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/LAI002 02 01-10-2013 01 of 01

Prepared By Checked By Approved By

________________ ___________________ ____________________

QC Officer Asst. Manager, QC Deputy Manager, QA

MATERIAL NAME : Ambroxol hydrochloride

Definition : trans-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride.
Molecular Formula : C13H18Br2N2O,HCl Molecular Weight : 414.6
Material Code : LAI002 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 yellowish crystalline powder.
Solubility : Sparingly soluble in water, soluble in methanol,
practically insoluble in methylene chloride.
Identification : Must comply with the Identification test of BP-2007,
Page-113.
Appearance of solution : 5% solution in methanol is clear and not more intensely
coloured than reference solution Y6.
pH : The pH of 1.0% solution is 4.5 to 6.0.
Related Substances : Must comply with the test of BP-2012, Page-121.
Heavy Metals : Maximum 20 ppm (test as per BP-2012, Page-121.).
Loss on drying : Maximum 0.5%, determined on 1.000 g at 1000C - 1050C.
Assay As is :
ODB : 99.0 % to 101.0% of Ambroxol Hydrochloride.
Storage Condition : Store 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