Navana Pharmaceuticals Ltd.

PRODUCT DEVELOPMENT DEPARTMENT

Rupshi,Rupganj, Narayanganj, Bangladesh
LAB BATCH HISTORY- TABLET

Glucosamine Sulfate Potassium Chloride USP equivalent to

Product Name Glucosamine Sulfate 750 mg &Chondroitin Sulfate
Sodium USP equivalent to Chondroitin Sulfate 600 mg Tablet Batch No.
Each Tablet Contains Glucosamine Sulfate Potassium Chloride USP
Label Claim equivalent to Glucosamine Sulfate 750 mg &Chondroitin Sulfate
Sodium USP equivalent to Chondroitin Sulfate 600 mg
Batch Size 1.146 kg Batch Size (Nos.) 600 tablets Mfg. Date
(In Wt.)
Packaging Mode Alu-PVDC/ Alu-PVC/Alu-Alu
 Uncoated  SR  Film Coated  Enteric Coated
API Source:
Potency: % Glucosamine Sulfate Potassium Chloride:

Chondroitin Sulfate Sodium:

Formulation
Material QC Ref. Name of Materials Spec Qty/Unit Batch Actual Perce Done Checke
Code No. (mg) Qty (g) Qty (g) ntage By d by
(%)
Active Ingredients:
NAAC0631 Glucosamine USP 995.00 *597.00
Sulfate Potassium
Chloride
Chondroitin USP 660.00 *396.00
Sulfate Sodium
Excipients:
NEEX0191 Microcrystalline Cellulose BP 115.80 69.480 **
(Avicel PH 101)
NEEX0218 USP 34.00 20.400 20.400
Povidone K 30
NEEX0197 USP- 38.600 23.160 23.160
Crospovidone NF

NEEX0099 Croscarmellose BP 38.600 23.160 23.160

Sodium
NAAC0550 Anhydrous Dibasic USP 10.00 6.000 6.000
Calcium Phosphate
NEEX0032 Magnesium Stearate BP 3.00 1.800 1.800

NEEX0171 Colloidal Silicon Dioxide USP- 15.00 9.000 9.000

(Aerosil 200/Cab-O-Sil NF
M5P)
NEEX0029 Isopropyl Alcohol (IPA) BP

* Quantity based on 100% potency as Glucosamine Sulfate Potassium Chloride & Chondroitin Sulfate Sodium.
** Quantity of Microcrystalline Cellulose (Avicel PH 101) to be adjusted after potency calculation of Glucosamine
Sulfate Potassium Chloride & Chondroitin Sulfate Sodium including 4% of moisture overage
Prepared by: Checked by: Reviewed by: Approved by:

Azizur Rahman Mst. Asma Khatun Ayesha Zaman Mustafa Khalid Shams
Sr. Executive, PD Deputy Manager, PD Sr. Manager, PD Head of Plant

Page 1 of 7
 Navana Pharmaceuticals Ltd.
PRODUCT DEVELOPMENT DEPARTMENT
Rupshi,Rupganj, Narayanganj, Bangladesh
LAB BATCH HISTORY- TABLET

1. Calculation for the quantity of Glucosamine Sulfate Potassium Chloride as follows-

Required total theoretical quantity of Glucosamine Sulfate Potassium Chloride = g

g X 100.0
Quantity of Glucosamine Sulfate
Potassium Chloride as per potency = Declared Potency (%) as Glucosamine Sulfate Potassium Chloride

= X 100.0 = ________________g (X)

…………………………...(%)

2. Calculation for the quantity Chondroitin Sulfate Sodium as follows-

Required total theoretical quantity of Chondroitin Sulfate Sodium = g

g X 100.0
Quantity of Chondroitin Sulfate Sodium as per
potency = Declared Potency (%) as Chondroitin Sulfate Sodium

= X 100.0 = ________________g (Y)

…………………………... (%)
3. The Calculation for Microcrystalline Cellulose (Avicel PH 101) is as
Quantity of Microcrystalline Cellulose (Avicel PH 10) = g – (X+Y) g

= g= _______________ g

Calculated by: Checked by:

Prepared by: Checked by:

Azizur Rahman Mst. Asma Khatun

Sr. Executive, PD Deputy Manager, PD

Page 2 of 7
 Navana Pharmaceuticals Ltd.
PRODUCT DEVELOPMENT DEPARTMENT
Rupshi,Rupganj, Narayanganj, Bangladesh
LAB BATCH HISTORY- TABLET

Manufacturing steps:
Done Checke
Step Process Description
by d By
Step 1) Weigh accurately all the ingredients as per formulation.
Step 2) Soak the Povidone K30 in Isopropyl Alcohol (IPA).

Step 3) Sieve Glucosamine Sulfate Potassium Chloride & Chondroitin

Sulfate Sodium and Microcrystalline Cellulose (Avicel PH 101) through 20
mesh. Mix the dry powder for 5 minutes, then add step-2 into step-3 and mix
Granulation for 5 minutes to obtain a granulating mass.
Step 4) Discharge the wet granules and transfer into the tray Dryer. Dry the
granules at 55-650C for 30-50 minutes. Sieve partially dried granules through
mesh no. 14 of SS screen. Dry again at 55-65 0C until required moisture
content obtained. Observed moisture content…. Collect into the poly bag.

