Sofosbuvir Impurity 63 (CAS 1334513-02-8) é uma impureza relacionada observada durante o desenvolvimento e o controle de qualidade do Sofosbuvir | identificada por cromatografia líquida e confirmada por LC-MS e espectroscopia NMR para elucidação estrutural; sua presença pode derivar de etapas de síntese ou de degradação do princípio ativo e exige quantificação por métodos analíticos validados. O perfil técnico inclui determinação de tempo de retenção | massa molecular e respostas espectrais para suporte à identificação | além de avaliação de níveis residuais em produtos intermediários e finais | sendo crítica para conformidade regulatória e gestão de risco toxicológico potencial.
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