Sofosbuvir Impurity 9 (CAS 863329-65-1) es una impureza relacionada con el proceso de síntesis de sofosbuvir | identificada y caracterizada mediante técnicas analíticas avanzadas como HPLC | LC-MS y RMN. Su control es crítico en desarrollo y producción por su influencia potencial en la estabilidad | perfil de degradación y cumplimiento de especificaciones del principio activo. La caracterización estructural y la cuantificación permiten definir límites de aceptación y medidas de mitigación de acuerdo con guías regulatorias ICH. Se dispone de estándares de referencia y métodos analíticos validados para garantizar una detección sensible | trazabilidad y robustez en programas de control de calidad.
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