The radiochemical purity (RCP) determination of radiopharmaceuticals is routinely done with radio-thin layer chromatography (r-TLC). These methods are usually transposed and adjusted from the summary product characteristics without any analytical validation. The r-TLC method is simple but manually-performed steps could lead to RCP misinterpretation. To increase the sensitivity, radio ultra-high performance liquid chromatography (r-UHPLC) can be used. In this study, an r-UHPLC method had been validated and compared to the r-TLC method. Hydrolyzed-reduced technetium had also been studied.

中文翻译：

---

单放射性 UHPLC 分析用于锝 99m 放射性标记放射性药物的质量控制

放射性药物的放射化学纯度 (RCP) 测定通常使用放射性薄层色谱法 (r-TLC) 进行。这些方法通常是在没有任何分析验证的情况下，根据产品特性的概要进行转换和调整的。r-TLC 方法很简单，但手动执行的步骤可能会导致 RCP 误解。为了提高灵敏度，可以使用无线电超高效液相色谱 (r-UHPLC)。在本研究中，对 r-UHPLC 方法进行了验证，并与 r-TLC 方法进行了比较。还研究了水解还原的锝。