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:
| TestingItems | Specifications | Results |
| Appearance | Whitetooff-whitepowder | Whitepowder |
| Solubility | Freelysolubleinmethanol,everyslightlysoluble
inacetone,chloroform,waterandpracticallyinsolubleinanther | Complies |
| Identification | IR:Asstipulated | Complies |
| HPLC:Asstipulated | Complies | |
| Itrespondstothetestforsulfate | Complies | |
| Specificrotation | +52.0~+56 | +54.1 |
| Lossondrying | <0.5% | 0.19% |
| Residueonigtation | <0.1 | 0.03% |
| Relatedsubstances | Relatedcompound <0.2% | 0.08% |
| Relatedcompound <0.3% | 0.08% | |
| Anyotherindividualimpurity<0.1% | 0.05% | |
| Totalimpurities<0.1% | 0.25% | |
| Isomer | <0.1% | 0.20% |
| Assay(ondrybasis) | 98.5~101.5% | 99.9% |
| Residualsolvents | Methanol<3000ppm | 15.4ppm |
| Acetone<5000ppm | Undetected | |
| Acetonitrile<410ppm | Undetected | |
| Dichloromethane <600ppm | Undetected | |
| Ethylacetate<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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