Impureza de lactona diepóxido da atorvastatina é um subproduto oxidativo formado durante etapas de síntese ou por degradação pós-produção | caracterizado por anéis epóxido conjugados e ciclização lactona que alteram o perfil físico-químico do princípio ativo. Apresenta solubilidade reduzida e comportamento lipofílico que pode dificultar a purificação. A identificação e quantificação exigem técnicas sensíveis como LC-MS | HPLC com detecção UV e RMN para confirmar estrutura e estereoquímica. A estabilidade é comprometida por condições ácidas | térmicas e agentes oxidantes | tornando essencial controle de processo | minimização das etapas reativas e critérios analíticos em especificações para atender limites regulatórios e garantir qualidade do lote.
Referências
McIver, Lindsey A., and Momin S. Siddique. “Atorvastatin.” Nih.gov, StatPearls Publishing, 5 Jan. 2019, www.ncbi.nlm.nih.gov/books/NBK430779/. Ramkumar, Satish, et al. “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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