Klok Robert P, Windhorst Albert D
Nuclear Medicine and PET Research, VU University Medical Center, 1081 HV Amsterdam, The Netherlands.
Nucl Med Biol. 2006 Oct;33(7):935-8. doi: 10.1016/j.nucmedbio.2006.07.003.
For the detection and quantification of residual solvents in solutions of radiopharmaceuticals for human applications, a new analysis method was set up. With a simple direct gas chromatography injection, no special sample treatments or special injection techniques (such as head-space or solid-phase microextraction) are necessary. This method is especially suited for the fast and quantitative analysis of residual solvents in radiopharmaceutical formulations where 5-12% ethanol is present. The method proved to be both accurate and linear. The quantification limit is in the lower parts-per-million range, which is sufficient given the need for a fast analysis and the maximally allowed concentration for these residual solvents.
为检测和定量分析用于人类的放射性药物溶液中的残留溶剂，建立了一种新的分析方法。通过简单的直接气相色谱进样，无需特殊的样品处理或特殊进样技术（如顶空或固相微萃取）。该方法特别适用于快速定量分析含有5-12%乙醇的放射性药物制剂中的残留溶剂。该方法经证明具有准确性和线性。定量限处于百万分之几的较低范围，鉴于快速分析的需求以及这些残留溶剂的最大允许浓度，这已足够。
