Atorvastatin EP Impurity B (Free Base), CAS 842103-12-2, é uma impureza sintética estruturalmente relacionada à rota de fabricação do atorvastatin cálcico e às transformações da cadeia lateral da estatina sob condições de processo ou de estresse. Com fórmula molecular C33H35FN2O5 e massa molar de 558,65 g/mol, mantém o farmacóforo pirrol fluorofenil, mas difere do fármaco por arranjo estereoquímico ou de substituintes, o que altera o comportamento cromatográfico e o perfil de impurezas. A determinação geralmente exige LC em fase reversa com UV, LC-MS/MS ou MS de alta resolução, com caracterização ortogonal por RMN e, quando necessário, LC-ELSD ou HPLC-UV para quantificação em níveis traço no contexto regulatório.
Referências
McIver, L. A., & Siddique, M. S. (2022, September 2). Atorvastatin. Retrieved October 31, 2022, from Nih.gov website: https://www.ncbi.nlm.nih.gov/books/NBK430779/
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