Impureza 3-Fluro Diketoatorvastatin Derivative é um contaminante estrutural identificado em lotes de atorvastatina diketo-derivados contendo substituição fluoro no anel aromático. Caracteriza-se por massa molecular diferenciada e sinais NMR adicionais atribuíveis ao grupo fluoro e ao sistema diketo | sendo detectável por HPLC com detecção UV e confirmado por LC-MS/MS e RMN 1H/13C. Sua presença pode afetar a pureza farmacêutica e perfis de degradantes | exigindo investigação de vias de formação | estudos de estabilidade forçada e estabelecimento de limites de aceitação baseados em toxicidade e avaliação de impurezas genotóxicas. Controles de processo e métodos analíticos validados são essenciais para mitigação e monitoramento.
Referências
“Atorvastatin (Oral Route) Description and Brand Names – Mayo Clinic.” Mayoclinic.org, 2023, www.mayoclinic.org/drugs-supplements/atorvastatin-oral-route/description/drg-20067003#:~:text=Atorvastatinisusedtogetherwith,fatscloggingthebloodvessels. Accessed 15 Apr. 2023.
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