Hydroxy Donepezil (CAS 197010-20-1) | também referido como Donepezil EP Impurity C ou Donepezil Hydroxy Keto Impurity | é uma impureza do processo associada à oxidação e à formação de cetona/hidroxila durante a síntese de donepezil. A presença desta impureza exige monitoramento rigoroso em controle de qualidade por meio de técnicas analíticas validadas | incluindo HPLC com detecção UV | LC-MS para identificação de massa e RMN para confirmação estrutural. Especificações e limites aceitáveis devem ser estabelecidos conforme guias regulatórios para garantir perfil de pureza | estabilidade e segurança do lote. Estratégias de mitigação incluem otimização de etapas sintéticas | purificação reforçada e uso de padrões de referência.
Referências
Krishna Reddy, K. V. S. R., et al. “Identification and Characterization of Potential Impurities of Donepezil.” Journal of Pharmaceutical and Biomedical Analysis, vol. 35, no. 5, Sept. 2004, pp. 1047–58, https://doi.org/10.1016/j.jpba.2004.03.022.
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