同位素2026，Vol.39Issue(2)：140-147,8.DOI:10.7538/tws.2026.youxian.009
[68Ga]Ga-DOTA-CXCR4-D1放化纯度测定方法的建立与验证
Development and Validation of a Radiochemical Purity Determination Method for[68Ga]Ga-DOTA-CXCR4-D1
于菁菁 1王晓明 2李厚全 2周旭 2李洪玉 2裴杨 2秦祥宇 2温凯 2王国宝3
作者信息
- 1. 中国原子能科学研究院,北京 102413||原子高科股份有限公司,北京 102413||中国核工业集团有限公司 放射性药物工程技术研究中心,北京 102413||国家原子能机构核技术(放射性药物工程转化)研发中心,北京 102413
- 2. 原子高科股份有限公司,北京 102413||中国核工业集团有限公司 放射性药物工程技术研究中心,北京 102413||国家原子能机构核技术(放射性药物工程转化)研发中心,北京 102413
- 3. 中国原子能科学研究院,北京 102413
- 折叠
摘要
Abstract
CXCR4 is a chemokine receptor widely overexpressed on the surface of various tumor cells.Given its pivotal role in tumor invasion,metastasis,and recurrence,it has emerged as a key target in molecular imaging.Radiochemical purity is one of the critical quality attributes(CQAs)of diagnostic agents.For the novel 68Ga-labeled CXCR4-targeted diagnostic agent with a cyclic octapeptide scaffold designed in this study,an analytical method based on high-performance liquid chromatography coupled with a radioactive detector(Radio-HPLC)was established for the determination of its radiochemical purity.Validation experiments focusing on specificity,linearity,repeatability,and quantification limit(QL)confirmed that the method could accurately detect the main radioactive component and impurities of the agent.The validation results showed that the resolution between the main component and impurities all exceeded 1.5,demonstrating the method's capability to identify potential radiochemical impurities;the correlation coefficient was greater than 0.99 over the injected radioactivity range of 0.011 to 1.11 MBq;the relative standard deviation(RSD)of the radiochemical purity repeatability test was 0.4%;and the QL was 0.011 MBq,enabling the quantitative determination of 1%radiochemical impurities.This analytical method is rapid,specific,and good consistency,and can serve as a reliable quality control tool for subsequent drug quality research and process development.关键词
CXCR4/68Ga/放化纯度/质量控制/放射性高效液相色谱法Key words
CXCR4/68Ga/radiochemical purity/quality control/radio-HPLC分类
医药卫生引用本文复制引用
于菁菁,王晓明,李厚全,周旭,李洪玉,裴杨,秦祥宇,温凯,王国宝..[68Ga]Ga-DOTA-CXCR4-D1放化纯度测定方法的建立与验证[J].同位素,2026,39(2):140-147,8.
