Vol 19, No 1 (2014)
Supplement Papers
Published online: 2014-01-01

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

Krzysztof Kilian1, Bartłomiej Chabecki2, Justyna Kiec2, Agnieszka Kunka2, Barbara Panas2, Maciej Wójcik2, Anna Pękal1
DOI: 10.1016/j.rpor.2014.03.001
Rep Pract Oncol Radiother 2014;19(1).

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.

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Reports of Practical Oncology and Radiotherapy