18F-FDG Production and Quality Control: An Overview

Abstract: 18F–FDG is a glucose analogue in which the hydroxyl group on the 2–carbon of a glucose molecule is replaced by a fluoride atom and 18F-FDG PET scanning has been used in clinical cancer diagnostics since the 1990s. 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 flourish of clinical PET over the last 30 years. This review covers 18F-FDG practical synthesis as well as quality control requirements including radionuclidic identity, radiochemical purity, chemical purity, pH, residual solvent, sterility, bacterial endotoxin level and filter membrane integrity test