同位素2024，Vol.37Issue(6)：562-567,6.DOI:10.7538/tws.2023.youxian.104
浅析放射性药物分析方法的验证
Brief Analysis of the Validation of Analytical Methods for Radiopharmaceuticals
陈孟毅 1成伟华 1李洪玉1
作者信息
- 1. 原子高科股份有限公司,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||中核集团放射性药物工程技术研究中心,北京 102413
- 折叠
摘要
Abstract
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Key words
radiopharmaceutical/radiopharmaceutical research and development/method validation/radiochemical purity分类
能源科技引用本文复制引用
陈孟毅,成伟华,李洪玉..浅析放射性药物分析方法的验证[J].同位素,2024,37(6):562-567,6.
