title: Determination of residual Kryptofix 2.2.2 levels in [18F]-labeled radiopharmaceuticals for human use.
abstract: 4,7,13,16,21,24-Hexaoxa-1,10-diazabicyclo[8.8.8]hexacosane (Kryptofix 2.2.2) is used in the routine preparation of [18F]-labeled tracers employed in positron emission tomography (PET) imaging. Confirming the absence of Kryptofix in radiopharmaceuticals is a quality control criterion required before they can be released for human use. Analysis of Kryptofix levels using the iodoplatinate spot-test can be complicated by false-positive results due to nitrogen containing tracers and/or false-negative results caused by added stabilizers. To overcome this issue, we have developed a universal TLC method for the rapid and reliable determination of Kryptofix levels in the wide range of fluorine-18 radiopharmaceuticals we prepare, including complex multi-component formulations.
authors.affiliation: Division of Nuclear Medicine, Department of Radiology, University of Michigan Medical School, Ann Arbor, MI 48109, USA.
authors.forename: Peter J H
authors.initials: PJ
authors.lastname: Scott
authors.forename: Michael R
authors.initials: MR
authors.lastname: Kilbourn
mesh_terms: D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000032:analysis*; D002855:Chromatography, Thin Layer / Q000379:methods; D005462:Fluorine Radioisotopes / Q000737:chemistry* / Q000302:isolation & purification; D006801:Humans; D007202:Indicators and Reagents / Q000032:analysis; D049268:Positron-Emission Tomography; D019275:Radiopharmaceuticals / Q000737:chemistry* / Q000302:isolation & purification
chemical_list: D019086:Bridged Bicyclo Compounds, Heterocyclic; D005462:Fluorine Radioisotopes; D007202:Indicators and Reagents; D019275:Radiopharmaceuticals; C006071:cryptating agent 222