Single radio UHPLC analysis for the quality control of technetium-99m radiolabelled radiopharmaceuticals

Appl Radiat Isot. 2021 Oct:176:109874. doi: 10.1016/j.apradiso.2021.109874. Epub 2021 Jul 21.

Abstract

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.

Keywords: Liquid chromatography; Quality control; Radiopharmacy; Technetium-99m.

MeSH terms

  • Chromatography, High Pressure Liquid / methods*
  • Chromatography, Thin Layer / methods
  • Quality Control*
  • Radiopharmaceuticals / chemistry*
  • Technetium / chemistry*

Substances

  • Radiopharmaceuticals
  • Technetium