El epímero C-2 de DGA-Condensed constituye una impureza estereoquímica relevante en el perfil de impurezas que requiere identificación y control riguroso. La epimerización en el centro C-2 altera la configuración relativa y provoca diferencias en propiedades fisicoquímicas y en el comportamiento cromatográfico | facilitando su separación por HPLC y cromatografía quiral; su caracterización se realiza mediante RMN 1D/2D y espectrometría de masas para confirmar estructuras y proporciones. Los límites de especificación se establecen según riesgo farmacéutico y estabilidad; las estrategias de mitigación incluyen optimización de condiciones de síntesis | control de pH y temperatura y técnicas de purificación dirigidas.
Referencias
“Dapagliflozin: MedlinePlus Drug Information.†Medlineplus.gov, Feb. 2022, medlineplus.gov/druginfo/meds/a614015.html.
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