N-Nitroso Rivaroxaban Open-Ring Acid Impurity | também referida como Rivaroxaban Nitrosamine Impurity I | é uma impureza nitrosamina de anel aberto identificada em processos de produção de rivaroxabana; forma-se por nitrosação de precursores amínicos sob condições nitrosantes e acídicas e representa preocupação toxicológica por seu potencial genotóxico | exigindo controlo rigoroso. A monitorização analítica é realizada por LC-MS/MS e HPLC acoplada a espectrometria de massas com estratégias de enriquecimento e validação de método que asseguram limites de especificação baixos. A gestão de risco inclui remoção de precursores | controlo de pH | quenchers redutores e etapas de purificação e validação alinhadas com orientações regulatórias para nitrosaminas.
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