Nilotinib Di-N-Oxide é uma impureza oxidativa relacionada ao nilotinib | também conhecida como BEJ-866 | Nilotinib metabolite P36 e pelo nome químico 4-methyl-N-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[1-oxido-4-(1-oxidopyridin-1-ium-3-yl)pyrimidin-1-ium-2-yl]amino]benzamide. Relevante para o perfil de impurezas do princípio ativo | sua formação decorre da oxidação de centros N-heterocíclicos podendo impactar pureza e estabilidade. A identificação e quantificação exigem LC-MS/MS e HPLC com padrões de referência e espectrometria de massas. Estratégias de controle incluem monitoramento em processo e armazenamento | desenvolvimento de métodos analíticos validados e definição de limites com base em avaliação toxicológica e dados de qualificação.
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