Sofosbuvir IP Impurity A (CAS 1190308-01-0) | também conhecida como Sofosbuvir (R)-Phosphate ou Sofosbuvir Rp-Isomer | é uma impureza relacionada que surge por epimerização ou alterações no grupo fosfato durante síntese e acondicionamento. Requer monitoramento analítico rigoroso por HPLC | LC-MS e RMN para identificação estruturada e quantificação em lotes de produção. A sua detecção influencia limites de pureza | otimização de etapas de purificação e critérios de aceitação em controle de qualidade. Dados analíticos fornecidos incluem espectros de massa precisa | deslocamentos de RMN e tempo de retenção para suporte à validação de métodos e conformidade regulatória.
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