The purpose of this study was to evaluate the quality of the original and 3 generic formulations of Iopamidol injection.To do this,the free iodine concentration and osmotic pressure were measured.In addition,impurities were tested for using high performance liquid chromatography-tandem mass spectrometry.
There were no major differences between the original and generic formulations as regards free iodine concentration and osmotic pressure measurements,though one lot of the original formulation failed the free iodine concentration test.However,in the HPLC analysis,some substances not present in the original product were detected in the generic formulations.One of them was identified as DM 1/2,a substance related structurally to Iopamidol.
