Impureza relacionada con Alogliptin Benzoato (CAS 850649-62-6) caracterizada por variaciones en el perfil cromatográfico y masas moleculares adyacentes que pueden originarse por degradación durante síntesis o almacenamiento. Su identificación requiere análisis LC-MS | HPLC con detector UV y validación por límites de detección y cuantificación. Esta impureza afecta la pureza farmacéutica y la estabilidad del lote | por lo que debe incluirse en las especificaciones y en el plan de control de calidad mediante límites y pruebas de eliminación. Estrategias de mitigación incluyen optimización de condiciones de reacción | control de humedad y temperatura | y estudios de degradación forzada para la calificación y trazabilidad.
Referencias
“Alogliptin Benzoate for the Treatment of Type 2 Diabetes.â€Â Expert Opinion on Pharmacotherapy, 2012, www.tandfonline.com/doi/abs/10.1517/14656566.2012.656088.
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