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ITOPRIDE HYDROCHLORIDE - Reference: In house

S.No.

TEST

SPECIFICATION

01.

Description

A white to off white crystalline powder. 

02. Solubility Soluble in water , Methanol and sparingly soluble in Acetic Acid. 
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 191o C and 195oC
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 titrimetry)
Should be between 98.0% and102.0% w/w.

 
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