Impureza Trazodone Dimer 2 es un subproducto dimerizado que aparece durante la síntesis y almacenamiento de trazodona; su presencia puede afectar el perfil de impurezas y la pureza farmacéutica. Su identificación requiere métodos analíticos sensibles como HPLC acoplado a espectrometría de masas y RMN para confirmar la masa y la conectividad. Se recomienda desarrollar métodos indicativos de estabilidad y límites de aceptación basados en riesgos | evaluación toxicológica y guías regulatorias. Las estrategias de control incluyen optimización de condiciones de reacción | etapas de purificación adicionales y monitoreo continuo en procesos de fabricación para minimizar formación y asegurar cumplimiento de especificaciones de calidad.
Referencias
Shin, J. J., & Abdolreza Saadabadi. (2022, July 10). Trazodone. Retrieved October 30, 2022, from Nih.gov website: https://www.ncbi.nlm.nih.gov/books/NBK470560/
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