Alogliptin Impurity 26 (CAS 865759-10-0) es una impureza orgánica identificada durante el desarrollo y control de calidad del alogliptin | caracterizada por un perfil cromatográfico y espectrométrico distintivo. Se detecta y cuantifica por HPLC con detección UV y se confirma por espectrometría de masas y resonancia magnética nuclear cuando es necesario | lo que permite definir su masa molecular y patrones de fragmentación. Su estudio facilita la comprensión de vías de degradación y rutas sintéticas que generan esta impureza | la definición de límites de especificación y la validación de métodos analíticos conforme a guías regulatorias ICH | asegurando control robusto y trazabilidad.
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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