Assessment of Aminopolyether on 18F-FDG Samples
The quality control procedures of a radiopharmaceutical include the assessment of its chemical purity. The method suggested by international pharmacopeias consists of a thin layer chromatographic run. In this paper, the method proposed by the United States Pharmacopeia (USP) is compared to a direct method to determine the final concentration of aminopolyether in Fludeoxyglucose (18F-FDG) preparations. The approach (no chromatographic run) was achieved by placing the thin-layer chromatography (TLC) plate directly on an iodine vapor chamber. Both methods were validated and they showed adequate results to determine the concentration of aminopolyether in 18F-FDG preparations. However, the direct method is more sensitive, faster and simpler when compared to the reference method (with chromatographic run), and it may be chosen for use in routine quality control of 18F-FDG.
Digital Object Identifier (DOI): doi.org/10.5281/zenodo.3462085Procedia APA BibTeX Chicago EndNote Harvard JSON MLA RIS XML ISO 690 PDF Downloads 205
 Fowler, J.S.; Ido, T. Initial and Subsequent Approach for the Synthesis of 18FDG. Seminars in Nuclear Medicine, 32(1),6-12, 2002.
 Nakao, R., Kida, T., Suzuki, K. Factors affecting quality control of 18FFDG injection: bacterial endotoxins test, aluminum ions test and HPLC analysis for FDG and ClDG. Applied Radiation and Isotopes, 62, 889-895, 2005.
 Yu, S. Review of 18F-FDG synthesis and quality control. Biomedical Imaging and Intervention Journal, 2(4), 1-11, 2006.
 Hoh, C.K. Clinical use of FDG PET. Nuclear Medicine and Biology, 34(7), 737-742, 2007.
 United States Pharmacopeia Convention - USP. 33th ed. Rockville: United States Pharmacopeial Convention, 2010.
 European Pharmacopeia – EP. 7th ed. London: Stationery Office, 2010.
 ANVISA. Resolução da Diretoria Colegiada - RDC n°. 166, 24 de julho de 2017.
 Food and Drugs Administration (FDA). Guidance for industry: Analytical procedures and methods validation, Ago. 2000.
 ICH- Internacional Conference on Harmonisation. Guidance for Industry Q2B. Test on Validation of Analytical Procedures. Nov., 1996.