Darolutamide

Darolutamide Impurities

Darolutamide is a non-steroidal androgen receptor inhibitor used in the treatment of non-metastatic castration-resistant prostate cancer. 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 oxidative breakdown of the dihydroxybenzamide moiety, hydrolytic cleavage of the amide bonds, and rearrangement of the heteroaryl substituents. 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.

Darolutamide EP Impurities

Pharmacopeial and non-pharmacopeial Darolutamide 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.

Darolutamide Related Compounds

Structurally related compounds and synthetic analogs associated with Darolutamide 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.

Darolutamide Impurity Reference Standards

Darolutamide 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.