This document is a test report from Leon Pharmaceuticals for their finished product DIPICARD-PLUS TABLET. It details the specifications and results of quality control tests performed on a batch of the product including appearance, identification, loss on drying, weight uniformity, diameter, thickness, hardness, leak testing, disintegration time, dissolution, and assay. The batch passed all tests and was approved for release.
This document is a test report from Leon Pharmaceuticals for their finished product DIPICARD-PLUS TABLET. It details the specifications and results of quality control tests performed on a batch of the product including appearance, identification, loss on drying, weight uniformity, diameter, thickness, hardness, leak testing, disintegration time, dissolution, and assay. The batch passed all tests and was approved for release.
This document is a test report from Leon Pharmaceuticals for their finished product DIPICARD-PLUS TABLET. It details the specifications and results of quality control tests performed on a batch of the product including appearance, identification, loss on drying, weight uniformity, diameter, thickness, hardness, leak testing, disintegration time, dissolution, and assay. The batch passed all tests and was approved for release.
This document is a test report from Leon Pharmaceuticals for their finished product DIPICARD-PLUS TABLET. It details the specifications and results of quality control tests performed on a batch of the product including appearance, identification, loss on drying, weight uniformity, diameter, thickness, hardness, leak testing, disintegration time, dissolution, and assay. The batch passed all tests and was approved for release.
PRODUCT NAME : DIPICARD-PLUS TABLET PRODUCT CODE : DCT-003
Generic Name & Strength : Amlodipine 5 mg( As Amlodipine Batch Number : Besilate) \Tablet Atenolol BP 50 mg/Tablet Batch Size : QC Reference No. : Pack Size : Manufacturing Date : Expiry Date :
PARAMETERS SPECIFICATIONS RESULT REMARKS
Appearance : Yellow, round biconvex shaped film coated tablet in 95 mm x 40 mm Alu-PVC blister pack. Identification : Must comply with the test of Amlodipine & Atenolol. Loss on drying : Not more than 3.0 % w/w. Average weight : 180 mg 5 %. Uniformity of weight : Complies with BP 2007 limit. Diameter : 8.0 mm to 8.3 mm. Thickness : 3.60 mm to 3.90 mm. Hardness : Not less than 2.5 kg/cm2. Leak Test : Must be leak proof at 400 mmHg in 4 min.
Disintegration Time : Not more than 30 minutes.
Dissolution : Not less than 75% of the stated amount of a. Amlodipine Besilate & b. Atenolol is dissolved in 45 minutes in 0.1N acetate buffer pH 4.6 Assay : 95.0 % to 105.0 % of the label amount of a. Amlodipine a. b. Atenolol b.
Comments: Tested on:
Test Performed By Test Checked By Test Approved By ____________________ ____________________ ____________________ QC Officer Asst. Manager, QC Deputy Manager, QA