Stability Evaluation of 18F-FDG at High Radioactive Concentrations
Stability Evaluation of 18F-FDG at High Radioactive Concentrations
复制标题
DOI：
10.2967/jnmt.111.097287
复制
发表时间：
2012-03-01
影响因子：
1.3
通讯作者：
Mosman, Elton A.
中科院分区：
文献类型：
--
作者：
Walters, Leah R.;Martin, Katherine J.;Mosman, Elton A.
我们研究的目的是确定乙醇的浓度，一种已知的辐射溶解稳定剂，在合成结束时（EOS）， F-18-FDG浓度为19.7-22.6 GBq/mL （533-610 mCi/mL）时，需要保持12 h的稳定性。方法：用16.5 mev质子在回旋加速器上与O-18(p, n)F-18反应生成F-18（-）。采用合成平台合成F-18-FDG。最终产物在15ml磷酸盐缓冲液中配制。合成时间为22分钟，在EOS上产生高达336.7 GBq （9.1 Ci）的F-18-FDG。完成了一系列9次运行，19.7-22.6 GBq/mL （533-610 mCi/mL）。3组添加0.1%乙醇，3组添加0.2%乙醇，3组不添加乙醇。放射化学纯度（RCP）在12小时的周期内以约1小时的增量进行测试。用铝背硅胶板、乙腈和水90:10的放射薄层色谱法发现RCP。使用1 mg/mL的F-18-FDG标准来确认放射化学身份。色谱板用8检测器在无线电薄层色谱仪上进行分析。残余溶剂也用气相色谱火焰电离检测和毛细管柱检测。其他质量控制测量包括pH值和外观。结果：掺0.1%乙醇的3组在5 h后RCP失败。掺0.2%乙醇的3组在超过EOS后12 h保持稳定。在这3次运行中，3小时后放射性溶解杂质相对稳定在6.1% +/- 0.7%。不使用乙醇的运行在1小时时RCP失败。pH在5.3和6.1之间变化。目视检查总是清晰无颗粒。当乙醇浓度为0.2%和0.1%时，溶剂残留量分别为0.21% +/- 0.02%和0.10% +/- 0.02%。无论乙醇浓度，化学纯度和鉴定通过质量控制测量。结论：添加0.2%乙醇时，F-18-FDG （19.7-22.6 GBq/mL [533-610 mCi/mL]）在EOS后12 h内保持稳定。每次运行通过与放射溶解相关的稳定性参数，即放射化学特性和RCP、化学纯度和特性、外观、pH和残留溶剂。
The objective of our study was to determine the concentration of ethanol, a known radiolytic stabilizer, needed to maintain stability for 12 hat an F-18-FDG concentration of 19.7-22.6 GBq/mL (533-610 mCi/mL) at the end of synthesis (EOS). Methods: F-18(-) was formed by the O-18(p, n)F-18 reaction using 16.5-MeV protons on a cyclotron. F-18-FDG was synthesized using a synthesis platform. The final product was formulated in 15 mL of phosphate buffer. The synthesis took 22 min, delivering up to 336.7 GBq (9.1 Ci) of F-18-FDG at the EOS. A series of 9 runs, 19.7-22.6 GBq/mL (533-610 mCi/mL), was completed. Three runs were doped with 0.1% ethanol, 3 with 0.2% ethanol, and 3 with no ethanol added. The radiochemical purity (RCP) was tested at about 1-h increments over a 12-h period. RCP was found by radio-thin-layer chromatography using aluminum-backed silica gel plates, acetonitrile, and water 90:10. An F-18-FDG standard of 1 mg/mL was used to confirm radiochemical identity. The chromatography plates were analyzed on a radio-thin-layer chromatograph using a 8-detector. Residual solvents were also tested using gas chromatography with flame ionization detection and a capillary column. Other quality control measurements performed were pH and appearance. Results: The 3 runs doped with 0.1% ethanol failed RCP after 5 h. The 3 runs using an ethanol concentration of 0.2% maintained stability through 12 h beyond the EOS. For these 3 runs, the radiolytic impurities were relatively constant at 6.1% +/- 0.7% after 3 h. The runs using no ethanol failed RCP at 1 h. The pH varied between 5.3 and 6.1. Visual inspection was always clear and particulate-free. For the runs with 0.2% and 0.1% ethanol, the residual solvents were 0.21% +/- 0.02% and 0.10% +/- 0.02%, respectively. Regardless of ethanol concentration, chemical purity and identity passed quality control measurements. Conclusion: With the addition of 0.2% ethanol, F-18-FDG (19.7-22.6 GBq/mL [533-610 mCi/mL]) kept stability through 12 h beyond the EOS. Each run passed stability parameters related to radiolysis-that is, radiochemical identity and RCP, chemical purity and identity, appearance, pH, and residual solvents.