Trazodone EP Impurity A (HCl Salt) (CAS 55290-66-9) | también conocida como Trazodone N-Oxide (HCl Salt) o 4-(3-clorofenil)-1-(3-{3-oxo-2H | 3H-[1 | 2 | 4]triazolo[4 | 3-a]piridin-2-yl}propil)piperazin-1-ium-1-olate hydrochloride | es una impureza N-óxido derivada de la piperazina que puede formarse por oxidación durante la síntesis o el almacenamiento; presenta alteraciones en polaridad y masa detectable por HPLC | MS y RMN. Su identificación y cuantificación son esenciales para el control del perfil de impurezas; se recomiendan límites analíticos definidos | métodos validados y estrategias de control como condiciones redox controladas y el uso de agentes antioxidantes para minimizar su presencia y garantizar la conformidad con especificaciones.
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