Alogliptin Impurity 27 | identificada como Alogliptin 6-Cloro N-Desmetil Impurity (CAS 865758-95-8) | es una impureza relacionada de proceso relevante para el perfil de pureza de alogliptina. Presenta la pérdida del grupo metilo en el nitrógeno y sustitución con cloro en la posición 6 | lo que afecta propiedades fisicoquímicas y comportamiento cromatográfico. Su detección y cuantificación mediante HPLC | LC-MS y RMN es esencial para cumplir especificaciones ICH y controles de calidad GMP. El conocimiento de su perfil de degradación | límites aceptables y condiciones de estabilidad facilita la gestión de riesgos y la implementación de procedimientos analíticos y de liberación de lote.
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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