Rahmani Siyavash, Shahhoseini Soraya, Mohamadi Reza, Vojdani Mostafa
PET/CT Unit, Ferdous Nuclear Medicine Center, Dr Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Pharmaceutical Chemistry Department, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Iran J Pharm Res. 2017 Spring;16(2):602-610.
The introduction of 2-[F] fluor-2-deoxy-D-glucose (FDG) has provided a valuable tool for the study of glucose metabolism in both normal and diseased tissue in conjunction with positron emission tomography (PET). FDG is the most important radiopharmaceutical to be used in Nuclear Medicine for studying the brain, heart and tumor. The advancement in synthesis and quality control of FDG and its approval by US FDA are main reasons for increasing clinical application of FDG over the last 20 years. In this manuscript we explain the synthesis, quality control and stability studies of FDG (evaluate the physicochemical and microbiological stability of FDG, stored at room temperature (18 - 23 °C), and 35 - 40 °C, at different time intervals). We investigated how the influence of environmental factors in different lengths of time, alters the quality of this radiopharmaceutical. The pH, radionuclidic identity and purity, radiochemical identity and purity, chemical purity, bacterial endotoxins and sterility of FDG were evaluated according to the European Pharmacopoeia 7ed. analytical methods and acceptance criteria. The results suggest that under experimental conditions FDG has physicochemical and microbiological stability up to 10 h after the end of synthesis.
2-[F]氟-2-脱氧-D-葡萄糖（FDG）的引入，结合正电子发射断层扫描（PET），为研究正常组织和病变组织中的葡萄糖代谢提供了一种有价值的工具。FDG是核医学中用于研究大脑、心脏和肿瘤的最重要的放射性药物。FDG合成与质量控制方面的进展及其获得美国食品药品监督管理局（FDA）的批准，是过去20年中FDG临床应用不断增加的主要原因。在本手稿中，我们阐述了FDG的合成、质量控制和稳定性研究（评估在室温（18 - 23°C）以及35 - 40°C下，不同时间间隔储存的FDG的物理化学和微生物稳定性）。我们研究了不同时长的环境因素影响如何改变这种放射性药物的质量。根据欧洲药典第7版的分析方法和验收标准，对FDG的pH值、放射性核素特性与纯度、放射化学特性与纯度、化学纯度、细菌内毒素和无菌性进行了评估。结果表明，在实验条件下，FDG在合成结束后长达10小时具有物理化学和微生物稳定性。
