A Impureza éster metílico do apixabano (Apixaban Methyl Ester Impurity) | CAS 1074365-84-6 | também conhecida como Apixaban Related Compound E e formalmente identificada como 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 | é um subproduto de síntese que afeta o perfil qualitativo do princípio ativo. Apresenta comportamento cromatográfico e massa molecular específicos | detectáveis por HPLC | LC-MS e espectroscopia NMR. A sua ocorrência pode derivar de esterificação incompleta ou de reações laterais e influencia estabilidade e impurezas relacionadas; por isso exige caracterização | estabelecimento de limites por avaliação de risco e medidas de controlo de processo e purificação para garantir conformidade analítica e regulatória.
Referências
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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![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")
