Maribavir Impurity 9 (CAS 176161-55-0) es una impureza relevante en el perfil de calidad del principio activo que requiere caracterización y control estrictos. Su identificación y cuantificación se realizan mediante HPLC con detección UV y LC-MS para confirmación de masa, acompañadas de espectroscopía NMR para elucidación estructural. Se evalúan estabilidad, solubilidad y puntos de retención para definir límites de especificación y criterios de aceptación en liberación de lote. Las metodologías validadas permiten monitorear formación durante síntesis y almacenamiento, facilitando estrategias de mitigación como optimización de procesos y purificación. Documentación analítica y trazabilidad son clave para cumplimiento regulatorio.
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