Clopidogrel hydrogen sulfate/135046-48-9
Melting point 184oC
Boiling point 447.3oC at 760 mmHg
Flash point 224.3oC
| Itemsoftesting | Specifications | Results |
| Characters | Whitetooff-whitepowder | Whitepowder |
| Assay | 98.5%~101.5% | 99.8% |
| Solubility | Freelysolubleinmethanol， everyslightlysolubleinacetone，chloroform，waterandpracticallyinsolubleinaether | Complies |
| Identification | IR:Asstipulated HPLC:Asstipulated Itrespondstothetestforsulfate | Complies Complies Complies |
| Lossondrying | ≤0.5% | 0.21% |
| Residueonigtation | ≤0.1% | 0.03% |
| Relatedsubstances | RelatedcompoundA≤0.2% | 0.07% |
| RelatedcompoundB≤0.3% | 0.07% | |
| Anyotherindividualimpurity≤0.1% | 0.05% | |
| Totalimpurities≤1.5% | 0.24% | |
| Isomer | ≤1.0% | 0.20% |
| Residualsolvents | Dichloromethane≤300ppm | 39.5ppm |
| Ethylacetate≤2000ppm | Undetected | |
| 4-Mehyl-2-Pentanone≤4000ppm | 1740.7ppm | |
| Conclusion | ComplieswithUSP31 | |