The Korean Journal of Nuclear Medicine Technology (핵의학기술)
- Volume 15 Issue 2
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- Pages.26-29
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- 2011
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- 1229-9901(pISSN)
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- 2982-8406(eISSN)
Analysis of Residual Solvents of [F-18]FDG Using Gas Chromatography
기체크로마토그래프법을 이용한 [F-18]FDG의 잔류용매 분석
- Kim, Dong-Il (Department of Nuclear Medicine, Samsung Medical Center) ;
- Lee, Il-Jung (Department of Nuclear Medicine, Samsung Medical Center) ;
- Kim, Shi-Hwal (Department of Nuclear Medicine, Samsung Medical Center) ;
- Chi, Yong-Gi (Department of Nuclear Medicine, Samsung Medical Center) ;
- Seok, Jae-Dong (Department of Nuclear Medicine, Samsung Medical Center)
- Received : 2011.06.30
- Accepted : 2011.07.05
- Published : 2011.11.05
Abstract
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 (
[F-18]FDG 제조 후 품질관리를 수행하는데 있어서 품질관리 항목 중 잔류용매 시험은 최종 [F-18]FDG 바이알에 잔류하는 유기용매를 측정하기 위한 것이다. 본 연구는 자동합성장치에 따른 최종 [F-18]FDG 바이알에 잔류하는 유기용매의 종류를 파악하고, 잔류량을 측정하고자 하였다. 불꽃이온화 검출기(Flame Ionization Detector)가 장착된 기체크로마토그래프(Agilent Technologies 7890A)를 이용하여 제조 후 일주일 이내의 밀봉 바이알에 보관한 [F-18]FDG를 기체크로마토그래프에