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THALIDOMIDE - Reference: USP 25

S.No.

TEST

SPECIFICATION

01.

Description

A white to off white powder. 

02. Solubility 

Soluble in Dimethyl formamide, Dioxane, Pyridine, Sparingly soluble in Acetone, Butyl acetate, Ethanol, Ethyl acetate, Glacial acetic acid, Methanol, water.
*
Test only in Dimethyl formamide and Acetone for regular analysis.

03 Identification 
 IR:


 The Infra Red absorption spectrum of the finely ground sample in KBr dispersion compressed into a disk should exhibit maxima only at the same wavelengths as that of a similar preparation of THALIDOMIDE working standard.

04.

Microbial limits Total Aerobic Microbial Count : NMT : 100 cfu/g
Total Combined molds and Yeasts Count NMT :10cfu/g
Escherichia coli : Should be nil
Salmonella Species : Should be nil
Staphyloccus aureus : Should be nil
Pseudomonas aeruginosa : Should be nil

 
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