Diclofenac 2 | 5-Quinone Imine (CAS 1254576-93-6) é uma impureza quinona imina associada ao metabolismo oxidativo do diclofenaco | também referida como 5-hydroxydiclofenac quinone imine ou 5-hydroxy diclofenac benzoquinone. Trata-se de um eletrofílico reativo formado por oxidação enzimática ou degradação química | com potencial para formar adutos proteicos e influenciar perfil de segurança do fármaco. A sua detecção e quantificação exigem técnicas analíticas sensíveis como LC-MS/MS | HPLC com detecção UV e espectroscopia NMR para confirmação estrutural. Controle de processo | condições de armazenamento e testes de estabilidade são essenciais para limitar níveis e garantir conformidade com diretrizes de qualidade e qualificação de impurezas.
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