Clopidogrel bisulfate (120202-66-6)

Items Specification Results Characteristics A white or almost white powder A almost white powder Identification 1)The IR absorption spectrum of sample responds to that of USP clopidogrel bisulfate CRS conforms 2)The RT of the major peak in the chromatogram of the sample corresponds to that of the reference standard conforms 3) Positive reaction for sulfate conforms Loss on drying ≤0.5% 0.25% Residue on ignition ≤0.1% 0.04% Related substances Impurity A ≤0.2% 0.03% Impurity B ≤0.3% 0.09% Impurity C ≤1.0% ND Individual impurity(unknow) ≤0.1% 0.03% Total impurities 0.15% Assay 97.0 101.5%(dried basis) 99.2% Conclusion The product tested complies with the specification remarks Type I crystalline