Dapagliflozin Impurity 19 (CAS 21739-92-4) | identificado como ácido 2-cloro-5-bromobenzoico | es una impureza halogenada relevante en el perfil químico del dapagliflozin. Su detección y cuantificación se realiza por HPLC-UV y LC-MS con confirmación por RMN para establecer estructura y pureza relativa. Se presenta como subproducto de etapas de halogenación o degradación intermedia y requiere control dentro de especificaciones de desarrollo farmacéutico. La caracterización incluye tiempo de retención | espectros de masas y fragmentación | límites de cuantificación y estrategias de reducción en proceso. Datos analíticos robustos soportan planes de control y validación según buenas prácticas regulatorias.
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