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

Nucl Med Biol. 2006 Oct;33(7):935-8. doi: 10.1016/j.nucmedbio.2006.07.003.

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.

MeSH terms

  • Chemistry, Pharmaceutical
  • Chromatography, Gas / methods*
  • Ethanol / analysis*
  • Ethanol / chemistry*
  • Radiopharmaceuticals / analysis*
  • Radiopharmaceuticals / chemistry*
  • Solvents / analysis*
  • Solvents / chemistry*

Substances

  • Radiopharmaceuticals
  • Solvents
  • Ethanol