Synthesis, quality control and determination of metallic impurities in F-fludeoxyglucose production process

AimThe aim of this study was to synthesize 18FDG in some consecutive runs and check the quality of manufactured radiopharmaceuticals and to determine the distribution of metallic impurities in the synthesis process.BackgroundFor radiopharmaceuticals the general requirements are listed in European Pharmacopeia and these parameters have to be checked before application for human use.Materials and methodsStandard methods for the determination of basic characteristics of radiopharmaceuticals were used. Additionally, high resolution γ spectrometry was used for the assessment of nuclidic purity and inductively coupled plasma with mass spectrometry to evaluate metallic content.ResultsResults showed sources and distribution of metallic and radiometallic impurities in the production process. Main part is trapped in the initial separation column of the synthesis unit and is not distributed to the final product in significant amounts.ConclusionsProduced 18FDG filled requirements of Ph.Eur. and the content of radionuclidic and metallic impurities was in the acceptable range

Synthesis of 11C-methionine through gas phase iodination using Synthra MeIPlus synthesis module

A method of 11C-methionine synthesis using ‘bubbling’ method is presented. 11C-methionine was synthesized via 11C methylation from L-cysteine thiolactone (2 mg) in a 300 μL solution of 2:1:1 (v/v) 1 M NaOH, ethanol, and water at ambient temperature (85°C, 5 min). The radiochemical purity of radiotracer was higher than 99% and enantiomeric purity (L-11C-methionine) was 91.6 ± 0.4%. The final product met the requirements of European Pharmacopoeia monograph. The proposed 11C-methionine synthesis is a reliable tool for routine manufacturing in clinical applications and animal studies