McKay B F, Zimmer A M, Spies S M
Department of Nuclear Medicine, Northwestern University Medical Center, Chicago, Illinois, USA.
J Nucl Med Technol. 1997 Mar;25(1):52-4.
The purpose of this investigation was to develop and evaluate a new and rapid miniaturized chromatography system that would accurately assess the radiochemical purity of 99mTc-tetrofosmin without the problems of solvent ratios and time requirements associated with the manufacturer's recommended procedure.
The migration of the radiochemical components of 99mTc-tetrofosmin was evaluated using various chromatography media with ethyl acetate as the solvent. After optimization of the miniaturized system, radiochemical purity assessments were performed simultaneously on 23 99mTc-tetrofosmin preparations using both recommended and miniaturized chromatography systems.
A miniaturized chromatography system consisting of Whatman 1 chromatography paper with ethyl acetate was developed for the radiochemical purity assessment of 99mTc-tetrofosmin. Radiochemical purity results for 99mTc-tetrofosmin preparations were similar with both recommended and miniaturized chromatography methods, with a mean difference of 1.5% +/- 1.2% (s.d.). Differences in radiochemical purity results between the two chromatography systems were less than 2% (20 of 23 evaluations) with most preparations.
Radiochemical purity results for 99mTc-tetrofosmin preparations were similar with both the manufacturer's recommended chromatography and miniaturized chromatography systems. The miniaturized chromatography system is easier to use, and the time required to perform radiochemical purity assessments is substantially reduced.
本研究的目的是开发并评估一种新型快速小型化色谱系统，该系统能够准确评估99mTc-替曲膦的放射化学纯度，且不存在与制造商推荐方法相关的溶剂比例和时间要求问题。
以乙酸乙酯为溶剂，使用各种色谱介质评估99mTc-替曲膦放射化学组分的迁移情况。在优化小型化系统后，使用推荐的色谱系统和小型化色谱系统同时对23份99mTc-替曲膦制剂进行放射化学纯度评估。
开发了一种由Whatman 1色谱纸和乙酸乙酯组成的小型化色谱系统，用于99mTc-替曲膦的放射化学纯度评估。99mTc-替曲膦制剂的放射化学纯度结果在推荐的色谱方法和小型化色谱方法中相似，平均差异为1.5%±1.2%（标准差）。大多数制剂在两种色谱系统之间的放射化学纯度结果差异小于2%（23次评估中的20次）。
99mTc-替曲膦制剂的放射化学纯度结果在制造商推荐的色谱系统和小型化色谱系统中相似。小型化色谱系统更易于使用，且进行放射化学纯度评估所需的时间大幅减少。
