18F-FDG SYNTHESIS AND QUALITY CONTROL AND COST EFFECTIVENESS IN NUCLEAR MEDICINE CENTER IN KHMC*

Abstract

The most widely used radiopharmaceutical in the expanding medical imaging technology of Positron Emission Tomography (PET) is 2-[18F]fluoro-2-deoxy-D-glucose (18FDG). The increasing demand for 18FDG requires reliable production in large amounts
In this article we will covers the fludeoxyglucose (18F-FDG) synthesis and quality control procedures and the cost effectiveness in KHMC with emphasis on practical synthesis currently; 18F-FDG is the most successful PET radiopharmaceutical so far.
It's started in Royal Medical Services in 2003 the advancement in synthesis and quality control of 18F-FDG, together with its approval by the US FDA and the availability of reimbursement, are probably the main reasons for the florin of clinical PET over the last 20 years. 18F-FDG can be synthesized by either electrophonic fluorination or nucleophilic fluorination reaction. Nucleophilic fluorination using mannose triflate as precursor and Kryptofix or tetrabutylammonium salts (TBA) is widely used because of higher yield and shorter reaction time.
The quality control requirements of 18F-FDG can be found in United States Pharmacopeia (USP), British Pharmacopeia (BP), European Pharmacopeia (EP) and the Chemistry, Manufacturing, and Controls (CMC) section from United States Food and Drug Administration (US FDA) PET draft guidance documents. Basic requirements include radionuclide identity, radiochemical purity, chemical purity, pH, residual solvent, sterility, and bacterial endotoxin level. Some of these tests (sterility, endotoxins and radionuclide purity) can be accomplished after the 18F-FDG has been released..