Atorvastatin EP Impurity C, también denominado Atorvastatin Related Compound C, Atorvastatin Difluoro Impurity o Fluoroatorvastatin, es un análogo fluorinado de atorvastatina en forma de sal cálcica (CAS 693793-53-2). Con fórmula molecular C66H66CaF4N4O10 y peso molecular de 1191,34 g/mol, incorpora halógeno en el patrón aromático del andamiaje estatínico, por lo que no corresponde a un degradante simple. Estas especies suelen originarse por arrastre de impurezas de síntesis o incorporación errónea en etapas finales de acoplamiento y se caracterizan mediante LC-MS/MS, espectrometría de masas de alta resolución y, de forma preferente, RMN de 19F con perfilado por LC-UV.
Referencias
Agrawal, Deepak, et al. ‘To Study the Effect of High Dose Atorvastatin 40 Mg versus 80 Mg in Patients with Dyslipidemia.’ Indian Heart Journal, vol. 70, Dec. 2018, pp. S8–12, https://doi.org/10.1016/j.ihj.2018.01.034.
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