Clopidogrel Bisulfate Form - I and Form - II

Anti Coagulant, Anti Platelet agent

Parameters Results
Name Clopidogrel Bisulfate
Quality USP
IUPAC Name (+)-(S)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate
Molecular Formula C16H18ClNO6S2
Molecular Weight 419.8943 gm/mol
CAS Number 120202-66-6
Physical Appearance A white to off-white powder
Solubility Freely soluble in water and in Methanol, practically insoluble in ether
Identification by IR Absorption

A. IR absorption spectrum must be identical with Copidogrel Bisulfate working standard.

B. The retention time of the major peak in the chromatogram of the assay preparation corresponds to that of the standard preparation

C. It must give the reaction of sulfate

Relative Impurities
Impurity A
Impurity B
Impurity C
Any othe Impurity
Total Impurity

Not more than 0.2%
Not more than 0.3%
Not more than 1.0%
Not more than 0.1%
Not more than 1.5%
Water (by K.F.) Not more than 0.5% w/w
Sulphated Ash Not more than 0.1% w/w
Assay (on dry basis) 97% to 101.5% as C16H15ClNO2S. H2SO4 on dried basis