Apixaban Carboxylic Acid Impurity, CAS 503614-92-4, ist eine strukturell definierte prozess- oder abbauassoziierte Verunreinigung des Faktor-Xa-Inhibitors Apixaban und entspricht 1-(4-Methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5-dihydropyrazolo[3,4-c]pyridine-3-carbonsäure. Mit der Summenformel C25H24N4O5 und einer Molmasse von 460,48 g/mol handelt es sich um das Carbonsäure-Analog am heteroaromatischen Kern. Die Entstehung kann aus hydrolytischen Umsetzungen oder Synthesenebenreaktionen während des Aufbaus des Pyrazolopyridin-Gerüsts resultieren. Aufgrund der geringen Flüchtigkeit und Polarität erfordert die Identifizierung üblicherweise LC-MS/MS, hochauflösende MS und orthogonale HPLC-UV-Verfahren unter Berücksichtigung von ICH Q3A/Q3B.
References
Budovich, Aliaksandr, et al. “Role of Apixaban (Eliquis) in the Treatment and Prevention of Thromboembolic Disease.” Pharmacy and Therapeutics, vol. 38, no. 4, 1 Apr. 2013, pp. 206–231, www.ncbi.nlm.nih.gov/pmc/articles/PMC3684191/#b5-ptj3804206. Accessed 24 Jan. 2022.
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![5-((4-(3-carbamoyl-1-(4-methoxy phenyl)-7-oxo-1,4,5,7-tetrahydro-6H-pyrazolo[3,4-c]pyridin-6-yl)phenyl) (nitroso) amino) pentanoic acid](https://veeprho.com/wp-content/uploads/2023/06/5-4-3-carbamoyl-1-4-methoxy-phenyl-7-oxo-1-4-5-7-tetrahydro-6H-pyrazolo-3-4-c-pyridin-6-yl-phenyl-nitroso-amino-pentanoic20acid.png "5-((4-(3-carbamoyl-1-(4-methoxy phenyl)-7-oxo-1,4,5,7-tetrahydro-6H-pyrazolo[3,4-c]pyridin-6-yl)phenyl) (nitroso) amino) pentanoic acid")
