Bicalutamida EP Impurity H (CAS 2512198-58-0) | sinônimos: 3-hydroxy-2-methylpropanamide; N-(4-Cyano-3-(trifluoromethyl)phenyl)-2-((4-fluorophenyl)sulfonyl) | é uma impureza processual crítica cuja presença pode afetar a pureza do princípio ativo; suas funções organofuncionais ciano | trifluorometil e sulfonil indicam elevada estabilidade e absorvância em UV | favorecendo detecção por HPLC-UV | LC-MS e caracterização por RMN para confirmação estrutural. Recomenda-se controle por limites de relatório e qualificação conforme ICH Q3A | padrões de referência para validação analítica e investigação de vias de formação durante etapas de síntese e purificação para minimizar riscos à qualidade do medicamento.
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