Información adicional sobre el Rosuvastatin 3S 5S isomer
Fármaco de origen
Rosuvastatin
Nombre IUPAC
(3S, 5S, 6E)-7-[4-(4-fluorophenyl)-2-(N-methylmethanesulfonamido)-6-(propan-2-yl)pyrimidin-5-yl]-3, 5-dihydroxyhept-6-enoic acid Calcium salt
Sinónimos
N/A
Descripción
El isómero 3S 5S de rosuvastatina es una impureza estereoisomérica relevante en el control de calidad del principio activo | cuya presencia puede alterar el perfil farmacológico y la pureza en lote. Su detección y cuantificación se realizan mediante HPLC quiral validado complementado con espectrometría de masas y RMN para confirmación estructural y determinación de la rotación óptica. La caracterización rigurosa permite establecer límites de aceptación en especificaciones analíticas y evaluar su impacto en estabilidad | seguridad y eficacia. El cumplimiento de guías regulatorias de impurezas y la implementación de métodos validados garantizan trazabilidad y reducción de riesgo en desarrollo y manufactura.
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