Atorvastatin Related Compound E, también denominado Atorvastatin EP Impurity E, Ent-Atorvastatin y sal de calcio del isómero 3S,5S de atorvastatina, corresponde al enantiómero estereoquímico de atorvastatina y no a un fragmento de degradación ni a una estructura de alerta genotóxica. CAS 1105067-88-6; fórmula molecular C66H68CaF2N4O10; peso molecular 1155.34 g/mol. Su presencia suele indicar inversión estereoquímica o arrastre desde la síntesis asimétrica y debe diferenciarse de la configuración 3R,5R farmacológicamente activa. La caracterización en niveles traza requiere LC quiral, LC-MS/MS y espectrometría de masas de alta resolución para resolver isómeros y especies asociadas a la sal. El contexto regulatorio se centra en la pureza estereoquímica y en los límites de impurezas derivados del proceso.
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