无载体氯化镥[^(177)Lu]溶液企业内控质量标准的建立

The Establishment of the Enterprise Internal Control Quality Standard for No-carrier-added Lutetium[^(177)Lu]Chloride Solution

为制定放射性治疗药物关键原料无载体氯化镥[^(177)Lu]溶液的企业内控质量标准,建立稳定可靠的分析方法,对氯化镥[^(177)Lu]溶液的放化纯度、放射性核纯度、放射性浓度、元素杂质、内毒素进行检测,并对分析方法进行验证。结果表明,三批次氯化镥[^(177)Lu]溶液各项检测结果均满足要求,放化纯度>99%;放射性核纯度测试中未检测到^(175)Yb以及其他γ射线杂质;各元素杂质含量均符合要求;细菌内毒素含量<2.00 EU/mL;其主要γ能峰能量为0.208 MeV和0.113 MeV;放射性浓度为标示量的90.0%~110.0%。在所建方法、方法验证及三批次检验基础上建立了企业内控质量标准。成功建立了无载体氯化镥[^(177)Lu]溶液的分析方法及企业内控质量标准,可为^(177)Lu治疗药物的制备与转化提供参考。

To establish the stable and reliable analytical methods and the enterprise internal control quality standard for no-carrier-added lutetium[^(177)Lu]chloride solution which is a key material of therapeutic radiopharmaceuticals,the radiochemical purity,radionuclidic purity,radioactivity concentration,element impurities,endotoxin,etc.of lutetium[^(177)Lu]chloride solution were tested,and these analytical methods were verified.Three batches of lutetium[^(177)Lu]chloride solution were tested,and the results met the requirements.The radiochemical purity were greater than 99%,176 Yb and otherγimpurities were not detected in radionuclidic purity test,the contents of impurity elements met the corresponding requirement,bacterial endotoxin was less than 2.00 EU/mL,the mainγenergy peaks of ^(177)Lu were presented at 0.113 MeV and 0.208 MeV,and the radioactivity concentration was 90.0%-110.0%of the concentration declared on the label.The internal control quality standard was established based on the development and verification of the analytical methods and the test results of three batches.The analytical methods and internal control quality standard of no-carrier-added lutetium[^(177)Lu]chloride solution have been successfully established,which laid a foundation for the preparation and translational researches of ^(177)Lu therapeutic radiopharmaceuticals.