Dapagliflozina bromo lactona é uma impureza relacionada identificada durante a síntese e estabilidade do ingrediente ativo | caracterizada por formação de um anel lactona bromado via bromação intramolecular e ciclização secundária. A presença desta impureza pode afetar o perfil de pureza e exigirá quantificação sensível por HPLC com detecção UV acoplada a LC-MS para confirmação de massa e fragmentação | além de caracterização estrutural por RMN. Estratégias de controle incluem otimização de etapas sintéticas | purificação cromatográfica e estudos de degradação forçados para definir limites aceitáveis conforme ICH Q3A/Q3B. Documentação analítica robusta e critérios de liberação são essenciais para gerenciamento de risco.
Referências
Braem, Alan, et al. “Discovery and Development of Selective Renal Sodium-Dependent Glucose Cotransporter 2 (SGLT2) Dapagliflozin for the Treatment of Type 2 Diabetes.†Topics in Medicinal Chemistry, 2014, pp. 73–94, https://doi.org/10.1007/7355_2014_41.?Wiviott, Stephen D., et al. “The Design and Rationale for the Dapagliflozin Effect on Cardiovascular Events (DECLARE)–TIMI 58 Trial.†American Heart Journal, vol. 200, June 2018, pp. 83–89, https://doi.org/10.1016/j.ahj.2018.01.012.?
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