39562-27-1 100mg +
Nitrobenzylidene)-3-oxobutanoate O N
O

O
MM0003.07- Impurity C (EP) as E/Z-Mixture: Methyl (E/Z)-2-(2- O
39562-27-1 25mg +

0025 Nitrobenzylidene)-3-oxobutanoate O N
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-434
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

H 2N

MM0003.08 Impurity D (EP): Methyl 3-Aminobut-2-enoate 14205-39-1 100mg O

H 2N
MM0003.08-
Impurity D (EP): Methyl 3-Aminobut-2-enoate 14205-39-1 25mg O
0025
O

O
O
+
N
MM0003.03 2-Nitrobenzaldehyde 552-89-6 100mg O

O
O
+
MM0003.03- N
2-Nitrobenzaldehyde 552-89-6 25mg O
0025

N
O
2-Hydroxymethyl-5-(methoxycarbonyl)-6-methyl-4-(2- O
MM0003.06- O O
nitrophenyl)pyridine-3-carboxylic Acid Lactone (Hydroxy 34785-00-7 25mg O
+
0025 N
O
Dehydro Nifedipine Lactone)

O O
MM0003.10-
Methyl Acetoacetate 105-45-3 100mg
0100 O

H
N

O O
Dimethyl 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-
MM0092.01 21881-77-6 100mg O O
3,5-dicarboxylate (m-Nifedipine) O
+
N
O

H
N

O O
MM0092.01- Dimethyl 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-
21881-77-6 25mg O O
0025 3,5-dicarboxylate (m-Nifedipine)
+ O
N
O

Niflumic Acid
F F

MM0850.00 Niflumic Acid 4394-00-7 250mg N NH

OH

N Cl

Impurity A (EP): 2-Chloropyridine-3-carboxylic OH


MM0915.01 2942-59-8 100mg
Acid (2-Chloronicotinic Acid)
O

N Cl

MM0915.01- Impurity A (EP): 2-Chloropyridine-3-carboxylic OH


2942-59-8 25mg
0025 Acid (2-Chloronicotinic Acid)
O

N OH
F F
Impurity B (EP): 2-Hydroxy-N-[3-(trifluoro- H
N
MM0850.05 72633-64-8 100mg F
methyl)phenyl]pyridine-3-carboxamide O

N OH
F F
MM0850.05- Impurity B (EP): 2-Hydroxy-N-[3-(trifluoro- H
N
72633-64-8 25mg F
0025 methyl)phenyl]pyridine-3-carboxamide O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-435
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

F F

F
MM0161.06 Impurity C (EP): 3-(Trifluoromethyl)aniline 98-16-8 100mg

N H2

F F

Impurity F (EP): Methyl 2-[[3-(Trifluoromethyl)-


MM0850.01 phenyl]amino]pyridine-3-carboxylate 59361-45-4 100mg N NH
(Niflumic Acid Methyl Ester)
O

F F

MM0850.01- Impurity F (EP): Methyl 2-[[3-(Trifluoromethyl)-


phenyl]amino]pyridine-3-carboxylate 59361-45-4 25mg N NH
0025 (Niflumic Acid Methyl Ester)
O

F F

MM0850.02-
Niflumic Acid Isopropyl Ester n/a 25mg N NH
0025
O

F F

MM0850.09-
Niflumic Acid Ethyl Ester 51703-19-6 25mg N NH
0025
O

Nifuratel
O
O
O
MM1021.00 Nifuratel 4936-47-4 50mg O
N
+ O
N
N
S

Nifuroxazide
OH
MM0574.00- O
H
Nifuroxazide 965-52-6 250mg O
N
+ O
N
N

O
0250
OH
Impurity A (EP): 4-Hydroxybenzohydrazide H
N
MM0574.01 5351-23-5 100mg H 2N
(p-Hydroxybenzohydrazide) O

OH
MM0574.01- Impurity A (EP): 4-Hydroxybenzohydrazide H
N
5351-23-5 25mg H 2N
0025 (p-Hydroxybenzohydrazide) O

O
MM0431.00- Impurity B (EP): Methyl 4-Hydroxybenzoate (Methyl O
99-76-3 250mg
0250 Parahydroxybenzoate)
HO

Impurity C (EP): (5-Nitrofuran-2-yl)methylidene O O


MM0943.02 Diacetate ((5-Nitrofuran-2-yl)methylene 92-55-7 100mg O
N
+
O
O
Diacetate)
O

ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-436
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit

MM0943.02- Impurity C (EP): (5-Nitrofuran-2-yl)methylidene O O


Diacetate ((5-Nitrofuran-2-yl)methylene 92-55-7 25mg O
N
+
O
O
0025 Diacetate)
O

Nifursol
O
O OH O +
+ N
N N
O N O O

MM0444.00 Nifursol 16915-70-1

You might also like