Analytical procedure for quality control of 18F-Choline radiopharmaceutical.

Abstract

¹⁸Fluoromethylcholine (¹⁸F-Choline, ¹⁸F-FCH) has been produced using a home-made automatic synthesiser at 30 MeV Cyclotron Centre, 108 Military Central Hospital. In order to be licensed using for patients, the ¹⁸F-FCH radiopharmaceutical needs to meet the required quality specifications listed in the pharmacopeia. The objective of this study was to build up the analytical procedure and to perform for the 18F-FCH quality control followed the EuPh2017 pharmacopeia for the PET radiopharmaceutical. The result obtained confirmed that the total time to complete the test of one sample of the ¹⁸F-FCH was less than 35 min. Identifications of ¹⁸F-FCH, radiochemical purity, and ¹⁸F content were determined with accuracy >96% by High-performance liquid chromatography (HPLC) method and content of residual solvents consists of Ethanol, Acetonitrile, Dibromomethane, Dimethylethanolamine were determined with the accuracy >97% by Gas chromatography (GC) method.