Impureza Tert-Butyl (3S | 5S)-6-Chloro-3 | 5-dihydroxyhexanoate (CAS 325471-28-1) relevante en perfiles de impurezas por su configuración estereoquímica y grupos funcionales reactivos; se genera frecuentemente como subproducto en etapas de cloración o protección y puede afectar la pureza final y la estabilidad del lote. Su identificación y cuantificación se realizan mediante HPLC y LC-MS complementados con RMN para confirmar estereoquímica. Debido a su polaridad y punto de ebullición intermedio requiere estrategias de purificación específicas como cromatografía en fase normal o flash y monitorización mediante límites especificados en control de calidad para minimizar riesgos en procesos farmacéuticos y químicos.
Referencias
Luvai, Ahai, et al. “Rosuvastatin: A Review of the Pharmacology and Clinical Effectiveness in Cardiovascular Disease.†Clinical Medicine Insights: Cardiology, vol. 6, Jan. 2012, p. CMC.S4324, https://doi.org/10.4137/cmc.s4324. ‌
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