Radiotracers labeled with carbon-11 (t_1/2 = 20.4 min) are widely used with positron emission tomography for biomedical research. Radiotracers must be produced for positron emission tomography studies in humans according to prescribed time schedules while also meeting current good manufacturing practice. Translation of an experimental radiosynthesis to a current good manufacturing practice environment is challenging. Here we exemplify such translation with a protocol for the production of an emerging radiotracer for imaging brain translocator protein 18 kDa, namely [¹¹C]ER176. This radiotracer is produced by rapid conversion of cyclotron-produced [¹¹C]carbon dioxide into [¹¹C]iodomethane, which is then used to treat N-desmethyl-ER176 in the presence of base (^tBuOK) at room temperature for 5 min. [¹¹C]ER176 is separated in high purity by reversed-phase HPLC and formulated for intravenous injection in sterile ethanol–saline. The radiosynthesis is reliable and takes 50 min. Quality control takes another 20 min. All aspects of the protocol, including quality control, are discussed.

用碳 11 ( t _1/2 = 20.4 分钟) 标记的放射性示踪剂广泛用于生物医学研究的正电子发射断层扫描。必须按照规定的时间表生产用于人体正电子发射断层扫描研究的放射性示踪剂，同时还要满足当前的良好生产规范。将实验性放射合成转化为当前良好的生产实践环境具有挑战性。在这里，我们用一个协议来举例说明这种翻译，该协议用于生产用于成像脑转运蛋白 18 kDa 的新兴放射性示踪剂，即 [ ¹¹ C]ER176。这种放射性示踪剂是通过将回旋加速器产生的 [ ¹¹ C] 二氧化碳快速转化为 [ ¹¹ C] 碘甲烷，然后用于处理N -desmethyl-ER176 在碱 ( ^t BuOK) 存在下在室温下放置 5 分钟。[ ¹¹ C]ER176 通过反相 HPLC 分离得到高纯度，并配制为在无菌乙醇盐水中用于静脉注射。放射合成是可靠的，需要 50 分钟。质量控制需要另外 20 分钟。协议的所有方面，包括质量控制，都进行了讨论。