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Home » Active Pharmaceuticals Ingredients » Clopidogrel Bisulfate

Clopidogrel Bisulfate

Product Name Clopidogrel Bisulfate BP/EP/USP
Chemical Name (+)-(S)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate
CAS Number 113665-84-2
Chemical Formula C16H16ClNO2S
Molecular Mass 321.82 g/mol
Therapeutic Category Antiplatelet

Specification of Clopidogrel Bisulfate :

Test Specification
Description White to off-white powder
Solubility Freely soluble in methanol
Identification
a) By IR
b) Identification of RT by HPLC Assay method
c) Sulphates

The IR spectrum of sample should be concordant with that of working standard.
RT of principal peak in the sample Chromatogram should match that of standard Chromatogram.
Should Respond to test for Sulphates
Loss on drying (%, w/w) [ at 105°C for 2 hours] NMT 0.50%
Residue On Ignition NMT 0.10%
Related substances by HPLC Impurity due to enantiometer A : NMT 0.20%
Impurity due to enantiometer B : NMT 0.30%
Impurity due to enantiometer C : NMT 1.00%
Other Impurity : NMT 0.10%
Total Impurity : NMT 1.50%
Assay by HPLC on Dry basis (%w/w) 97.00% - 101.50%

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