기체크로마토그래프법을 이용한 [F-18]FDG의 잔류용매 분석

• 영문명: Analysis of Residual Solvents of [F-18]FDG Using Gas Chromatography
• 발행기관: 대한핵의학기술학회
• 저자명: 김동일(Dong Il Kim) 이일중(Il Jung Lee) 김시활(Shi Hwal Kim) 지용기(Yong Gi Chi) 석재동(Jae Dong Seok)
• 간행물 정보: 『핵의학기술』Vol.15 No.2, 26~29쪽, 전체 4쪽
• 주제분류: 의약학 > 방사선과학
• 파일형태: PDF
• 발행일자: 2011.11.30

영문 초록

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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실험 재료 및 방법

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키워드

Gas chromatography Solvent residue [F-18]FDG Acetic acid