Name: Clopidogrel bisulfate
Formula: C16H18ClNO6S2
Molecular Weight: 419.90
Clopidogrel is an oral, thienopyridine class antiplatelet agent used to inhibit blood clots in coronary artery disease, peripheral vascular disease, and cerebrovascular disease. The drug works by irreversibly inhibiting a receptor called P2Y12, an adenosine diphosphate ADP chemoreceptor.
Specification:
Testing Items | Specifications | Results |
Appearance | White to off-white powder | White powder |
Solubility | Freely soluble in methanol, every slightly soluble
in acetone, chloroform, water and practically insoluble in anther |
Complies |
Identification | IR: As stipulated | Complies |
HPLC: As stipulated | Complies | |
It responds to the test for sulfate | Complies | |
Specific rotation | +52.0~+56 | +54.1 |
Loss on drying | <0.5% | 0.19% |
Residue on igtation | <0.1 | 0.03% |
Related substances | Related compound <0.2% | 0.08% |
Related compound <0.3% | 0.08% | |
Any other individual impurity<0.1% | 0.05% | |
Total impurities<0.1% | 0.25% | |
Isomer | <0.1% | 0.20% |
Assay(on dry basis) | 98.5~101.5% | 99.9% |
Residual solvents | Methanol<3000ppm | 15.4ppm |
Acetone<5000ppm | Undetected | |
Acetonitrile<410ppm | Undetected | |
Dichloromethane <600ppm | Undetected | |
Ethyl acetate<5000ppm | 127.6ppm |
Packaging details:
Packaging details: | 25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
Storage: | Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
Shelf Life: | 5 years if sealed and store away from direct sun light. |
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