open access

Vol 19, No 1 (2014)
Supplement Papers
Published online: 2014-01-01
Submitted: 2013-09-16
Get Citation

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

Krzysztof Kilian, Bartłomiej Chabecki, Justyna Kiec, Agnieszka Kunka, Barbara Panas, Maciej Wójcik, Anna Pękal
DOI: 10.1016/j.rpor.2014.03.001
·
Rep Pract Oncol Radiother 2014;19(1).

open access

Vol 19, No 1 (2014)
Supplement Papers
Published online: 2014-01-01
Submitted: 2013-09-16

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.

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.

Get Citation

Keywords

[[ce:sup loc=" pre" ]]18FDG; Radionuclidic impurities; Radiopharmaceuticals; Gamma-spectrometry

About this article
Title

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

Journal

Reports of Practical Oncology and Radiotherapy

Issue

Vol 19, No 1 (2014)

Published online

2014-01-01

DOI

10.1016/j.rpor.2014.03.001

Bibliographic record

Rep Pract Oncol Radiother 2014;19(1).

Keywords

[[ce:sup loc="pre"]]18FDG
Radionuclidic impurities
Radiopharmaceuticals
Gamma-spectrometry

Authors

Krzysztof Kilian
Bartłomiej Chabecki
Justyna Kiec
Agnieszka Kunka
Barbara Panas
Maciej Wójcik
Anna Pękal

Important: This website uses cookies. More >>

The cookies allow us to identify your computer and find out details about your last visit. They remembering whether you've visited the site before, so that you remain logged in - or to help us work out how many new website visitors we get each month. Most internet browsers accept cookies automatically, but you can change the settings of your browser to erase cookies or prevent automatic acceptance if you prefer.

By "Via Medica sp. z o.o." sp.k., ul. Świętokrzyska 73, 80–180 Gdańsk, Poland
tel.:+48 58 320 94 94, fax:+48 58 320 94 60, e-mail: journals@viamedica.pl