Clopidogrel Bisulphate

CAS number: 135046-48-9

Molecular formula: C16H16ClNO2S.H2O4S

molecular weight: 419.9

Chemical structure:

DescriptionWhite to off-white powderOff-white powder
SolubilityFreely soluble in pH1, Practically insoluble at neutral pH.Complies
a. IR absorptionThe IR Spectrum of Sample concordant with that of working standard   spectrumConforms
b. HPLCThe retention time of the major peak in the chromatogram of Assay   preparation corresponds to that in the chromatogram of the Standard   preparation as obtained in the Assay.Conforms
c. SulfateIt responds to the test for sulfateConforms
Loss on dryingNMT 0.50% w/w
Residue on ignitionNMT 0.10% w/w0.03%w/w
Related Compounds (By HPLC)
Related Compound ANMT 0.20%ND
Related Compound BNMT 0.30%Below limit
Related Compound CNMT 0.5%
Any other ImpurityNMT 0.10%Below limit
Total ImpuritiesNMT 0.50%Below limit
Assay on dried basis (By HPLC )NLT 97.00% and 101.50%