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.