SPL Set ID: 68121a71-5024-4f9e-bd9c-2d412f6a6355
1 drug(s) with this SPL Set ID
Abiraterone acetate, the active ingredient of abiraterone acetate tablets is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl)-androsta-5,16-dien-3-ol acetate and its structure is: Abiraterone acetate is a white to off-white powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 500 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. FDA approved dissolution test specifications differ from USP. Structure