title: Experimental implementation and proof of principle for a radionuclidic purity test solely based on half-life measurement.
abstract: In this paper we present the results of an experimental implementation of the method (Jørgensen et al., 2012) for testing the radionuclidic purity (RNP) of F-18 compounds. The overall limitations of the experimental methods and their possible impacts on RNP detectability have been identified. We have developed an GUI application for use as an easy and automated test tool in the production procedure. The test results show that this method fully complies with the requirements in the European Pharmacopoeia (Eur. Ph.) for RNP of FDG and F-18 Sodium Fluoride.
authors.affiliation: Hevesy Lab, DTU-Nutech, Technical University of Denmark, DK-4000 Roskilde, Denmark. Electronic address: sam_malone@me.com.
authors.forename: Thomas
authors.initials: T
authors.lastname: Jørgensen
authors.affiliation: Hevesy Lab, DTU-Nutech, Technical University of Denmark, DK-4000 Roskilde, Denmark.
authors.forename: Mikael
authors.initials: M
authors.lastname: Jensen
mesh_terms: D003198:Computer Simulation; D004340:Drug Contamination / Q000517:prevention & control*; D005240:Feasibility Studies; D005462:Fluorine Radioisotopes / Q000032:analysis* / Q000737:chemistry*; D006207:Half-Life; D008422:Materials Testing / Q000379:methods; D008956:Models, Chemical; D010865:Pilot Projects; D011381:Programming Languages; D011829:Radiation Dosage; D011874:Radiometry / Q000379:methods*; D019275:Radiopharmaceuticals / Q000032:analysis / Q000737:chemistry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012984:Software; D014584:User-Computer Interface
chemical_list: D005462:Fluorine Radioisotopes; D019275:Radiopharmaceuticals
keywords: Deadtime correction; F-18; Half life; Radionuclidic purity; Software; Statistical test