Dapagliflozin Keto Impurity, también denominada Dapagliflozin Related Compound 4 y Dapagliflozin FP Impurity C, es un análogo carbonílico relacionado con el proceso del inhibidor SGLT2 dapagliflozina. El CAS 2169998-23-4 corresponde a C21H23ClO7, con un peso molecular de 422,86 g/mol. Desde el punto de vista estructural, refleja oxidación en la región bencílica o cercana al cetal del esqueleto glucopiranosídico, compatible con sobreoxidación sintética o degradación durante el almacenamiento. No es una nitrosamina, aunque sigue siendo pertinente en el control regulatorio de impurezas. Su identificación y cuantificación suelen requerir LC-MS/MS, HR-LC-MS y HPLC-UV ortogonal, con RMN para confirmación estructural.
Referencias
“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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