Dapagliflozin C2 epímero (CAS 2133407-75-5) es una impureza estereoquímica relevante en el proceso de síntesis y estabilidad del dapagliflozina. Su identificación y cuantificación por HPLC con detección UV | LC-MS y corroboración por RMN es esencial para el perfil de impurezas y la conformidad regulatoria. Puede originarse por inversión estereoquímica durante reacciones de protección/desprotección o por condiciones de almacenamiento | afectando pureza y actividad. Se recomienda desarrollar métodos validados con límites de detección adecuados | criterios de aceptación basados en toxicología y estudios de degradación forzada para establecer controles de proceso eficaces y asegurar calidad del material farmacéutico.
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