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

Nucl Med Biol

Nuclear Medicine and PET Research, VU University Medical Center, 1081 HV Amsterdam, The Netherlands.

Published: October 2006

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.

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http://dx.doi.org/10.1016/j.nucmedbio.2006.07.003DOI Listing

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