Abiraterone Acetate

Appearance: White or off white powder;
Solubility: This product is easily soluble in dichloromethane; Dissolve in N, N-dimethylformamide or methanol; Slightly soluble in acetonitrile; Almost insoluble or insoluble in water, 0.1mol/L hydrochloric acid solution, and 0.1mol/L sodium hydroxide solution.
Melting point: should be 143~147 ℃
Specific rotation: should be -47 º to -52 º
Moisture content: not exceeding 0.25%;
Burning residue: not exceeding 0.2%;
Heavy metals: not exceeding 20ppm;
Related substances: Single impurities shall not exceed 0.1%; The total impurities shall not exceed 0.5%;
Palladium: not exceeding 10ppm
Content: should be between 98.0% and 102.0% (based on dry product).

Abiraterone acetate (trade name ZYTIGA) is a CYP17 inhibitor that blocks androgen production in testicular, adrenal, and prostate cancer tissues by inhibiting the key enzyme 17 α – hydroxylase/C17,20-lyase involved in androgen synthesis. This drug needs to be used in combination with prednisone and is suitable for treating metastatic castration resistant prostate cancer that has previously received chemotherapy containing docetaxel. The standard dose is 1000mg orally on an empty stomach per day, and patients with liver function impairment need to adjust the dose.