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Quality Control of Residual Solvents in $[^{18}F]$FDG Preparations by Gas Chromatography  

Lee, Hak-Jeong (Department of Nuclear Medicine, College of Medicine and Institute of Radiation Medicine, Medical Research Center, Seoul National University)
Jeong, Jae-Min (Department of Nuclear Medicine, College of Medicine and Institute of Radiation Medicine, Medical Research Center, Seoul National University)
Lee, Yun-Sang (Department of Nuclear Medicine, College of Medicine and Institute of Radiation Medicine, Medical Research Center, Seoul National University)
Kim, Hyung-Woo (Department of Nuclear Medicine, College of Medicine and Institute of Radiation Medicine, Medical Research Center, Seoul National University)
Chang, Young-Soo (Department of Nuclear Medicine, College of Medicine and Institute of Radiation Medicine, Medical Research Center, Seoul National University)
Lee, Dong-Soo (Department of Nuclear Medicine, College of Medicine and Institute of Radiation Medicine, Medical Research Center, Seoul National University)
Chung, June-Key (Department of Nuclear Medicine, College of Medicine and Institute of Radiation Medicine, Medical Research Center, Seoul National University)
Lee, Myung-Chul (Department of Nuclear Medicine, College of Medicine and Institute of Radiation Medicine, Medical Research Center, Seoul National University)
Publication Information
Nuclear Medicine and Molecular Imaging / v.41, no.6, 2007 , pp. 566-569 More about this Journal
Abstract
Purpose: Analysis of volatile organic solvents in 2-deoxy-2-$[^{18}F]$ fluoro-D-glucose ($[^{18}F]$FDG) preparations was performed by gas chromatography (GC), in accordance with USP. Materials and Methods: Analyses were carried out on a Hewlett-Packard 6890 gas chromatography equipped with an FID. Results: We determined the amounts of ethanol and acetonitrile on every batch of our routine $[^{18}F]$FDG preparations, ranging between 5000 ppm and 100 ppm. In our routine preparation of $[^{18}F]$FDG, the amount of acetonitrile and ethanol in the final product were well below the maximum allowable limit described in the USP. Conclusion: Our $[^{18}F]$FDG preparations were in accordance with the suggested USP maximum allowable levels of the quality control analysis of volatile organic compounds.
Keywords
residual solvents$[^{18}F]$; FDG; gas chromatography; quality control;
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1 Alexoff DL, Casati R, Fowler JS, Wolf AP, Shea C, Schlyer DJ, et al. Ion Chromatographic Analysis of High Specific Activity $^{18}$FDG Preparations and Detection of the Chemical Impurity 2-Deoxy-2-chloro-D-glucose. Appl Radiat Isot 1992;43:1313-22   DOI   ScienceOn
2 Ferrieri RA, Schlyer DJ, Alexoff DL, Fowler JS, Wolf AP, Direct Analysis of Kryptofix 2.2.2 in $^{18}$FDG by Gas Chromatography Using a Nitrogen-selective Detector. Nucl Med Biol 1993;20:367-9   DOI
3 Mock BH, Winkle W, Vavrek MT. A Color Spot Test for the Detection of Kryptofix 2.2.2 in [$^{18}$F]FDG Preparations. Nucl Med Biol 1997;24:193-5   DOI   ScienceOn
4 Hung JC. Comparison of Various requirements of the Quality Assurance procedures for $^{18}$F-FDG Injection. J Nucl Med. 2002;43: 1495-1506
5 Rockville, MD. Organic volatile impurities. (2000)The United States Pharmacopeia 24/National Formulary 19 The United States Pharmacopeial Convention
6 Hamacher K, Coenen HH, Stcklin G. Efficient Stereospecific Synthesis of No-Carrier-Added 2-[$^{18}$F]-Fluoro-2-Deoxy-D-Glucose Using Aminopolyether supported Nucleophilic Substitution, J Nucl Med 1986;27:235-8
7 Chang IL, Diubaldo D, Sanders WJ. Headspace Analysis of Organic Volatile Impurities in Bulk Pharmaceutical Chemicals. Hewlett-Packard Company, USA, 1994 Application Note 228-55
8 Classification of residual solvents by risk assessment. In: Guidance for Industry: Q3C Impurities-Residual Solvents. Rockville, MD: Food and Drug Administration; 1997:3 Available at: http://www.Fda.gov/cder/guidance/Q3Cfnl.pdf. Accessed August 14, 2002
9 Alexoff DL, Fowler JS, Gatley SJ. Removal of the 2.2.2 Cryptand (Kryptofix 2.2.2) from $^{18}$FDG by Cation Exchange. Appl Radiat Isot 1989;42:1189-93
10 Chaly T, Dahl JR. Thin layer Chromatographic Detection of Kryrtofix 2.2.2 in the Routine Synthesis of [$^{18}$F]2-Fluoro-2-deoxy- Dglucose. Nucl Med Biol 1989;16:385-7
11 Moerlein SM, Brodack JW, Siegel BA, Welch MJ. Elimination of Contaminant Kryptofix 2.2.2 in the Routine Production of 2-[$^{18}$F]Fluoro-2-deoxy-D-glucose. Appl Radiat Isot 1989;40:741-3   DOI   ScienceOn
12 Yu S. Review of $^{18}$F-FDG synthesis and Quality control. Biomed Imaging Interv J 2006;2(4):e57
13 Channing MA, Huang BX, Eckelman WC. Analysis of residual solvents in 2-[$^{18}$F]FDG by GC. Nucl Med Biol 2001;28:469-71   DOI   ScienceOn
14 Acetonitrile [material safety data sheet]. Thermo Fisher Scientific Inc. available USA at: http://fscimage.fishersci.com/msds/00170.html. Accessed June 19, 2007
15 Ethanol SDA1, Anhydrous [material safety data sheet]. Thermo Fisher Scientific Inc. USA. available at: http://fscimage.fishersci.com/msds/88067.html. Accessed June 19, 2007
16 The Merck Index 13th edition, An Encyclopedia of Chemicals, Drugs. And Biologicals. Maryadele J. O'Neil et al (Ed.). Whitehouse Station. Nj. Merck & Co., Inc. 2001