La impureza Open Ring de dapagliflozina (CAS 2100872-88-4) es un producto de degradación que resulta de la apertura del anillo durante síntesis | purificación o almacenamiento | y requiere vigilancia en el perfil de impurezas del principio activo. Técnicamente | su presencia puede afectar la estabilidad | la pureza y el perfil farmacológico | por lo que su detección y cuantificación mediante HPLC | LC-MS y RMN es esencial para el control de calidad. Los procedimientos de mitigación incluyen optimización de condiciones de reacción | controles de pH y humedad | y establecimiento de límites conforme a guías regulatorias ICH | junto con métodos validados para garantizar especificidad y sensibilidad analítica.
Referencias
“Formulation of Amorphous Ternary Solid Dispersions of Dapagliflozin Using PEG 6000 and Poloxamer 188: Solid-State Characterization, Ex Vivo Study, and Molecular Simulation Assessment.†Drug Development and Industrial Pharmacy, 2020, www.tandfonline.com/doi/abs/10.1080/03639045.2020.1802482.?Dhillon, Sohita. “Dapagliflozin: A Review in Type 2 Diabetes.†Drugs, vol. 79, no. 10, June 2019, pp. 1135–46, https://doi.org/10.1007/s40265-019-01148-3.
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