Impureza cloro de Apixaban (CAS 2029205-64-7) | também conhecida como p-demethoxy p-chloro apixaban e formalmente descrita como 1H-pyrazolo[3 | 4-c]pyridine-3-carboxamide com substituição 1-(4-clorofenil)-4 | 5 | 6 | 7-tetrahidro-7-oxo-6-[4-(2-oxo-1-piperidinil)fenil] | é um marcador crítico de qualidade associado a variações na síntese e estabilidade do princípio ativo. A presença do substituinte cloro modifica polaridade e massa molecular | afetando perfil cromatográfico e sinais em espectrometria de massas. A sua identificação e quantificação por técnicas analíticas avançadas | como HPLC | LC-MS e RMN | suportam estudos de lote | investigação de impurezas e cumprimento de especificações regulatórias.
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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