Holler Jes G, Renmælmo Børge, Fjellaksel Richard
Department of Nuclear Medicine, The PET Imaging Centre, University Hospital of Central Norway, Ragnhilds gate 15, 7030, Trondheim, Norway.
The PET Imaging Centre, University Hospital of North Norway, Hansine Hansens veg 82, 9019, Tromsø, Norway.
EJNMMI Radiopharm Chem. 2022 Feb 24;7(1):2. doi: 10.1186/s41181-022-00154-3.
The need for a stability evaluation of [F]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.
We performed a non-systematic literature study to find the most relevant stability data for [F]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.
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 [F]FDG stable.
对[F]FDG进行稳定性评估的需求显而易见。本研究的主要目的是根据现有的稳定性文献以及我们自己的双中心稳定性研究，为确定保质期提出建议。
我们进行了一项非系统性文献研究，以找到与[F]FDG最相关的稳定性数据。放射性量、放射性稳定剂、合成方法的选择、稀释、pH值、温度、储存以及稳定性测试和验收标准的选择是实施良好生产规范时需要评估的最重要因素。此外，我们讨论了该研究的一些局限性，特别是合成方法的选择、光稳定性、环境、温度和储存。基于这些数据，我们设计了自己的双中心稳定性研究。所有规定的验收标准均得到满足。
我们根据研究结果为未来的稳定性评估提出了建议。最重要的发现是，对于活度高达4GBq/mL的情况，放射性稳定剂乙醇的量应>0.1%乙醇；对于活度高达22.7GBq/mL的情况，放射性稳定剂乙醇的量应>0.2%乙醇，以保持[F]FDG的稳定性。
