title: Analysis of residual solvents in 2-[(18)F]FDG by GC.
abstract: A gas chromatography method has been developed for the measurement of the residual acetone, ethanol and acetonitrile in 2-deoxy-2-[(18)F] fluoro-D-glucose (2-[(18)F]FDG), in accordance with the pending FDA revision on the drug. The detections limits were 0.1 ppm for all three solvents. Good precision and linearity were obtained over ranges spanning the allowable concentration levels proposed by FDA. The amounts of the three solvents in our routine 2-[(18)F]FDG products have been found well below the maximum permissible levels. The method is very amenable to quality control testing for the radiopharmaceutical.
authors.affiliation: PET Department, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA.
authors.forename: M A
authors.initials: MA
authors.lastname: Channing
authors.forename: B X
authors.initials: BX
authors.lastname: Huang
authors.forename: W C
authors.initials: WC
authors.lastname: Eckelman
mesh_terms: D002138:Calibration; D002849:Chromatography, Gas; D019788:Fluorodeoxyglucose F18 / Q000032:analysis*; D019275:Radiopharmaceuticals / Q000032:analysis*; D015203:Reproducibility of Results; D012997:Solvents / Q000032:analysis
chemical_list: D019275:Radiopharmaceuticals; D012997:Solvents; D019788:Fluorodeoxyglucose F18