6α | 9α-Difluoroprednisolone 21-acetato (CAS 52-70-0) es una impureza crítica en procesos de síntesis de corticosteroides cuya doble fluoración en posiciones 6α y 9α y la acetilación en C21 afectan polaridad y lipofilicidad | influyendo en el perfil de pureza y la estabilidad del lote. Su identificación y cuantificación se realiza habitualmente por HPLC-UV y LC-MS/MS con confirmación estructural por RMN 1H/13C y espectrometría de alta resolución. El control incluye estudios de degradación forzada | establecimiento de límites según guías ICH y métodos cromatográficos validados para garantizar el cumplimiento del perfil de impurezas.
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To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
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