La impureza Rosuvastatin KSM (4S | 6R)-isomer es un isómero configuracional relevante en el control de calidad de rosuvastatina. Presenta propiedades fisicoquímicas y retención cromatográfica diferenciadas que requieren métodos analíticos validados como HPLC con detección UV o LC-MS para cuantificación y perfil de impurezas. Su presencia puede afectar la pureza del principio activo y la estabilidad del lote si no se controla mediante condiciones de síntesis optimizadas y etapas de purificación específicas. Se recomienda establecer especificaciones basadas en límites toxicológicos y estudios de degradación forzados para garantizar conformidad regulatoria y seguridad del producto farmacéutico.
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