Impureza Defluoro Atorvastatin Acetonide tert-Butyl Ester (CAS 1105067-91-1) apresenta-se como impureza relacionada ao processo que pode comprometer o perfil de pureza do intermediário e do material farmacêutico ativo | exigindo caracterização rigorosa. Identificação e quantificação por HPLC com detecção UV/diode array | LC-MS e RMN são fundamentais para determinar estrutura | níveis e possíveis vias de formação por desfluoração ou proteção incompleta do acetonídeo. Estudos de estabilidade forçada definem sua tendência à degradação e ajudam a estabelecer limites aceitáveis conforme diretrizes regulatórias. Estratégias de controle incluem otimização das etapas sintéticas | purificação cromatográfica e especificações analíticas robustas.
Referências
McIver, Lindsey A., and Momin S. Siddique. “Atorvastatin.” Nih.gov, StatPearls Publishing, 15 May 2022, www.ncbi.nlm.nih.gov/books/NBK430779/.
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