Apixaban Methyl Ester Impurity (CAS 1074365-84-6) | designada como Apixaban Related Compound E y químicamente Methyl 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4 | 5 | 6 | 7-tetrahydro-1H-pyrazolo[3 | 4-c]pyridine-3-carboxylate | es una impureza sintética y/o de degradación relevante en el perfil de pureza del apixabán. Presenta grupos éster y cetona que afectan su polaridad y retención en cromatografía líquida | siendo detectable por HPLC-UV y LC-MS y caracterizable por RMN y espectrometría de masas. Su formación puede originarse en pasos de esterificación o por transesterificación y requiere límites de especificación | procedimientos de liberación y estudios de estabilidad para mitigar riesgos de impurezas relacionadas en el control de calidad.
Referencias
Hurst, Katherine, et al. “Quick Reference Guide to Apixaban.†Vascular Health and Risk Management, vol. Volume 13, July 2017, pp. 263–267, 10.2147/vhrm.s121944.
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