Single Radio Uhplc Analysis For The Quality Control Of Technetium-99m Radiolabelled Radiopharmaceuticals

APPLIED RADIATION AND ISOTOPES(2021)

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摘要
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.
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关键词
Radiopharmacy, Quality control, Technetium-99m, Liquid chromatography
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