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

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.<p> <p>Results: We performed a non-systematic literature study to fnd 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 defned acceptance criteria were met. <p>Conclusions: We have made recommendations for future stability evaluations based on our fndings. The most important fndings were that the amount of the radiostabilizer 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.