基于固相萃取纯化的[F]FMISO一锅法改进制备：欧洲药典专论中报道的分析方法的缺陷
An improved one-pot preparation of [ F]FMISO based on solid phase extraction purification: Pitfalls on the analytical method reported in the Ph.Eur.'s monograph.
作者信息
Cucchi Claudio, Bogni Anna, Casanova Chiara, Seregni Ettore, Pascali Claudio
机构信息
IRCCS National Cancer Institute Foundation, Milan, Italy.
出版信息
J Labelled Comp Radiopharm. 2022 Jan;65(1):6-12. doi: 10.1002/jlcr.3954. Epub 2021 Oct 17.
By adapting previously reported reaction conditions, [ F]FMISO was synthesized using a TracerLab FX-FDG module in 31 min from no carrier added [ F]fluoride in 56% radiochemical yield. A novel and simple purification setup based on disposable cartridges was developed allowing the radiopharmaceutical to be obtained in high radiochemical purity (>99.5%) and with chemical impurities far below the Ph.Eur.'s thresholds. Moreover, the study pinpointed some shortcomings of the high-performance liquid chromatography (HPLC) method reported in the dedicated Ph.Eur's monograph.
通过采用先前报道的反应条件，使用TracerLab FX-FDG模块在31分钟内由无载体添加的[F]氟化物合成了[F]FMISO，放射化学产率为56%。开发了一种基于一次性柱盒的新颖且简单的纯化装置，使得能够获得放射化学纯度高（>99.5%）且化学杂质远低于欧洲药典阈值的放射性药物。此外，该研究指出了欧洲药典专论中报道的高效液相色谱（HPLC）方法的一些缺点。
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