Apixaban Chloro Impurity (CAS 2029205-64-7) | también conocida como p-demethoxy p-chloro apixaban y 1H-pyrazolo[3 | 4-c]pyridine-3-carboxamide 1-(4-chlorophenyl)-4 | 5 | 6 | 7-tetrahydro-7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl] | es una impureza clorada que aparece como subproducto en la síntesis y degradación de apixaban. Su perfil analítico se caracteriza por masa molecular específica detectable por LC-MS y señales distintivas en 1H-NMR | con retención en HPLC que difiere del principio activo. La identificación y cuantificación de esta impureza es crítica para el control de calidad | evaluación de estabilidad y cumplimiento de límites regulatorios | así como para el desarrollo de métodos de purificación y monitoreo durante el proceso.
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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