Mizolastine Impurity 3 (sal de acetato) | CAS 123018-79-1 | es una impureza relacionada que puede formarse durante etapas de síntesis | purificación o conversión a sal. Su caracterización requiere técnicas analíticas como HPLC con detección UV | LC-MS para identificación de masa y NMR para confirmación estructural | además de pruebas de contenido de agua y actividad óptica cuando proceda. La presencia de esta impureza puede afectar estabilidad | perfil de seguridad y rendimiento farmacológico del ingrediente activo | por lo que se recomienda establecer límites de especificación basados en ICH Q3A/Q3B | un estándar de referencia y una estrategia de control que incluya eliminación en procesos de purificación y monitorización rutinaria.
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