Nilutamide

Nilutamide Impurities & Reference Standards

Nilutamide is recognized as an active pharmaceutical ingredient (API) that supports formulation development, process validation, and quality assurance in drug manufacturing. Nilutamide is registered under CAS Number 63612-50-0. The compound carries the molecular formula C12H10F3N3O4, corresponding to a molecular weight of 317.2 g/mol. Nilutamide related substances / impurity reference standards support HPLC method validation, forced degradation studies, and regulatory documentation consistent with ICH, USP, BP, and EP requirements. Nilutamide is available as a certified impurity reference standard with CoA, HPLC chromatograms, and spectroscopic data to support analytical method development and regulatory compliance.