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

Abstract

Aim

The 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.

Background

For radiopharmaceuticals the general requirements are listed in European Pharmacopeia and these parameters have to be checked before application for human use.

Materials and methods

Standard 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.

Results

Results 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.

Conclusions

Produced ¹⁸FDG filled requirements of Ph.Eur. and the content of radionuclidic and metallic impurities was in the acceptable range.