A Impureza EP D da Bicalutamida, CAS 654-70-6, corresponde a 4-Amino-2-(trifluorometil)benzonitrila, também descrita como 5-Amino-2-cianobenzotrifluoreto ou 4-ciano-3-(trifluorometil)anilina. Este anilino-nitrilo aromático, de fórmula C8H5F3N2 e massa molecular 186,13 g/mol, é uma impureza de processo estruturalmente definida associada à síntese da bicalutamida e ao manuseio de intermediários, e não predominantemente um produto de degradação. A sua presença é normalmente controlada em níveis baixos devido à avaliação toxicológica de derivados de anilina no âmbito do ICH M7 quando o destino residual não está adequadamente caracterizado. A determinação exige, em geral, LC-MS/MS, LC-HRMS ou GC-MS com derivatização apropriada e separação cromatográfica de isômeros fluoro e trifluorometil estreitamente relacionados.
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