Atorvastatin Dibromo Impurity (CAS 2514955-94-1) es una impureza halogenada detectada en materiales de partida y en etapas de síntesis de atorvastatina | caracterizada por la presencia de dos átomos de bromo que generan un patrón isotópico distintivo en espectrometría de masas. Su mayor peso molecular y lipofilicidad pueden alterar el perfil de cristalinidad y la solubilidad del API | afectando la pureza y estabilidad. Requiere control riguroso mediante HPLC acoplado a MS y validación de métodos para cuantificación y límites de aceptación según guías regulatorias. La identificación temprana y la eliminación controlada son críticas para asegurar cumplimiento y calidad del lote.
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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