Impureza 12 de trazodona (CAS 111-42-2) es un degradado identificado dentro del perfil de impurezas del principio activo. Caracterizada por cromatografía de alta resolución y confirmada por espectrometría de masas y RMN | su presencia se correlaciona con condiciones de almacenamiento inadecuadas y rutas de síntesis secundarias. Su cuantificación por HPLC y límites de especificación son críticos para garantizar conformidad regulatoria. Estudios de estabilidad y forzado ayudan a establecer mecanismos de formación y estrategias de mitigación mediante optimización de procesos y control de materia prima. La monitorización continua y validación de métodos analíticos aseguran detección sensible y trazabilidad en liberación de lotes.
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