Stability evaluation of [ 18 F]FDG: literature study, stability studies from two diferent PET centres and future recommendations Jes G. Holler 1 , Børge Renmælmo 2 and Richard Fjellaksel 3* Background Tere is a need for an [ 18 F]FDG stability evaluation guide/checklist for radiopharmaceu- tical production sites. [ 18 F]FDG has been adopted worldwide as the most widely used clinical positron emission tomography (PET) radiotracer since the frst in human PET imaging in 1976 (Hess et al. 1976). Tere are several stability studies available. Hung (2002) compares diferent quality tests and demands in the United States Pharmaco- peia) USP/European Pharmacopeia (Ph. Eur.)/Te draft Chemistry, Manufacturing, and Controls (CMC) issued by the U.S. Food and Drug Administration (FDA) and Yu (2006) uses BP (British Pharmacopeia) as a quality reference standard (Hung 2002; Yu 2006). However, there is no review on updated stability evaluation based on available literature, recommendations and implementation for good manufacturing practice (GMP). Herein, we present a non-systematic literature study, stability studies of [ 18 F]FDG from two Abstract Background: The need for a stability evaluation of [ 18 F]FDG is evident. The main pur- pose 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 fnd the most relevant sta- bility data for [ 18 F]FDG. The amount of radioactivity, radio-stabilizers, choice of synthe- sis, 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. Conclusions: We have made recommendations for future stability evaluations based on our fndings. The most important fndings 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 [ 18 F]FDG stable. Keywords: [ 18 F]FDG, Stability, Quality control, Physiochemical aspects, Drug product development, Radiopharmaceutics, Pharmaceutics, Manufacturing process design Open Access © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the mate- rial. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creativecommons.org/licenses/by/4.0/. RESEARCH ARTICLE Holler et al. EJNMMI Radiopharmacy and Chemistry (2022) 7:2 https://doi.org/10.1186/s41181-022-00154-3 EJNMMI Radiopharmacy and Chemistry *Correspondence: Richard.fellaksel@uit.no 3 Department of Health and Care Sciences, UiT The Arctic University of Norway, Hansine Hansens veg 18, 9019 Tromsø, Norway Full list of author information is available at the end of the article