Since first becoming commercially available in 2018, the PET radiopharmaceutical [18F]PSMA-1007 has been used widely for the diagnosis and staging of prostate cancer. A pharmacopoeia monograph first became available in 2021, prescribing a radiochemical purity specification of >91%, based on analytical results from both TLC (for [18F]fluoride impurity alone) and HPLC (for all other 18F-impurities). Though this monograph has provided clarity for the quality control testing of [18F]PSMA-1007, it prescribes a HPLC method using phosphate buffer mobile phase that may present a risk of precipitation of phosphate salts in the HPLC system. The method also requires specialised hardware not immediately available to all laboratories. This work describes the development of a simple, rapid reversed-phase HPLC method utilising 0.1 M ammonium formate mobile phase for the accurate assessment of both [18F]fluoride impurity and overall radiochemical purity in a single test. This method is especially useful for assessment of product stability over time. A more accurate TLC method for [18F]fluoride impurity is also described.
|Number of pages
|Journal of Labelled Compounds and Radiopharmaceuticals
|Published - Mar 2023