1 Sofosbuvir Chloro Analog / Desfluoro Chloro Sofosbuvir
Descripción
Sofosbuvir IP Impurity B (CAS 1496552-51-2) | conocido también como análogo cloro de Sofosbuvir o desfluoro cloro Sofosbuvir | es una impureza relacionada que deriva de la sustitución cloro en la posición desfluorada del nucleósido. Su presencia puede afectar perfiles de pureza | estabilidad y seguridad del lote | por lo que requiere identificación y cuantificación robusta. Suele detectarse como impureza de proceso mediante HPLC y LC-MS y se caracteriza por NMR y espectrometría de masas. Las estrategias de control incluyen condiciones de síntesis optimizadas | etapas de purificación específicas y límites de aceptación definidos por el análisis de riesgo y guías regulatorias para APIs.
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