Atorvastatin EP Impurity C, también denominado Atorvastatin Related Compound C, Fluoroatorvastatin o Atorvastatin Difluoro Analog, es una impureza relacionada con el proceso de síntesis del inhibidor de la HMG-CoA reductasa atorvastatina. La estructura, CAS 693794-20-6, fórmula molecular C33H34F2N2O5 y masa molecular 576.64 g/mol corresponden a un análogo lipófilo difluorado, no a un simple producto de degradación. Su origen suele asociarse con reacciones laterales de fluoración o desprotección incompleta durante la fabricación del principio activo. Su identificación y cuantificación requieren habitualmente LC-MS/MS, LC-MS de alta resolución y métodos ortogonales de HPLC-UV, dentro del marco regulatorio de ICH Q3A y Q3B.
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