18F-FDG放射化学纯度分析方法的建立及方法不确定度的评定

建立了¹⁸F-FDG放射化学纯度的分析方法。以丙酮-水（体积比为50∶20）为展开剂，用2%KAlSO₄溶液处理的Whatman No.1纸为固定相， ¹⁸F^-的R_f＝0，¹⁸F-FDG的R_f＝0.78，方法的相对标准偏差小于1%。本方法简便、快速，适用于¹⁸F-FDG注射液的放射化学纯度分析。对放射化学纯度分析方法的不确定度进行了初步评定，本方法的扩展不确定度u＝0.199 1，u由合成不确定度u_c＝0.095 00及包含因子k＝2.096而得。

Establishment and Uncertainty Evaluation of Analytical Method for Radiochemical Purity of 18F-FDG

The analytical method of ¹⁸F-FDG radiochemical purity was established. The mixed solution of acetone-water (50∶20 (V/V)) was used as developing reagent. Whatman No. 1 paper pre-processed with 2% KAlSO₄ solution was used as stationary phase. The R_f values of ¹⁸F^- and ¹⁸F-FDG are 0 and 0.78, respectively. The relative standard deviation is less than 1%. This method is simple, rapid, and suitable for radiochemical purity analysis of ¹⁸F-FDG injection. The uncertainty of analysis method for the radiochemical purity was evaluated. The expanded uncertainty u of this method is 0.199 1, and u is derived from the synthesis uncertainty (u_c＝0.095 00) and the coverage factor (k＝2.096).