Clopidogrel Bisulfate Api Cas No: 120202-66-6

Specifications :-

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 other 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