O-Desethyl Dapagliflozin, também designado Dapagliflozin FP-Impurity A, é um análogo desetilado clorado do inibidor de SGLT2 dapagliflozina, associado ao CAS 864070-37-1. Com fórmula molecular C19H21ClO6 e massa molecular de 380.82 g/mol, diferencia-se do fármaco-mãe pela perda do grupo etil no oxigénio fenóxico, compatível com intermediário de síntese, subproduto de processo ou degradante por hidrólise ou desalquilação. A sua identificação e quantificação requerem habitualmente LC-MS/MS, LC-MS de alta resolução e métodos ortogonais por LC-UV, enquanto a confirmação estrutural é suportada por RMN. Como impureza relacionada, é avaliada no âmbito de estruturas regulatórias de controlo de impurezas.
Referências
Haider, Kashif, et al. “Synthetic Strategy and SAR Studies of C-Glucoside Heteroaryls as SGLT2 Inhibitor: A Review.†European Journal of Medicinal Chemistry, vol. 184, Dec. 2019, p. 111773, https://doi.org/10.1016/j.ejmech.2019.111773.?Docherty, Kieran F., et al. “Effects of Dapagliflozin in DAPA-HF according to Background Heart Failure Therapy.†European Heart Journal, vol. 41, no. 25, Mar. 2020, pp. 2379–92, https://doi.org/10.1093/eurheartj/ehaa183.
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