A Study of the Radiochemical Purity Determination Method for 99Tcm-DMSA Injection
Objective To establish a radiochemical purity determination method for 99Tcm-DMSA injection.Methods We examined the specificity of radiochemical purity determination methods with EP,USP and current standards which are currently used in China.By optimizing the stationary phase and developing agents,we analyze peak shape,specificity,development duration and other related factors under various chromatographic conditions.Through this process,a radiochemical purity determination method was developed and the analytical method was validated.Results The current methods suffered issues such as insufficient specificity,peak tailing,and long development duration.After chromatographic conditions were optimized,a dual-system determination method was established.ITLC-SG was used as the stationary phase,while butanone and n-butanol saturated with 0.3 mol/L and hydrochloric acid was used as developing solvent.The radiochemical purity of 99Tcm-DMSA was calculated based on the content of pertechnetate(99Tcm)ion in the butanone system(Rf value 1.0)and reduced hydrolyzed technetium(Rf value 0.0)in the n-butanol system.Conclusion The method established in this study can be used to determine the radiochemical purity of 99Tcm-DMSA injection.
万方数据
