Impureza Trazodone BP Impurity G es una impureza relacionada estructuralmente con la trazodona | identificada como derivado isobutil éter (Trazodone Isobutyl Ether Impurity). Se caracteriza por un perfil cromatográfico y espectrométrico definido | detectada por HPLC y LC-MS durante el control de calidad y estudios de degradación. Su monitoreo contempla límites de aceptación conforme a guías ICH | evaluación de riesgo toxicológico y establecimiento de especificaciones analíticas validadas. La documentación incluye procedimientos de muestreo | condiciones de cromatografía | factores de retención y estrategias de reducción en la etapa de síntesis para mitigar su formación en el proceso de fabricación.
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