(3R, 5R, 6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3, 5-dihydroxy-6-heptenoic acid calcium salt
Sinónimos
(3R, 5R)-Rosuvastatin Calcium Salt
Descripción
Impureza isomérica de Rosuvastatina calcio identificada como (3R | 5R)-Isómero | CAS 1422515-55-6 | conocida también como (3R | 5R)-Rosuvastatin Calcium Salt. Esta impureza estereoquímica compromete la pureza óptica y la uniformidad del API | pudiendo influir en el perfil de degradación y en propiedades fisicoquímicas críticas. Es un determinante en los estudios de estabilidad y control de calidad | habitualmente monitorizada mediante cromatografía quiral y confirmada por LC-MS para verificación de masa y seguimiento de productos de degradación. Su cuantificación y los límites permitidos se definen según guías regulatorias e ICH para asegurar seguridad | eficacia y consistencia de lote.
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