Impureza (3R | 5R)-Atorvastatin Amide (CAS 2125501-02-0) é um derivado relacionado detectado durante síntese e purificação da atorvastatina. Sua caracterização exige técnicas analíticas robustas incluindo 1H e 13C NMR | espectrometria de massas de alta resolução HRMS e cromatografia líquida de alta eficiência HPLC-UV/MS para determinar estrutura | massa e perfil de retenção. Estudos de degradação forçada identificam sua formação sob condições ácidas e redutoras | orientando estratégias de controle de processo e especificações. A qualificação toxicológica e limites de aceitação devem seguir guidelines ICH Q3A Q3B | garantindo monitorização por métodos validados e documentação para conformidade regulatória.
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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