Dapagliflozin Keto Impurity, também designada Dapagliflozin Related Compound 4 e Dapagliflozin FP Impurity C, é um análogo carbonílico relacionado ao processo do inibidor de SGLT2 dapagliflozina. O CAS 2169998-23-4 corresponde à fórmula C21H23ClO7, com massa molecular de 422,86 g/mol. Estruturalmente, reflete oxidação na região benzílica ou próxima ao cetal do arcabouço glucopiranosídico, compatível com sobreoxidação sintética ou degradação durante o armazenamento. Não é uma nitrosamina, mas permanece relevante no controle regulatório de impurezas. A detecção e quantificação em traços normalmente exigem LC-MS/MS, HR-LC-MS e HPLC-UV ortogonal, com RMN para confirmação estrutural.
Referências
“Facile and Green Synthesis of Dapagliflozin.†Synthetic Communications, 2019, www.tandfonline.com/doi/abs/10.1080/00397911.2019.1666283.“Long-Term Efficacy of Dapagliflozin in Patients with Type 2 Diabetes Mellitus Receiving High Doses of Insulin: A Randomized Trial: Annals of Internal Medicine: Vol 156, No 6.†Annals of Internal Medicine, 2012, www.acpjournals.org/doi/full/10.7326/0003-4819-156-6-201203200-00003.
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