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/LAI001 02 01-10-2013 01 of 01

Prepared By Checked By Approved By

________________ ___________________ ____________________

QC Officer Asst. Manager, QC Deputy Manager, QA

MATERIAL NAME : Aceclofenac

Definition : [[[2-[(2,6-Dichlorophenyl)amino]phenyl]acetyl]oxy]acetic acid.
Molecular Formula : C16H13Cl2NO4 Molecular Weight : 354.2
Material Code : LAI001 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 crystalline powder.
Solubility : Practically insoluble in water, freely soluble in
acetone, soluble in alcohol.
Identification : Must comply with the Identification test of BP-2012,
Page-46.
Related Substances : Must comply with the test of BP-2012, Page-46.
Heavy Metals : Maximum 10 ppm (test as per BP-2012, Page-46.
Loss on drying : Maximum 0.5%, determined on 1.000 g at 1000C to
1050C.

Assay As is :
ODB : 99.0 % to 101.0% of Aceclofenac.
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