A impureza Dapagliflozina (C2 | C3) epímero corresponde a um isómero estereogênico formado por inversão configuracional nos centros C2 e C3 da molécula de dapagliflozina. Tecnicamente | sua presença pode afetar o perfil de pureza | atividade farmacológica e estabilidade do lote | exigindo monitoramento e controle de qualidade rigoroso durante síntese e purificação. Métodos analíticos validados como HPLC quiral | LC-MS e RMN são recomendados para quantificação e caracterização estrutural | e estudos de degradação forçada ajudam a determinar vias formativas. O estabelecimento de limites regulatórios e critérios de aceitação | aliados a controles de processo e testes de liberação | garante que esta impureza permaneça dentro de parâmetros aceitáveis.
Referências
Raja, Mobeen, and Rolf K. H. Kinne. “Identification of Phlorizin Binding Domains in Sodium-Glucose Cotransporter Family: SGLT1 as a Unique Model System.†Biochimie, vol. 115, Aug. 2015, pp. 187–93, https://doi.org/10.1016/j.biochi.2015.06.003.?List, J. F., et al. “Sodium-Glucose Cotransport Inhibition with Dapagliflozin in Type 2 Diabetes.†Diabetes Care, vol. 32, no. 4, Dec. 2008, pp. 650–57, https://doi.org/10.2337/dc08-1863.?
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