Apalutamide

Apalutamide Impurities

Apalutamide impurities include synthetic intermediates, process-related compounds, degradation products, and residual solvents that may arise during synthesis, formulation, or storage. As a nonsteroidal androgen receptor inhibitor used in the treatment of non-metastatic castration-resistant prostate cancer, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. Known degradation pathways include hydrolysis and oxidative transformation, particularly affecting the thiohydantoin and nitrile moieties. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Apalutamide EP Impurities

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

Apalutamide Related Compounds

Structurally related compounds and synthetic analogs associated with Apalutamide are included for use in impurity identification, toxicological qualification, and regulatory submission. These materials are thoroughly characterized and conform to international standards. Related compounds are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations.

Apalutamide Impurity Reference Standards

Apalutamide 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.