A impureza EP F da atorvastatina, também descrita como ácido amida da atorvastatina, ácido diamida ou impureza diamino em base livre, é uma substância relacionada de origem de processo e de degradação associada à síntese da atorvastatina e a reações secundárias de acoplamento amídico. Corresponde ao CAS 887196-24-9, fórmula molecular C40H48FN3O8 e massa molecular de 717.84 g/mol. A estrutura sugere sobreativação ou rearranjo hidrolítico da função amida da cadeia lateral, em vez de um grupo clássico de alerta mutagênico. A caracterização обычно requer LC-MS/MS, MS de alta resolução e métodos ortogonais por HPLC-UV ou LC-ELSD, com confirmação por RMN quando isolada. Sua avaliação ocorre em perfis de impurezas e definição de especificações sob referenciais farmacopeicos e da ICH.
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