A Impureza EP C da rosuvastatina, também designada 5-Oxo Rosuvastatina, 3-Hidroxi-5-ceto Rosuvastatina ou Rosuvastatina cetona, sal de cálcio, é um produto de degradação oxidativa carbonílica da cadeia lateral da estatina, não se enquadrando como impureza genotóxica de classe. O material corresponde ao CAS 1422514-05-3 e apresenta a composição C22H25FN3O6S- 1/2 Ca++ com massa molecular de 498.55 g/mol. A sua formação é compatível com hidroxilação seguida de oxidação na cadeia lateral pirrólica 5-hidroxilada. A caracterização geralmente exige LC-MS/MS, espectrometria de massas de alta resolução e RMN, com HPLC-UV para separação cromatográfica e perfil de impurezas.
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