A Review on Radiochemical Purity Analysis Methods of Radiopharmaceuticals

Radiopharmaceuticals means radionuclide preparations or labeled compounds for clinical diagnosis or therapeutic use. Radiochemical purity is one of the important judgment indexes to measure the quality of radiopharmaceuticals, which directly affects the clinical effect, it is very important to accurately determine and strictly control the radiochemical purity. In this paper, by querying and analyzing Chinese Pharmacopoeia 2020, European Pharmacopoeia 10.2, US Pharmacopoeia 43-NF38, and the related literature, making a analysis and summary on the characteristics, separation principle and application of commonly used radiochemical purity determination methods, including thin-layer chromatography (TLC), paper chromatography (PC), electrophoresis (EP) and high performance liquid chromatography (HPLC), which would help to establish a more scientific and reasonable standard of radiopharmaceuticals quality standards and to provide technical reference.