[en] A gas chromatography method has been developed for the measurement of the residual acetone, ethanol and acetonitrile in 2-deoxy-2-[¹⁸F] fluoro-D-glucose (2-[¹⁸F]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-[¹⁸F]FDG products have been found well below the maximum permissible levels. The method is very amenable to quality control testing for the radiopharmaceutical

[en] A high-performance liquid chromatography-tandem mass spectrometric method (LC/MS/MS) was developed and validated for the quantitative analysis of Kryptofix (K-222) in the radiopharmaceuticals of 2-deoxy-2-[¹⁸F] fluoro-D-glucose (2-[¹⁸F]FDG) and 3-(3-((3-fluoropropyl)thio)-1,2,5-thiadiazol-4-yl)-1,2,5,6-tetrahydro -1-methylpyridine (FPTZTP). With an internal standard, the limit of quantitation for K-222 was 1.0 ng/ml. This is so far the most sensitive method for the quantification of K-222. Excellent linearity (RSQ=0.9997) was obtained over the range of 1.0-100 ng/ml. Good precision and accuracy were also observed. The method is amenable to the validation of radiosynthetic methods

[en] Recycling of [¹⁸O]water for [¹⁸F]fluoride production can be accomplished with reliable results. We have developed sensitive, robust, and rapid analyses of impurities in [¹⁸O]water. Anions were quantitated by capillary electrophoresis and organic residuals were quantitated by gas chromatography using methods with excellent reproducibility and linearity. Kryptofix 222 (K-222) was quantitated by a sensitive LC-MS-MS technique. Isotopic composition was determined by GC-MS with satisfactory accuracy and precision. These methods were employed to evaluate recovered [¹⁸O]water purified by a novel electrolysis method. 2-[¹⁸F]FDG yields using purified [¹⁸O]water with very low levels of impurities are indistinguishable from newly purchased [¹⁸O]water. High (> 300 ppm) carbonate concentration reduces the fluoride trapping efficiency of QMA. The analyses of anions, organics, and isotopic enrichment were applied routinely for quality control of [¹⁸O]water to predict a satisfactory outcome of 2-[¹⁸F]FDG production