气相色谱法对^(18)F-FDG中有机溶剂残留的测定  

Analysis of Residual Solvents in ^(18)F-FDG by Gas Chromatography

作　　者：何山震[1] 王淑侠[1] 陈立光[1] 王朋[1] 

机构地区：[1]广东省人民医院PET中心,广东广州510080

出　　处：《同位素》2008年第1期58-60,64,共4页Journal of Isotopes

摘　　要：以SPB-5型毛细管柱作为分离柱,采用气相色谱法对PET示踪剂2-18F-2-脱氧-D-葡萄糖(18F-FDG)合成工艺中所使用的有机溶剂乙腈、乙醇及丙酮进行了检测。结果表明,气相色谱法在10 min内可有效分离并定量检测有机溶剂乙腈、乙醇及丙酮的残留量。采用此方法检测了5批次18F-FDG产品,检测结果显示,18F-FDG中含乙腈0.097 g/L、乙醇0.120 g/L、丙酮0.165 g/L,均低于美国药典的要求。该方法具有良好的重复性,并且分析准确、迅速,适合18F-FDG中乙腈、乙醇和丙酮残留物的快速、定量测定。A conventional gas chromatography method was developed for the measurement of the residual acetonitrile, ethanol and acetone in 2-^18 F-fluoro-2-deoxy-D-glucose （^18F- FDG） injection. The three solvents were separated on SPB-5 column with FID detetor, and the temperature of column, detector and oven was 60℃, 150℃ and 150 ℃, respectively. Under the condition, the residual solvents of acetonitrile,ethanol and acetone could be separated effectively, excellent linearity was obtained over the range of 0. 10 g/L to 2.00 g/L, the R of the standard curve was 0. 999 8, 0. 999 1, 0. 998 9 respectively. The amounts of the three solvents in ^18F-FDG products were found well below the maximum permissible levels（acetonitrile less than 0.04% and ethanol less than 0.5% ）. The method is suitable for the analysis of the residual acetonitrile, ethanlo and acetone in ^18F-FDG injection.

关 键 词：^18F—FDG 气相色谱法(Gc) 有机残留量 

分 类 号：TQ463[化学工程—制药化工] O657.7[理学—分析化学]