Impureza do 2-Fluoro Atorvastatin (Sal de Sódio) | CAS 1346598-86-4 | caracteriza-se por um perfil que inclui isômeros posicionais fluoreados | produtos de desfluoração | intermediários de reação incompletos | subprodutos de desalkilação e impurezas hidrolíticas e oxidativas. A detecção e quantificação são realizadas por HPLC acoplada a LC-MS e confirmação por RMN para delinear estrutura e nível de resíduos iônicos. Limites de especificação seguem diretrizes regulatórias aplicáveis e são monitorados por controle de processo | purificação cromatográfica e validação de limpeza. O perfil de impurezas influencia estabilidade e segurança do material de referência e exige investigação de origem e estratégias de mitigação.
Referências
McIver, L. A., & Siddique, M. S. (2022, May 15). Atorvastatin. Retrieved August 19, 2022, from Nih.gov website: https://www.ncbi.nlm.nih.gov/books/NBK430779/
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