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Certificate of Analysis Version No.:01

Material Name Cefuroxime Axetil USP Material Code 1103004
Prepared by: QC Officer Checked by: Asst. Manager, QC Approved by: QA Manager
Sign & Date Sign & Date Sign & Date

Analytical Method TP/1103004/01 Specification SPEC/A/1103004/01

Code
GRN Number RMI/073 Receiving date 07.11.13
Manufacturer Name Covalant Lab. Pvt. Ltd Origin India
Mfgs Lot No./Batch No. CAAN130435 Suppliers Name Covalant Lab. Pvt. Ltd
Mfg. date Sept-2013 QC ref. No. QC/RM/13/328
Exp. date Aug-2016 Total Quantity 70.0 Kg
Tests Specifications Specification Results
s (Veritas )
01 Appearance White to almost white powder. Same white powder
02 Solubility The amorphous form is freely soluble in Same Complies
Acetone, 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 Same Complies
with that of standard.
04 Crystallinity Meets the requirement Same Complies
05 Water content, % Not More Than 1.5% Same 0.98%
06 Diastereoisomer ratio 0.48 and 0.55 Same 0.52
07 Assay (anhydrous basis), 745.0 ~ 875.0 Same 813.4 g/mg
g/mg
Note: Individual analysis for Appearance & Identification, all other tests are to be done with composite sample.
*Complies as per manufacturer Certificate of analysis.
Data compiled by: : Checked by :

Date
Remarks : CONFORM
Lot/Batch: Released
Form No. : VPL-QC-013-08/01
: Date :
DOES NOT CONFORM to the requirements of the specifications
Rejected
_____________________
Sign of QC Authorized person &
date