浅析放射性药物分析方法的验证  

Brief Analysis of the Validation of Analytical Methods.for

作　　者：陈孟毅 成伟华 李洪玉 CHEN Mengyi;CHENG Weihua;LI Hongyu(HTA Co.,Ltd.,Beijing 102413,China;CAEA Center of Excellence on Nuclear Technology Applications for Engineering and Industrialization of Radiopharmaceuticals,Beijing 102413,China;CNNC Engineering Research Center of Radiopharmaceuticals,Beijing 102413,China)

机构地区：[1]原子高科股份有限公司,北京102413 [2]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]中核集团放射性药物工程技术研究中心,北京102413

出　　处：《同位素》2024年第6期562-567,共6页Journal of Isotopes

摘　　要：分析方法验证是保证分析方法准确可靠的重要步骤,是保证药物质量可控的基础。放射性药物具有放射性、半衰期较短、引入量小等特点,ICH Q2(R1)和中国药典四部通则(9101)等方法验证指导文件并不完全适用于放射性药物分析方法的验证。本研究对放射性核素鉴别、放化纯度、放射性核纯度、放射性活度(浓度)等放射性分析方法验证的内容进行探讨,以期为放射性药物分析方法的验证提供参考。Method validation is an important step to ensure the accuracy and reliability of analytical method,and is the basis for ensuring the controllable quality of drugs.Radiopharmaceuticals have the characteristics of radioactivity,short half-life,and small introduction,etc.The method validation guidance documents such as ICH Q2(R1)and the four general rules of the Chinese Pharmacopoeia(9101)are not fully applicable to the validation of analytical methods for radiopharmaceutical.This paper discusses the validation of radioactivity analytical methods such as radionuclide identification,radiochemical purity,radionuclide purity,radioactivity(concentration),in order to provide a reference for the validation of analytical methods during the development of radiopharmaceuticals.

关 键 词：放射性药物 放射性药物研发 方法验证 放化纯度 

分 类 号：TL99[核科学技术—核技术及应用]