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RACECADOTRIL - Reference: In house

S.No.

TEST

SPECIFICATION

01.

Description

A white crystalline powder. 

02. Solubility Soluble in Methanol and Chloroform 
03 Identification
a) IR


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

04.

Melting Range Between 75o C and 77o
05.  Loss of Drying Not more than 0.5% w/w
06. Sulphated Ash Not more than 0.2% w/w 
07. Heavy Metals Not more than 0.002 % w/w 
08. Chromatographic purity
By HPLC 
Maximum single Impurity : Not more than 0.5%
Total Impurities : Not more than 1.0%
09. Assay on Dried Basis
(by HPLC)
Should be between 98.0 and 102.0% w/w

 
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