Bicalutamide EP Impurity D, CAS 654-70-6, is 4-Amino-2-(trifluoromethyl)benzonitrile, also described as 5-Amino-2-cyanobenzotrifluoride or 4-cyano-3-(trifluoromethyl)aniline. This aromatic aniline-nitrile, formula C8H5F3N2 and molecular weight 186.13 g/mol, represents a structurally defined process-related impurity associated with Bicalutamide synthesis and related intermediate handling rather than a degradant class. Its presence is typically controlled at low levels because aniline derivatives may raise toxicological scrutiny under ICH M7 when residual fate is insufficiently characterized. Determination generally requires selective LC-MS/MS, LC-HRMS, or GC-MS after appropriate derivatization, with chromatographic separation from closely related fluoro-trifluoromethyl isomers.
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