LEON PHARMACEUTICALS LIMITED

Satkhamair, Sreepur, Gazipur.

Department Quality Control

Title Test Report Of Finished Product
Form No. Version Effective Date Page
QC/FORM/TR/FP/DCT003 02 01-01-2014 01 of 01

Prepared By Checked By Approved By

____________________ ____________________ ____________________
Asst. Manager, QC Asst. Manager, QC Deputy Manager, QA

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