La impureza Escitalopram Butyryl (CAS 1803244-58-7) es un impuro relacionado identificado durante la síntesis y el control de calidad del API de escitalopram. Presenta consideraciones críticas para el perfil de seguridad y la especificación farmacéutica por su posible contribución a impurezas relacionadas y a variaciones en la actividad. Se detecta y cuantifica mediante LC-MS y HPLC con detección UV, aplicando límites de aceptación basados en ICH Q3A/B. Estudios de estabilidad forzada permiten evaluar su formación bajo condiciones de humedad, temperatura y pH. Su caracterización por espectroscopía NMR y HRMS facilita la confirmación estructural y la implementación de medidas de proceso para minimizar su presencia.
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