La impureza Defluoro Atorvastatin Acetonide tert-Butyl Ester (CAS 1105067-91-1) es un derivado estructural que puede formarse durante etapas de protección y acetonización en la síntesis y presenta retención y espectros semejantes al API | complicando la separación analítica; su cuantificación es crítica para el perfil de impurezas y la seguridad del lote. Se monitoriza por HPLC con detección UV y se confirma por LC-MS/MS para caracterizar masa y fragmentación. Los límites de aceptación deben fijarse conforme a ICH Q3A/B y datos toxicológicos. Las medidas de control incluyen optimización de condiciones sintéticas | purificación cromatográfica y validación rigurosa de métodos analíticos.
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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