使用示踪剂生产系统（TPS）自动进行α-[C]甲基-L-色氨酸的GMP生产。
Automated GMP-production of α-[ C]methyl-L-tryptophan using a tracer production system (TPS).
作者信息
Nordeman Patrik, Yngve Ulrika, Wilking Helena, Gustavsson Sven Åke, Eriksson Jonas, Antoni Gunnar
机构信息
Department of Medicinal Chemistry, Uppsala University, Uppsala, Sweden.
Science for Life Laboratory, Drug Discovery and Development Platform, Department of Medicinal Chemistry, Uppsala University, Uppsala, Sweden.
出版信息
J Labelled Comp Radiopharm. 2018 Dec;61(14):1106-1109. doi: 10.1002/jlcr.3648. Epub 2018 Jun 26.
The radiosynthesis and GMP validation of [ C]AMT for human use are described. Three consecutive batches were produced giving 940-3790 MBq (4%-17% RCY, decay corrected, based on [ C]CO ) of the tracer. The molar activity at the end of synthesis was 19 to 35 GBq/μmol, the radiochemical purity was ≥98%, and the enantiomeric purity was >99%. While the synthesis method was automated using a new generation of synthesis equipment, tracer production system developed in house, the method should be readily applicable to other synthesis platforms with minor modifications.
描述了用于人体的[C]AMT的放射性合成及药品生产质量管理规范（GMP）验证。连续生产了三批示踪剂，产量为940 - 3790兆贝克勒尔（基于[C]CO，经衰变校正后的回收产率为4% - 17%）。合成结束时的摩尔活度为19至35吉贝克勒尔/微摩尔，放射化学纯度≥98%，对映体纯度>99%。虽然合成方法是使用新一代合成设备（内部开发的示踪剂生产系统）实现自动化的，但该方法稍作修改后应易于应用于其他合成平台。
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