VERITAS PHARMACEUTICALS LIMITED ,

Muradpur, Vannara, Mouchak, Gazipur, Bangladesh

SPECIFICATION (RAW MATERIAL)

Material Name : Cefuroxime Axetil USP Code No. : 1103004
Document No. : SPEC/A/1103004/01 Version No.: : 01
Superseded Doc. : AC-0412 Issue Date : 05 Nov2013
Reference : USP Review Date : 06 Nov 2016
Reason for Revision : To change the Specification No.
Storage Condition : In an airtight container
Test Procedure Ref. : TP/1103004/01

Tests Specifications VPL Specification

01 Appearance White to almost white powder. Same
02 Solubility The amorphous form is freely soluble in Acetone, Same
soluble in chloroform, in ethyl acetate and in methanol,
slightly soluble in dehydrated alcohol, insoluble in ether
and in water. The crystalline form is freely soluble in
acetone, sparingly soluble in chloroform, in ethyl
acetate and in methanol, slightly soluble in dehydrated
alcohol, insoluble in ether and in water.
03 Identification IR: Sample spectrum should be concordant with that of Same
standard.
04 Crystallinity Meets the requirement Same
05 Water content, % Not More Than 1.5% Same
06 Diastereoisomer ratio 0.48 and 0.55 Same
07 Assay (anhydrous basis), g/mg 745.0 ~ 875.0 Same
Form No.: VPL-QC-013-02/01

Prepared by Checked by Approved by

Sign & Date

Name Md. Mizanur Rahman Md. Tarikul Islam Bossunia Md. Moniruzzaman
Designation QC Officer Asst. Manager, QC QA, Manager