Customization: | Available |
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CAS No.: | 366789-02-8 |
Shelf Life: | 3 Years |
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Rivaroxaban
1. Rivaroxaban is used for adult patients undergoing elective hip or knee replacement surgery to prevent venous thrombosis (VTE).
2. Rivaroxaban is used to treat adult venous thrombosis (DVT) and reduce the risk of DVT recurrence and pulmonary embolism (PE) after acute DVT.
3. Rivaroxaban is used for adult patients with nonvalvular atrial fibrillation who have one or more risk factors (such as congestive heart failure, hypertension, age ≥ 75 years, diabetes, stroke or transient ischemic attack history) to reduce the risk of stroke and systemic embolism.
Test Items |
Specification |
Results |
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Appearance |
White or yellowish powder |
White powder |
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Solubility |
Practically insoluble in water,freely soluble in DMSO, Practically insoluble in anhydrous ethanol and in heptanes |
Conforms |
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Identification
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IR spectrum should comply with the WS. |
Conforms |
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HPLC-RT of sample under Enantiometric purity test should comply with that of WS. |
Conform |
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Sulphate ash |
Not more than 0.1% |
0.0% |
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Water |
Not more than 0.50% |
0.21% |
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Loss on drying |
Not more than 0.50% |
0.30% |
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Heavy metal |
Not more than 20ppm |
Less than 20ppm |
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Enantiomeric purity |
Impurity A:not more than 0.4% |
N.D |
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Related substance |
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High molecular protein |
NMT 0.5% |
N.D |
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Residual solvent |
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Assay |
98.0-102.0% |
99.9% |