La impureza EP F de atorvastatina, también descrita como ácido amida, ácido diamida o impureza diamino en base libre, es una sustancia relacionada de origen de proceso y degradativo asociada con la síntesis de atorvastatina y reacciones secundarias de acoplamiento amídico. Corresponde al CAS 887196-24-9, fórmula molecular C40H48FN3O8 y peso molecular de 717.84 g/mol. Su estructura sugiere sobreactivación o reordenamiento hidrolítico de la función amida de la cadena lateral, más que un grupo de alerta mutagénica clásico. Su caracterización suele requerir LC-MS/MS, MS de alta resolución y métodos ortogonales HPLC-UV o LC-ELSD, con confirmación por RMN cuando se aísla. Su presencia se evalúa en perfiles de impurezas y límites de especificación bajo marcos farmacopeicos e ICH.
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