Zeon-Health Industries

Website : http://www.zeonhealth.com Email : info@zeonhealth.com, zeonhealth@hotmail.com

Add: 101, Sai Siddhi Bldg., Sector-3 H, Near Airoli Bus Depot, Airoli, Navi Mumbai – 400708, India

CERTIFICATE OF ANALYSIS
Product Name : FAMOTIDINE USP Mfg. Date : June 2011
Batch No. : 11/FMD/061 Expiry Date : May. 2016

TESTS SPECIFICATION RESULT

White to pale yellowish crystalline
Description White crystalline powder
powder
Freely soluble in Dimethyl Formamide
and in glacial acetic acid, slightly soluble
in methanol, very slightly soluble in
Solubility Complies the test
water, practically insoluble in acetone, in
alcohol, in ether, in chloroform and in
ethyl acetate.
Identification To test A and B of USP Test A and B complies

Loss On Drying Not more than 0.5%W/W 0.23%

Heavy Metals Not more than 0.001% <0.001%

0.07%
Residue on ignition Not more than 0.1%
Chromatographic Purity
Single Major Imp. 0.3% Maximum Complies
Total Imp. 1.0% Maximum Complies
Organic Volatile
To comply the test as per USP Complies
Impurity
Assay Between 98% to 101%W/W ODB 99.15%
Particle size 100 % pass through 50 micron complies

Remark: The Product conforms/Do not conforms to above specification.

Final Disposition : APPROVED / REJECTED
Prepared by Checked by Approved by
Officer Q.C. Executive Q.C. Head Q. C.