Examination of metallic impurities of 68Ge/68Ga generators used for radioactive labeling of peptides in clinical PET applications

Abstract

Background/aim Especially suitable for PET due to its nuclear physical and radiochemical properties, the positron emitter Gallium-68 (68Ga) occurs by electron capture from Germanium-68 (68Ge). In such a radionuclide generator, the germanium is bound to an insoluble, inert column matrix and forms a secular radioactive balance with 68Ga obtained in the hour. As a result of the limited radiochemical selectivity of the elution process, the eluate obtained is basically contaminated with the main nuclide traces, so that the eluate becomes a mixture of 68Ga and 68Ge radionuclides. Also, the generator eluate contains a number to metal cations that reduce specific radioactivity and can compete with 68Ga. The presence of toxic metal that can be found in the eluate carries the risks of contamination at every step from the production of generators to radiopharmaceutical production. Materials and method In our study, by collecting the eluate of the 68Ge/68Ga generators used with different identities in different centers in Turkey, we report comparative analysis of metal contamination in the generator eluate. The eluates of 68Ge/68Ga generators to five different identities were collected. Eluates were analyzed by inductively coupled plasma–mass spectrometry. Results and Conclusion As a result, each generator contains metallic impurities different from its certificate.

Good practices for 68Ga radiopharmaceutical production

“…Metallic impurities play an important role in the quality of 68 Ga as a starting material (Chakravarty et al 2016 ; Cusnir et al 2019 ; Ugur et al 2021 ; Petrik et al 2010 ). In the European Pharmacopoeia (Ph.…”