氟代脱氧葡萄糖生产过程中金属杂质的合成、质量控制与测定
Synthesis, quality control and determination of metallic impurities in F-fludeoxyglucose production process.
作者信息
Kilian Krzysztof, Chabecki Bartłomiej, Kiec Justyna, Kunka Agnieszka, Panas Barbara, Wójcik Maciej, Pękal Anna
机构信息
University of Warsaw, Heavy Ion Laboratory, Pasteur 5a, 02-093 Warsaw, Poland.
University of Warsaw, Department of Physics, Hoża 69, 00-681 Warsaw, Poland.
出版信息
Rep Pract Oncol Radiother. 2014 Apr 16;19(Suppl):S22-S31. doi: 10.1016/j.rpor.2014.03.001. eCollection 2014 May.
AIM
The aim of this study was to synthesize FDG in some consecutive runs and check the quality of manufactured radiopharmaceuticals and to determine the distribution of metallic impurities in the synthesis process.
BACKGROUND
For radiopharmaceuticals the general requirements are listed in European Pharmacopeia and these parameters have to be checked before application for human use.
MATERIALS AND METHODS
Standard methods for the determination of basic characteristics of radiopharmaceuticals were used. Additionally, high resolution γ spectrometry was used for the assessment of nuclidic purity and inductively coupled plasma with mass spectrometry to evaluate metallic content.
RESULTS
Results showed sources and distribution of metallic and radiometallic impurities in the production process. Main part is trapped in the initial separation column of the synthesis unit and is not distributed to the final product in significant amounts.
CONCLUSIONS
Produced FDG filled requirements of Ph.Eur. and the content of radionuclidic and metallic impurities was in the acceptable range.
目的
本研究的目的是在连续多次运行中合成氟代脱氧葡萄糖（FDG），检查制备的放射性药物的质量，并确定合成过程中金属杂质的分布情况。
背景
对于放射性药物，欧洲药典列出了一般要求，在用于人体之前必须检查这些参数。
材料与方法
采用测定放射性药物基本特性的标准方法。此外，高分辨率γ能谱法用于评估核素纯度，电感耦合等离子体质谱法用于评估金属含量。
结果
结果显示了生产过程中金属和放射性金属杂质的来源及分布。主要部分被困在合成单元的初始分离柱中，不会大量分布到最终产品中。
结论
所生产的FDG符合欧洲药典的要求，放射性核素和金属杂质的含量在可接受范围内。
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