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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 A≤0.2% |
0.08% |
|
Related compound B≤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. |
