Maribavir Impurity 10 (CAS 142356-40-9) es una impureza relacionada que requiere control riguroso dentro del perfil de calidad del principio activo, caracterizada y confirmada por técnicas analíticas avanzadas como HPLC y LC-MS, con soporte estructural mediante RMN cuando procede. Su presencia puede afectar pureza, estabilidad y cumplimiento de especificaciones, por lo que se define una estrategia de control basada en límites aceptables, estudios de degradación forzada y muestreo en lote. Se recomienda monitoreo continuo en desarrollo y producción, criterios de aceptación claros para liberación y documentación adecuada para auditorías regulatorias conforme a guías ICH.
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