Abiraterone

Abiraterone Impurities

Abiraterone impurities consist of structurally related analogs, residual solvents, and degradation products formed under stress conditions such as hydrolysis, oxidation, and photolysis. As a steroidal CYP17 inhibitor used in the treatment of metastatic castration-resistant prostate cancer, impurity profiling is essential to maintain therapeutic efficacy and patient safety. Degradation pathways typically involve hydrolytic cleavage of the acetate ester and oxidative modifications of the steroidal backbone. All impurities are structurally characterized and qualified in accordance with ICH guidelines for toxicological assessment and analytical validation.

Abiraterone EP Impurities

Pharmacopeial and non-pharmacopeial Abiraterone impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and long-term stability studies. EP traceable materials are supplied with validated analytical data, including purity, structural confirmation, and spectral characterization.

Abiraterone Related Compounds

Structurally related compounds and synthetic analogs associated with Abiraterone are included for use in impurity identification, toxicological qualification, and regulatory submission. These related substances are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations. They are essential for understanding the impurity profile and ensuring compliance with regulatory limits.

Abiraterone Impurity Reference Standards

Abiraterone impurity reference standards are provided with validated analytical data, including purity, NMR, MS, and full Certificates of Analysis. These standards are used in pharmaceutical research, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request and are routinely re-tested to ensure consistency and reliability.