Alogliptin Impurity 12 (CAS 2089611-85-6) es una impureza relacionada identificada en el perfil de degradación y síntesis del principio activo. Presenta propiedades fisicoquímicas definidas que requieren monitoreo riguroso por su potencial impacto en la pureza y la seguridad del lote. Su detección y cuantificación se realizan mediante HPLC acoplada a espectrometría de masas y detección fotométrica | con métodos validados que establecen límites de detección y cuantificación. La formación se asocia a reacciones de degradación durante síntesis y almacenamiento | por lo que se implementan criterios de aceptación | estudios de estabilidad forzada y estrategias de control de proceso para asegurar cumplimiento regulatorio y consistencia del perfil de impurezas.
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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