Step 5) Sieve Crospovidone, Croscarmellose Sodium & Anhydrous Dibasic

Calcium Phosphate through 30 mesh & transfer into step-4 and mix for 5
Blending minutes.
Step 6) Sieve Colloidal Silicon Dioxide (Aerosil 200/Cab-O-Sil M5P), &
Magnesium Stearate through 60 mesh & transfer into step-4 and mix for 3
minutes.
Properties of Powder:
Description of Powder: White to off white colored free flowing granules.
Flowability:
Sieve mesh: 20,14, 30, 60
Upper Punch:

Lower Punch:
Compression
Die :

Compress the granules into tablet by using compression machine.

Remarks:

Prepared by: Checked by:

Azizur Rahman Mst. Asma Khatun

Sr. Executive, PD Deputy Manager, PD

Page 3 of 7
 Navana Pharmaceuticals Ltd.
PRODUCT DEVELOPMENT DEPARTMENT
Rupshi,Rupganj, Narayanganj, Bangladesh
LAB BATCH HISTORY- TABLET

Physical Parameters of Core Tablet

Appearance White to off white colored compressed tablet.
Individual Weight

Length

Width

Thickness

Hardness

Friability

Disintegration Time

Moisture Content

Remark:

Formulation for coating: 500 g tablets (with placebo)

Material QC Ref. Name of Materials Spec Qty/Unit Batch Actual Done Checked
Code No. (mg) Qty (g) Qty (g) by by
NKKT0029 Opadry 21K58794 Ph. Gr.

NKKT0007 Methanol BP

NEEX0183 Methylene Chloride BP

Prepared by: Checked by:

Azizur Rahman Mst. Asma Khatun

Sr. Executive, PD Deputy Manager, PD

Coating Procedure:

Page 4 of 7
 Navana Pharmaceuticals Ltd.
PRODUCT DEVELOPMENT DEPARTMENT
Rupshi,Rupganj, Narayanganj, Bangladesh
LAB BATCH HISTORY- TABLET

Step Process Description Done Checked

by by
Coating Solution Preparation:
Step 1) Weigh accurately all the ingredients as per formulation.
Mixing Step 2) Mix Methanol & Methylene Chloride
Step 3) Disperse Opadry 21K58794 in the mixture of Methanol & Methylene
Chloride Stir the solution 20 min continuously.
Coating Machine Name:
Setting Parameters:

Coating Inlet temperature (0C):

Machine Outlet temperature(0C):
Setting
Atomizing pressure (kg/cm2):
Peristaltic pump rate:
Pan rotation :
Initial tablet weight:
Drying Temp:
Drying Time:
Drying Tablet weight after dry:

Surface of tablet:

Hardness:

Initial parameters Final parameters

Inlet temperature (0C): Inlet temperature (0C):

Outlet temperature(0C): Outlet temperature(0C):
Coating
Atomizing Atomizing pressure (kg/cm2):
solution
2
spraying pressure (kg/cm ):
Peristaltic pump rate:
Peristaltic pump rate:
Pan rotation :
Pan rotation :
Total spraying time:

Prepared by: Checked by:

Azizur Rahman Mst. Asma Khatun

Sr. Executive, PD Deputy Manager, PD

Page 5 of 7
 Navana Pharmaceuticals Ltd.
PRODUCT DEVELOPMENT DEPARTMENT
Rupshi,Rupganj, Narayanganj, Bangladesh
LAB BATCH HISTORY- TABLET

Final Drying Inlet temperature (0C):

Outlet temperature(0C):
Pan rotation:
Drying time:
Cooling Inlet temperature (0C):
Outlet temperature(0C):
Pan rotation:
Cooling time:
Weight of tablet after coating:
% of weight gain

=---------------------------------------------------------×100 =--------------------%

Remarks:

Physical Parameters of Coated Tablet

Appearance

Individual Weight

Diameter

Thickness

Hardness

Disintegration Time

Moisture Content

Remarks:

Prepared by: Checked by:

Azizur Rahman Mst. Asma Khatun

Sr. Executive, PD Deputy Manager, PD

Page 6 of 7
 Navana Pharmaceuticals Ltd.
PRODUCT DEVELOPMENT DEPARTMENT
Rupshi,Rupganj, Narayanganj, Bangladesh
LAB BATCH HISTORY- TABLET

Comments on Total Procedure: Sign & date:

Stability Sample Information:

Sample quantity Keeping condition Keeping date

Done By: Checked By:

Prepared by: Checked by: Reviewed by: Approved by:

Azizur Rahman Mst. Asma Khatun Ayesha Zaman Mustafa Khalid Shams
Sr. Executive, PD Deputy Manager, PD Sr. Manager, PD Head of Plant

Page 7 of 7