Alogliptin Impurity 3 (CAS 1108732-05-3) | también conocida como (S)-Alogliptin | es una impureza quiral crítica derivada de rutas sintéticas y de racemización durante la síntesis de la sustancia activa. Su identificación exige técnicas analíticas robustas como HPLC en fase reversa | cromatografía quiral | LC-MS y RMN para confirmar estructura y relación estereoquímica. A nivel de calidad farmacéutica su presencia puede afectar pureza | perfil de seguridad y cumplimiento de especificaciones | por lo que se implementan límites de aceptación | procedimientos de purificación | control de condiciones de reacción y estudios de estabilidad. La caracterización exhaustiva y estrategias de mitigación son esenciales para asegurar conformidad regulatoria.
Referencias
Dineen, Laura, et al. “Alogliptin (Nesina) for Adults with Type-2 Diabetes.†Pharmacy and Therapeutics, vol. 39, no. 3, 1 Mar. 2014, pp. 186–202, www.ncbi.nlm.nih.gov/pmc/articles/PMC4005122/.
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