Analysis of residual solvents in 2-[F-18]FDG by GC

A gas chromatography method has been developed for the measurement of the r esidual acetone, ethanol and acetonitrile in 2-deoxy-2-[F-18] fluoro-D-gluc ose (2-[F-18]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 concentratio n levels proposed by FDA. The amounts of the three solvents in our routine 2-[F-18]FDG products have been found well below the maximum permissible lev els. The method is very amenable to quality control testing for the radioph armaceutical. (C) 2001 Elsevier Science Inc. All rights reserved.