TLC investigation of the radiochemical purity of copper[64Cu] chloride solution

Abstract

BackgroundCopper[64Cu] chloride solution is commonly used as raw material for the preparation of radiopharmaceuticals, which can be used in PET imaging or as a paired nuclide for tumor theranostic. Quality control test of copper[64Cu] chloride solution for radiolabelling must be done before use, and the radiochemical purity test is the key item of quality control.PurposeThis study aims to establish a rapid and reliable method for radiochemical purity analysis of copper[64Cu] chloride solution, by screening the test conditions of stationary phase and mobile phase.MethodsiTLC-SG silica gel paper plate was used as the stationary phase, and the mixed solution of dichloromethane, acetonitrile, methanol and 0.05 mol∙L-1 HCl was used as the mobile phase. The reference solution was prepared by mixing the test solution with DTPA solution in equal volume. The test solution and the reference solution were loaded on the paper plate separately and developed using the mobile phase. The kinds of stationary phase, composition and proportion of the mobile phase were optimized.ResultsUnder the optimized conditions, the Rf of the test solution is greater than 0.9 and the Rf of the reference solution is less than 0.1, and the separation degree is greater than 1.0, which satisfies the system suitability of thin-layer chromatography (TLC).ConclusionsEstablished method in this study is simple, reliable and rapid for the detection of radiochemical purity of copper[64Cu] chloride solution, and complying with the technical requirements of European pharmacopoeia for the determination of radionuclide solution for radiolabelling.

Keywords

• copper[64cu] chloride solution
• radiochemical purity
• tlc
• quality control