Roxadustat Impurity 11 (CAS 1421312-34-6) es una impureza relacionada con el proceso observada en etapas de síntesis y purificación del principio activo. Desde un punto de vista analítico requiere monitorización precisa mediante HPLC con detección UV, LC-MS para confirmación de masa y RMN para elucidación estructural. Su presencia puede afectar la impureza total y el perfil de seguridad, por lo que se define una estrategia de control que incluye límites basados en ICH Q3A y estudios de degradación forzada. Se recomienda validar métodos analíticos específicos, optimizar pasos de purificación y realizar estudios de estabilidad para garantizar cumplimiento de especificaciones y minimizar riesgos durante el desarrollo y fabricación.
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