Maribavir Impurity 11 (CAS 176161-56-1) es una impureza referida en el perfil de calidad que requiere monitoreo analítico riguroso. Presenta propiedades fisicoquímicas definidas que permiten su identificación por HPLC con detección UV y confirmación estructural mediante LC-MS y RMN. Su generación se asocia a rutas de síntesis secundarias y degradación térmica o química; por ello, los estudios de estabilidad y el desarrollo de métodos de limpieza son críticos para limitar su presencia. Se describen límites de especificación basados en guías regulatorias y estrategias de control incluyen optimización de reacción, purificación cromatográfica y pruebas de liberación para garantizar cumplimiento del perfil de impurezas.
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