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KMID : 0861420110150020026
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Korean Journal of Nuclear Medicine Technology
2011 Volume.15 No. 2 p.26 ~ p.29
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Analysis of Residual Solvents of [F-18]FDG Using Gas Chromatography
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Kim Dong-Il
Lee Il-Jung
Kim Si-Hwal
Ji Yong-Gi
Seok Jae-Dong
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Abstract
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Purpose:The general test method of the Korean Pharmacopeia specifies the test method on the clauses of quality
control after manufacturing. According to KFDA Guidance for Medicines, standards of residual solvents
regulates the maximum permissible dose of acetonitrile as 400 ppm, ethanol as 5,000 ppm, and acetic acid as
5,000 ppm. This study aims at identifying the type of resiual solvents in the final [F-18]FDG vial of an automatic
synthesizer and measure its residual quantity.
Materials and Methods: The center carried out residual solvents
test of [F-18]FDG injection using Agilent Technologies 7890A with a Flame Ionization Detector. The column of
Agilent Technologies 7890A used in measuring of residual solvents was CP WAX column (30 ｍ × 0.53 mm ×
1.0 μm) and analysis condition was split mode 1:1 at the initial temperature 70 oC which was increased
20oC/minute after two minutes and maintained at the final 140 oC for two minutes. The analysis method was as
following: Firstly, ethanol-acetonitrile-acetic acid mixture was classified into four types of concentration
(250-25-250 ppm, 1,000-100-1,000 ppm, 3,000-300-3,000 ppm, and 6,000-600-6,000 ppm), and 1.0 μL of each
type of concentration was injected into gas chromatography followed by an analysis of its peak domain. Then, a
calibration-curve by the external standard method was drawn based on the analysis result.
Results:While ethanol and acetonitrile were detected in TRACERlab MX, FASTlab had additional acetic acid. The residual quantity of the ethanol-acetonitrile-acetic acid mixture evaluated using the calibration-curve was average 72
ppm ethanol, 54 ppm acetonitrile, and 1030 ppm acetic acid for FASTlab, whereas average 439 ppm ethanol and
79 ppm acetonitrile for TRACERlab MX. This indicated that both of them were within the maximum
permissible dose.
Conclusion:Solvent residues in the [F-18]FDG injection were all within maximum
permissible doses and proper to be used to examine a patient. The result indicated that types and quantities of
solvent resides of radioactive pharmaceuticals vary depending on the automatic synthesizer.
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KEYWORD
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Gas chromatography, Solvent residue, [F-18]FDG, Acetic acid
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