Sofosbuvir Impurity 91 (CAS 817204-35-6) é uma impureza relacionada ao processo identificada no perfil de degradação do sofosbuvir; caracteriza-se por modificações na cadeia nucleosídica que podem afetar pureza e estabilidade. A detecção e quantificação exigem técnicas analíticas sensíveis como HPLC acoplado a UV | LC-MS e espectroscopia de RMN para confirmação de massa e estrutura. Controles de processo incluem otimização de condições de reação | etapas de purificação cromatográfica e especificações de liberação baseadas em ICH Q3A/Q3B. Monitoramento contínuo e investigação de vias de formação são essenciais para estabelecer limites aceitáveis e garantir a conformidade regulatória.
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