Validation of 5 analytical methods (pH, peptide concentration, loss on drying radiochemical purity, peptide identity and purity) for quality control of the kits used for Ga-68 radiolabeling

Kits are gaining popularity as a known convenient labelling procedure for gallium-68 based radiopharmaceuticals in the Nuclear Medicine clinic. Cold kits are a benefit to small radiopharmaceutical sites, but their quality should be checked in the same way as if they were produced by big pharmaceutical producers. Set of data from different validated methods (pH, concentration, radiochemical purity, identity and loss on drying) are presented. Methods are validated according to European Pharmacopoeia and such are used for quality control of radiopharmaceutical kits.