Alogliptin Impurity 18 (CAS 1430222-09-5) es una impureza orgánica relevante en el perfil de impurezas de alogliptina | caracterizada por su masa molecular y espectros IR | NMR y MS específicos. Su identificación y cuantificación mediante HPLC con detección UV y LC-MS/MS permiten evaluar su nivel en lotes y procesos de síntesis. Estudios de estabilidad y degradación han definido condiciones que favorecen su formación | informando controles de proceso y parámetros de purificación. La caracterización completa soporta límites de aceptación y métodos de liberación | facilitando cumplimiento regulatorio y reducción del riesgo en control analítico del producto intermedio.
Referencias
Cada, Dennis J., et al. “Alogliptin.†Hospital Pharmacy, vol. 48, no. 7, 2013, pp. 580–592, www.ncbi.nlm.nih.gov/pmc/articles/PMC3839527/, 10.1310/hpj4807-580. Accessed 4 Nov. 2021.
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