Atorvastatin FXA Impurity (Free Base) é uma impureza relacionada ao processo de síntese da atorvastatina apresentada na forma de base livre | cuja presença pode comprometer a pureza e o perfil de segurança do API. Caracteriza-se por propriedades fisicoquímicas específicas que exigem monitoramento por HPLC com detecção UV | LC-MS para identificação e RMN para confirmação estrutural. Estudos de estabilidade e testes forçados ajudam a elucidar vias de degradação e a estabelecer limites de especificação em conformidade com diretrizes ICH. Estratégias de controle incluem otimização da etapa sintética | purificação cromatográfica e validação analítica para garantir remoção consistente e conformidade regulatória.
Referências
“Statin Therapy: Review of Safety and Potential Side Effects.” Acta Cardiologica Sinica, vol. 32, no. 6, Taiwan Society of Cardiology, 2016, pp. 631–39, https://doi.org/10.6515/ACS20160611A.
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