Rosuvastatin (6S)-Isomer (Sodium Salt) (CAS 2125944-54-7) es una impureza estereoquímica observada durante la síntesis y el procesamiento de rosuvastatina; su presencia indica inversión parcial del centro quiral en C6 y puede alterar el perfil de pureza del material activo. La sal sódica afecta solubilidad y retención cromatográfica, por lo que su detección y cuantificación mediante HPLC quiral, LC-MS y caracterización por RMN 1H/13C son imprescindibles. Esta impureza puede generarse por racemización o condiciones de degradación y requiere estudios de estabilidad, límites analíticos definidos y control según guías regulatorias para minimizar riesgos de calidad y seguridad.
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