Cyproterone Acetate

Cyproterone Acetate Impurities

Cyproterone Acetate is a steroidal antiandrogen with progestational activity, widely used in the treatment of prostate cancer, severe acne, and certain hormonal disorders. Its impurity profile includes structurally related analogs, residual solvents, and degradation products formed under stress conditions such as hydrolysis, oxidation, and photolysis. Degradation pathways typically involve hydrolytic cleavage of the acetate ester, oxidation of the steroid nucleus, and rearrangement of the ketone moieties. These impurities may affect the drug’s potency, stability, and safety. All impurities are structurally characterized and qualified in accordance with ICH guidelines for toxicological assessment and analytical validation.

Cyproterone Acetate EP Impurities

Pharmacopeial and non-pharmacopeial Cyproterone Acetate 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.

Cyproterone Acetate Related Compounds

Structurally related compounds and synthetic analogs associated with Cyproterone Acetate 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.

Cyproterone Acetate Impurity Reference Standards

Cyproterone Acetate 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.