Maribavir Impurity 2 (CAS 193526-90-8) es una impureza relacionada estructuralmente con Maribavir identificada en etapas de síntesis y almacenamiento. Su caracterización se realiza mediante HPLC de alta resolución, LC-MS para la confirmación de masa y RMN para la elucidación estructural, permitiendo establecer perfiles de degradación y vías de formación. La presencia de esta impureza puede afectar la pureza farmacéutica y la estabilidad del lote; por ello se establecen límites analíticos y criterios de aceptación basados en toxicidad y regulación. Se recomienda implementar controles de proceso, muestreo dirigido y estándares de referencia para cuantificación y eliminación eficaz durante el desarrollo y control de calidad.
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