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Product name: Itraconazole
CAS:84625-61-6
MF:C35H38Cl2N8O4
Appearance:White powder
Application:Antibiotic and Antimicrobial Agents
tems | Specifications | Results |
Appearance | White or almost white powder | Almost white powder |
Identification | IR conforms to standard(2.2.24) | Complies |
Appearance of solution | Solution S is clear(2.2.1) and not more intensely colored than reference solution R6 or B6(2.2.2, Method II) | Complies |
Related substances | (2.2.29) |
|
Impurities B | Not more than 0.3% | Not detected |
Impurities G | Not more than 0.3% | 0.1% |
Impurity E | Not more than 0.2% | Not detected |
Sum of impurities C and D | Not more than 0.3% | Not detected |
Unspecified impurities | Not more than 0.10% | 0.06% |
Total impurities | Not more than 0.8% | 0.3% |
Loss on drying | Not more than 0.5%(2.2.32) | 0.1% |
Sulfated ash | Not more than 0.10%(2.4.14) | 0.03% |
Assay | 99.0% to 101.0%(%(2.2.20) |