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Compiled By Checked By Approved By
Date and Sign
CERTIFICATE OF ANALYSIS
Product Name Albendazole USP CAS No: 54965-21-8
Batch No: ALB/030313 A.R. No 13/FP/ALB/0303
Date of Manufacture Feb-2013 Date of Analysis 02-02-13
Batch Quantity 165 kg Date of Retest Jan-2016
Sr.
No
Test Results Acceptance Criteria
1. Appearance White to faintly
yellowish powder.
White to faintly yellowish
powder.
2. Solubility Freely soluble in
anhydrous formic acid;
very slightly soluble in
ether and in methylene
chloride; practically
insoluble in alcohol and
in water.
Freely soluble in anhydrous
formic acid; very slightly soluble
in ether and in methylene
chloride; practically insoluble in
alcohol and in water.
3. Identification
Complies By IR Spectrum: The infrared
absorption spectrum of the test
sample exhibits maxima only at
the same wavelengths as that of
the working standard.
4. Related Substances
Individual Impurity
Total Impurity
0.09 %
0.23%
NMT 0.2 %
NMT 0.5 %
5. Residue On Ignition 0.12% NMT 0.2%
6. Assay 99.5% 98.0 to 102.0%
7. Loss on Drying 0.21% NMT 0.5%
Remarks: The values in the results has been obtained from Manufacturer's COA.