Synthesis and quality control of 18F-FDG at IPEN-CNEN/SP

There is an increasing interest in 18F-radiopharmaceuticals especially in 18F-FDG, which is used in Nuclear Medicine for brain, heart and tumor studies. This report describes the routine production and quality control of 18F-FDG at IPEN-CNEN/SP. The 18F- (fluoride) is obtained by the nuclear reaction 18O (p,n) 18F in the Cyclone-30 (IBA), using 2 ml of enriched H218O (95.2 %). After [18F-] fluoride retention in QMA light filter (Waters) and recovery as 18FK in 0.3 ml of K2CO3 and H2O, the synthesis is achieved by a nucleophilic substitution of mannose triflate reaction in the automatic module (IBA) followed by an evaporation of the organic solvent in a heated vessel. After hydrolysis under acid medium, the final product is purified by anionic resin, Alumine and C18 cartridges and sterilized by 0.22 μm Millipore filter. The resulting neutral eluent is dispensing in a sterile glass vial containing 1.5 ml of pH 7.5 buffer phosphate. The enriched water used in the production is recycled after distillation. Thin layer chromatography system was carried out for radiochemical and chemical determination, in ITLC-SG (AL) (2x10 cm), using acetonitrile:H2O (95:5) and NH4OH: MeOH (1:9) as solvents, respectively. Sterility and pyrogen tests were performed by the microbiology procedures outlined in the pharmacopoeias and by the 'in-vitro' Limulus test, respectively. In more than 80 productions during 2001, the Radiopharmacy Center has produced 18,500 MBq/batch of 18F-FDG (EOS). About 98% of the activity were recovered in the QMA filter and the radiochemical and radionuclide purities of 18F-FDG were better than 97%. The Kriptofix level was below of the detection limit of color spot test. From our experience, the recovery of [18O] water by distillation is very convenient and economical and can be used for further production of 18F-