Residual solvent analysis by gas chromatography in radiopharmaceutical formulations containing up to 12% ethanol

Robert P. Klok*, Albert D. Windhorst

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)935-938
Number of pages4
JournalNuclear Medicine and Biology
Volume33
Issue number7
DOIs
Publication statusPublished - 1 Oct 2006

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