Brivaracetam Impurity 1 (CAS 112106-16-8) es un derivado éster del ácido butanodioico asociado al proceso sintético de brivaracetam. Esta impureza químicamente definida puede formarse por esterificación lateral y racemización parcial y presenta propiedades fisicoquímicas que requieren control riguroso durante la síntesis y el purificado. Su identificación y cuantificación se realiza mediante HPLC con detección UV y confirmación por espectrometría de masas y RMN. La presencia de esta impureza afecta la pureza del principio activo y puede influir en la estabilidad del lote por lo que los límites de aceptación y las estrategias de eliminación por cromatografía y optimización de condiciones de reacción son críticos para el cumplimiento de especificaciones.
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