LEON PHARMACEUTICALS LIMITED

Satkhamair, Sreepur, Gazipur.

Department Quality Control

Title Test Report Of Raw Material Active
Form No. Version Effective Date Page
QC/FORM/RM/LAI003 02 01-10-2013 01 of 01

Prepared By Checked By Approved By

________________ ___________________ ____________________
QC Officer Asst. Manager, QC Deputy Manager, QA

MATERIAL NAME : Amlodipine besilate

Definition : 3-Ethyl 5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-
1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate.
Molecular Formula : C20H25ClN2O5,C6H6O3S Molecular Weight : 567.1
Material Code : LAI003 Batch Number :
R Number : MRN Number :
No. of Container(s) : Sampling Ref. No. :
Supplier : QC Reference No. :
Manufacturer : Quantity :

Parameter Specification Result Remarks

Characters Appearance : White or almost white powder.
Solubility : Slightly soluble in water, freely soluble in methanol,
sparingly soluble in ethanol, slightly soluble in 2-
pronol.
Identification : Must comply with the Identification test of BP-2012,
Page-142.
Optical Rotation : Must comply with the test of BP-2012, Page-142.
Related Substances : Must comply with the test of BP-2012, Page-142.
Water : Maximum 0.5%, determined on 3.000 g.

Assay As is :
OAB : 97.0 % to 101.0% of Amlodipine Besilate.
Storage Condition : In an airtight container, protected from light.
Container Type : Plastic or paper drum with polyethylene bag.
Certificate of Analysis : The manufacturer should supplied certificate of
analysis for every batch.

Comments: Tested on:

Test Performed By Test Checked By Test Approved By

________________ ___________________ ____________________

QC Officer Asst. Manager, QC Deputy Manager, QA