Empagliflozin 1-Hydroxy-Impurity, auch Empagliflozin Impurity B genannt, ist ein prozessbezogenes oxidatives Derivat des C-Glucosid-Gerüsts des Natrium-Glukose-Cotransporter-2-Inhibitors. Diese Verunreinigung mit der CAS-Nummer 1279691-35-8 besitzt die Summenformel C23H27ClO8 und eine Molmasse von 466,91 g/mol. Die 1-hydroxylierte Substitution verändert Polarität und chromatographisches Verhalten gegenüber dem Wirksubstanzmolekül und ist mit metabolischer oder synthetischer Oxidation im benzylen Bereich des Arylether-Systems vereinbar. Für die Charakterisierung werden typischerweise LC-MS/MS mit hochauflösender Massenbestätigung, ergänzt durch HPLC-UV oder LC-CAD, sowie bei Bedarf NMR zur Strukturzuordnung eingesetzt. Relevanz besteht für Impuritätsprofile, Abbauuntersuchungen und regulatorische Spezifikationsgrenzen.
References
‚Wanner, Christoph, et al. “Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.†New England Journal of Medicine, vol. 375, no. 4, July 2016, pp. 323–34, https://doi.org/10.1056/nejmoa1515920. ?Frampton, James E. “Empagliflozin: A Review in Type 2 Diabetes.†Drugs, vol. 78, no. 10, June 2018, pp. 1037–48, https://doi.org/10.1007/s40265-018-0937-z ‚
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