Abstract
BackgroundThe 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.ResultsWe 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.ConclusionsWe 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.
Highlights
The need for a stability evaluation of [18F]FDG is evident
The most important findings 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
There is a need for an [18F]FDG stability evaluation guide/checklist for radiopharmaceutical production sites. [18F]FDG has been adopted worldwide as the most widely used clinical positron emission tomography (PET) radiotracer since the first in human PET
Summary
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. There is a need for an [18F]FDG stability evaluation guide/checklist for radiopharmaceutical production sites. Hung (2002) compares different quality tests and demands in the United States Pharmacopeia) USP/European Pharmacopeia (Ph. Eur.)/The draft Chemistry, Manufacturing, and Controls (CMC) issued by the U.S Food and Drug Administration (FDA) and Yu (2006). There is no review on updated stability evaluation based on available literature, recommendations and implementation for good manufacturing practice (GMP). We present a non-systematic literature study, stability studies of [18F]FDG from two Holler et al EJNMMI Radiopharmacy and Chemistry (2022) 7:2 different PET centres and our recommendations for future [18F]FDG implementations for radiopharmaceutical production sites
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