Stability evaluation of [18F]FDG: literature study, stability studies from two different PET centres and future recommendations

Abstract

Abstract Background The need for a stability evaluation of [18F]FDG is evident. The main purpose of this study was to make recommendations for determining the shelf life based on the available stability literature and our own two-centre stability studies. Results We performed a non-systematic literature study to find the most relevant stability data for [18F]FDG. The amount of radioactivity, radio-stabilizers, choice of synthesis, dilution, pH, temperature, storage and the choice of stability tests and acceptance criteria were the most important factors to evaluate for the implementation of good manufacturing practice. Moreover, we discuss some limitations of the study, especially the choice of synthesis, photostability, the environment, temperature and storage. Based on these data, we designed our own two-centre stability studies. All the defined acceptance criteria were met. Conclusions We have made recommendations for future stability evaluations based on our findings. The most important findings were that the amount of the radio-stabilizer ethanol should be > 0.1 % ethanol for activities up to 4 GBq/mL and > 0.2 % ethanol for activities up to 22.7 GBq/mL to keep [18F]FDG stable.

Keywords

• [18F]FDG
• Stability
• Quality control
• Physiochemical aspects
• Drug product development
• Radiopharmaceutics