Impureza dímero de dapagliflozina presente como subproducto de síntesis o degradación | caracterizada por masa molecular doble y perfil cromatográfico distintivo. Esta impureza exige monitoreo riguroso en control de calidad mediante métodos analíticos validados como HPLC con detección UV y espectrometría de masas para confirmar estructura y cuantificar niveles. Se evalúan parámetros de retención | fragmentación y límites de detección y cuantificación para garantizar cumplimiento con especificaciones internas y guías regulatorias ICH sobre impurezas. La identificación temprana y el establecimiento de límites de aceptación facilitan la gestión de riesgos en el proceso y la optimización de pasos sintéticos para minimizar formación de dímeros.
Referencias
Anderson, S. L. (2014). Dapagliflozin efficacy and safety: a perspective review. Therapeutic Advances in Drug Safety, 5(6), 242–254. https://doi.org/10.1177/2042098614551938 ‌
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