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Product Name | Abiraterone acetate |
Synonyms | 17-(3-pyridyl)-5,16-androstadien-3beta-acetate;(3)-17-(3-Pyridinyl)androsta-5,16-dien-3-ol Acetate (Ester);Abiraterone Acetate;CB 7630; |
CAS NO. | 154229-18-2 |
MF | C26H33NO2 |
MW | 391.55 |
Appearence | White Powder |
Items | Specifications | Results | ||
Appearance | White or off white crystalline powder | white crystalline powder | ||
Identification | The retention time of the major peak in the chromatogram of the test preparation corresponds to that in the chromatogram of the reference preparation | Complies | ||
Related Substance | Single impurity ≤0.5% Total impurity ≤1.0% | 0.28% 0.32% | ||
Moisture | ≤0.5% | 0.11% | ||
Residue on ignition | ≤0.1% | 0.02% | ||
Heavy metal | ≤10ppm | Complies | ||
Assay (dry basis) | Not less than 99.0% (HPLC) | 99.7% | ||
Conclusion: The product conforms to the In-house standard |
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