title: Residual solvent analysis by gas chromatography in radiopharmaceutical formulations containing up to 12% ethanol.
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.
authors.affiliation: Nuclear Medicine and PET Research, VU University Medical Center, 1081 HV Amsterdam, The Netherlands. rklok@rnc.vu.nl
authors.forename: Robert P
authors.initials: RP
authors.lastname: Klok
authors.forename: Albert D
authors.initials: AD
authors.lastname: Windhorst
mesh_terms: D002626:Chemistry, Pharmaceutical; D002849:Chromatography, Gas / Q000379:methods*; D000431:Ethanol / Q000032:analysis* / Q000737:chemistry*; D019275:Radiopharmaceuticals / Q000032:analysis* / Q000737:chemistry*; D012997:Solvents / Q000032:analysis* / Q000737:chemistry*
chemical_list: D019275:Radiopharmaceuticals; D012997:Solvents; D000431:Ethanol