Impureza Sofosbuvir 3′ | 5′-Bis-(S)-phosphate (CAS 1337482-17-3) é um contaminante gerado durante etapas de fosforilação na síntese do pró-fármaco | com impacto direto no perfil de impurezas e na pureza final do lote. A presença desta entidade química exige monitorização por HPLC com detecção UV e confirmação por espectrometria de massa e RMN para caracterização estrutural e quantificação. Estudos de estabilidade demonstram potencial formação por degradação hidrolítica | exigindo condições de processo e purificação otimizadas para minimizar níveis residuais. Dados analíticos robustos e limites de especificação são essenciais para cumprimento regulatório e garantia de qualidade farmacêutica.
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