El isómero (3R | 5R) de la Rosuvastatina en forma de base libre (CAS 1094100-06-7) | identificado también como (3R | 5R | 6E)-7-[4-(4-Fluorofenil)-6-(1-metilalil)-2-[metil(metilsulfonil)amino]pirimidin-5-il]-3 | 5-dihidroxihept-6-enoico | se reconoce como una impureza crítica en el desarrollo y control de calidad farmacéutico. Su carácter estereoquímico exige métodos analíticos sensibles como HPLC quiral | LC-MS y RMN para cuantificación y caracterización. Puede formarse por racemización parcial o condiciones de síntesis y afectar perfil de pureza y estabilidad del lote. Se recomienda establecer límites específicos | procedimientos de muestreo y estrategias de eliminación durante la purificación para garantizar cumplimiento regulatorio y consistencia del producto.
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