Impureza Atorvastatin Diketo Amide 2-Fluoro Analog (CAS 1797905-42-0) é um degradante e subproduto sintético recorrente no processo de fabricação da atorvastatina | exigindo monitoramento analítico rigoroso. Caracteriza-se por massa molecular definida e assinatura por LC-MS | deslocamento de retenção em HPLC e sinais distintivos em RMN que facilitam sua identificação como impureza crítica. Sua presença pode afetar pureza e perfil farmacotoxicológico do lote | impondo limites de especificação | métodos de quantificação validados e estratégias de purificação. Estudos de estabilidade | vias de formação e controle de matérias primas são essenciais para mitigação | documentação regulatória e conformidade com boas práticas de qualidade.
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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