Abiraterone acetate is an antiandrogen medication which is used in the treatment of prostate cancer. It is specifically indicated for use in conjunction with castration and prednisone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and in the treatment of metastatic high-risk castration-sensitive prostate cancer (mCSPC).
Specification
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 |
