title: Radionuclidic purity tests in (18)F radiopharmaceutIcals production process.
abstract: Radionuclidic purity tests of (18)F radiopharmaceuticals (Na(18)F and fluorodeoxyglucose [(18)F]FDG) and radionuclide composition analysis of irradiated water [(18)O]H2O were performed. The measurements were conducted using a High-Purity Germanium (HPGe) detector and a liquid scintillation counter. Radionuclide identification and activity measurements were performed for samples from different stages of the production process. Most of the impurities were detected on QMA (quaternary methylammonium) anion exchange columns and in liquid wastes. Using liquid scintillation counting, the activity of (3)H resulting from the (18)O[p, (3)H](16)O reaction was determined. It was shown that all of the impurities were efficiently determined and eliminated in the radiopharmaceuticals synthesis process and that the final products meet the requirements set by relevant regulations.
authors.affiliation: National Centre for Nuclear Research Radioisotope Centre POLATOM, Andrzeja Sołtana 7, 05-400 Otwock, Poland. Electronic address: tomasz.dziel@polatom.pl.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Dziel
authors.affiliation: National Centre for Nuclear Research Radioisotope Centre POLATOM, Andrzeja Sołtana 7, 05-400 Otwock, Poland.
authors.forename: Zbigniew
authors.initials: Z
authors.lastname: Tymiński
authors.affiliation: IASON Sp. z o.o., Artwińskiego 3, 25-734 Kielce, Poland.
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Sobczyk
authors.affiliation: IASON Sp. z o.o., Artwińskiego 3, 25-734 Kielce, Poland.
authors.forename: Agata
authors.initials: A
authors.lastname: Walęcka-Mazur
authors.affiliation: IASON Sp. z o.o., Artwińskiego 3, 25-734 Kielce, Poland.
authors.forename: Przemysław
authors.initials: P
authors.lastname: Kozanecki
mesh_terms: D004339:Drug Compounding / Q000592:standards*; D004340:Drug Contamination / Q000517:prevention & control*; D005462:Fluorine Radioisotopes / Q000032:analysis* / Q000592:standards*; D008422:Materials Testing; D011044:Poland; D011786:Quality Control; D011874:Radiometry / Q000379:methods* / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D005462:Fluorine Radioisotopes
keywords: (18)F; Quality control; Radionuclidic purity; Radiopharmaceuticals