Donepezil Impurity 28 (HCl) | CAS 608511-39-3 | é uma impureza relacionada ao processo sintético de Donepezil caracterizada como sal cloridrato; exige monitoramento rigoroso no perfil de impurezas por afetar pureza | estabilidade e conformidade com especificações. A detecção e quantificação são realizadas por cromatografia líquida de alta eficiência com detecção UV e confirmação por espectrometria de massa; como parte do controle de qualidade | a validação do método deve abranger seletividade | linearidade | limite de detecção e quantificação e robustez. Estudos degradacionais e avaliação de risco toxicológico suportam especificações de aceitação e controles de processo para minimizar formação durante síntese e purificação.
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