Development and validation of a UV-Radio-HPLC method to assess chemical and radiochemical purity of [68Ga] Ga-PSMA-11

[68Ga]Ga-PSMA-11, a urea-based peptidomimetic, has been widely used in recent years for PET imaging of patients with prostate cancer. Since it has short half-life and should be in-house synthesized, synthesis conditions may affect quality and in vivo behavior of [68Ga]Ga-PSMA-11. Therefore in this study we aimed to develop an alternative, simple and validated HPLC method to test chemical and radiochemical purity of [68Ga]Ga-PSMA-11 for clinical routine. • A new, simple and sensitive UV- Radio-HPLC method for chemical and radiochemical purity testing of [68Ga]Ga-PSMA-11. • Easily found stationary and mobile phase combination. • First alternative mobile phase combination used over trifluoroacetic acid. • QC testing for both radiochemical and chemical purity by UV-Radio-HPLC/instant thin-layer chromatography (ITLC) and UV-Radio-HPLC, respectively.