Impureza Empagliflozina 62 é um subproduto estruturalmente relacionado ao ativo | caracterizado por um resíduo de D-glicose ligado em C-1 a um núcleo aromático 4-clorado substituído por um grupo fenilmetílico que carrega um éter com (3S)-tetrahidrofurano. Essa impureza apresenta maior polaridade relativa ao princípio ativo | comportamento cromatográfico distinto em HPLC com tempos de retenção deslocados e espectros LC-MS que evidenciam fragmentação do glicósido e sinais característicos em 1H e 13C NMR. Relevante para controle de qualidade | sua identificação | quantificação e estabilidade devem ser avaliadas por métodos validados | e estratégias de purificação e otimização do processo de síntese são recomendadas para limitar sua formação.
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