Home » Active Pharmaceuticals Ingredients » 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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