La impureza 6,7-Dihydro O-Butyl-Rosuvastatin, identificable también como (3R,5R)-t-Butyl 7-(4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyheptanoate, muestra un aumento de lipofilicidad y una variación de masa precisa que la distingue del compuesto principal; estas propiedades afectan su retención en HPLC y su patrón de fragmentación en LC-MS, facilitando su identificación por espectrometría de masas de alta resolución y confirmación estructural por RMN. Puede originarse por modificaciones en la cadena alquílica durante síntesis o almacenamiento y requiere perfilado de impurezas, límites especificados y métodos validados de análisis para control de calidad, estabilidad y cumplimiento regulatorio.
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