La impureza Metoxi de Sofosbuvir (CAS 1394157-34-6) es un producto relacionado que puede formarse durante la síntesis o el almacenamiento del principio activo y exige control analítico riguroso. Su identificación y cuantificación se realizan mediante HPLC con detección UV y confirmación por LC-MS y RMN para caracterizar fragmentos y desplazamientos químicos. Estudios de estabilidad y perfiles de degradación permiten definir límites críticos y especificaciones de aceptación para garantizar la calidad del lote. Las estrategias de mitigación incluyen optimización de pasos sintéticos | purificación cromatográfica y condiciones de formulación que minimicen su formación. La documentación debe incluir metodología validada | criterios de aceptación y evaluación toxicológica cuando proceda.
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