Dapagliflozin Hydroxy (CAS 960404-86-8) es una impureza estructuralmente relacionada que requiere identificación y cuantificación precisas en el desarrollo farmacéutico. Su análisis se realiza típicamente por HPLC con detección UV y cromatografía líquida acoplada a espectrometría de masas para confirmación estructural | complementado por RMN y análisis de estabilidad forzada para definir rutas de formación. Es crítico establecer límites de especificación | investigar perfiles de degradación y validar métodos analíticos según guías ICH para garantizar control de calidad reproducible. La caracterización detallada facilita la evaluación del impacto en pureza del lote | procesos de purificación y aceptación en liberación de producto.
Referencias
“Dapagliflozin: MedlinePlus Drug Information.†Medlineplus.gov, Feb. 2022, medlineplus.gov/druginfo/meds/a614015.html.
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