Synthesis and Characterization of API‐Related Substances in Abiraterone Acetate**

Abstract

AbstractAbiraterone acetate (Zytiga®) is known as an anticancer medication that inhibits an enzyme called cytochrome P450 (CYP17) responsible for androgen production. The monographs of United States Pharmacopeia (USP) reported the list of eleven process‐related impurities for its active pharmaceutical ingredient (API). This article pertains to the identification and synthesis of eight process‐related impurities that were detected during the process development of Abiraterone acetate. The detection and identification of these impurities were accomplished using HPLC and LCMS. Further, the structures of these impurities were confirmed by synthesizing them in moderate to excellent yield and characterized by various orthogonal techniques.