La impureza Atorvastatin Desfluoro Diol Ester es un subproducto estructural crítico en el perfil de impurezas de atorvastatina que puede afectar la pureza y estabilidad del API; presenta mayor polaridad que el principio activo y comportamiento cromatográfico diferenciado | lo que exige métodos analíticos sensibles y selectivos. Se detecta y caracteriza eficazmente mediante HPLC acoplada a espectrometría de masas con patrones de fragmentación específicos | y surge por vías de desfluoración o reacciones secundarias del diol y del éster durante síntesis y almacenamiento. Su control mediante condiciones de reacción optimizadas | pasos de purificación robustos y límites basados en estudios forzados es esencial para cumplimiento de guías regulatorias y seguridad del producto.
Referencias
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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