Characterization of the second generation of Pars-GalluGen generator (68Ge/68Ga generator) and quality control of its eluate

Gallium-68 (68Ga) is a radionuclide widely used for diagnostic purposes in Nuclear Medicine. With the availability of 68Ge/68Ga generators, the radiopharmaceutical industry is currently focused on developing this generator. The development and application of 68Ge/68Ga generators remain a hot topic in nuclear medicine. In recent years, Pars Isotope Company in Iran has produced 68Ge/68Ga generators (Pars-GalluGen generator) that are eluted with 5 ml of 0.6 M hydrochloric acid. Additionally, Pars Isotope has developed the second generation of Pars-GalluGen generators. This new generator is based on a SnO2-TiO2 resin matrix and is eluted with 3 ml 0.1 M hydrochloric acid. This research aimed to determine the main characteristics of the second generation of Pars-GalluGen generators and evaluate their quality control. The results obtained indicate that this generator meets all specifications of the European Pharmacopoeia for use and has better performance characteristics, including higher chemical, radiochemical, and radionuclide purity, as well as a higher elution yield compared to the first generation.