Alogliptin Impurity 22 | CAS 655-63-0 | es una impureza relacionada del proceso que requiere identificación y cuantificación precisa en el perfil de calidad. Químicamente tiene relevancia por su potencial formación por degradación térmica o por reacciones secundarias durante la síntesis | y su presencia puede influir en la pureza final del lote. El control analítico se realiza típicamente por HPLC con detectores UV o MS para límites de cuantificación bajos | y la caracterización incluye espectroscopía y estudios de estabilidad forzados. Establecer límites | vías de formación y procedimientos de eliminación es crítico para cumplir especificaciones regulatorias y garantizar seguridad y consistencia del producto.
Referencias
Kaku, Kohei, et al. “Benefit-Risk Assessment of Alogliptin for the Treatment of Type 2 Diabetes Mellitus.†Drug Safety, vol. 42, no. 11, 25 Oct. 2019, pp. 1311–1327, 10.1007/s40264-019-00857-8. Accessed 1 May 2020.
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