La impureza Metabolito N-acetilado M-II de Alogliptina (CAS 2882929-91-9) es un subproducto de modificación N-acetil que altera la polaridad y el comportamiento cromatográfico respecto al principio activo. Presenta un perfil analítico distintivo detectable por LC-MS y HPLC con señales confirmatorias en RMN que requieren métodos de extracción y separación optimizados para evitar coeluciones. Su presencia plantea retos en control de impurezas por formación durante síntesis y metabolismo y exige cuantificación a niveles de trazas | límites de detección adecuados y estudios de estabilidad para caracterizar su perfil de degradación y establecer criterios de aceptación en lotes farmacéuticos.
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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