【摘要】 建立准确、快捷、方便的放射化学纯度分析方法是放射性创新药物临床转化及开发过程中所面对和攻克的首要问题。本研究对放射化学纯度分析技术的发展现况进行概述，同时，基于现行《中国药典》的相关指导原则，对放射化学纯度分析方法开发及验证所需关注的专属性、准确度和精密度、线性、范围以及耐用性等问题进行探讨。更多还原

【Abstract】 In recent years, the development of innovative radiopharmaceuticals has become a “hot spot”. In these development processes, it is crucial for researchers to createa radiochemical purity analysis method which is accurate, fast, and convenient. In this mini-review, the development trend of radiochemical purity analysis technology is summarized. In addition, based on the guidelines included in the ChP 2020, this mini-review also discusses the key issues in the development and validation of radiochemical purity analysis methods, such as specificity, accuracy and precision, linearity, range, and durability.更多还原