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| The comparison of the quality for 18F-FDG synthesized by two kind of FDG modules |
| ZHOU Wenshan1, DENG Pengyi2 |
1. Hubei Provincial Centre of Disease Control and prevention. Department of Nuclear Medicine, Wuhan 430000 China;
2. The First College of Clinical Medical Science, China Three Gorges University;Yichang Key Laboratory of Nuclear Medicine and Molecular Image |
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Abstract Objective To compare the quality of 18F-FDG synthesized by Sumitomo F300E module and domestic PET-FDG-IT-N modules which used different synthesis progress.Methods 18F-FDG samples synthesized by the two modules were randomly chose and the quality of the 18F-FDG samples was determined according to the method stipulated in the Chinese Pharmacopoeia 2015. The pH values of samples were measured by precision pH test paper. The radiochemical purities of samples were measured by thin layer chromatography. The amino polyether (K2.2.2) concentrations chloroplatinic acid indicator strips. The organic solvents concentrations of samples were measured by gas chromatography.Results All indicators of 18F-FDG samples synthesized by both Sumitomo F300E and domestic PET-FDG-IT-N modules fitted the standard of Chinese Pharmacopoeia (version 2015). The pH values of samples were about 6.0~6.5 (standard value:5.0~8.0). The radiochemical purities of all samples were above 99% (standard value: ≥ 90%). The residue of K2.2.2 was significantly lower than the standard of 50 g/mL. The average residue of acetonitrile(g/mL) synthesized by the two modules were (0.014±0.003)% and (0.016±0.003%), respectively, and there was no statistical difference (P=0.39) and the standard was below 0.0041%. The average residue of ethanol (g/mL) of samples synthesized by F300E module was (0.101±0.016)%, which was higher than samples synthesized by PET-FDG-IT-N module (0.023±0.016)%, g/mL, P=0.000). However, the ethanol concentrations of all samples were fitted standard (<0.5%). Acetone residues were not detected in all samples.Conclusion Although synthesis processes of the two modules were different, the quality of 18F-FDG synthesized by them fitted the Chinese Pharmacopoeia standard of 2015 edition.
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Received: 03 June 2018
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