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

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.