Quality control and GMP synthesis of (68)Ga-prostate-specific membrane antigen-11 for detection of low- and high-grade prostate cancer

Prostate-specific membrane antigen (PSMA) labeled with (68)Ga routinely used with higher sensibility and specificity than other radiotracers for detection of low and high grades of prostate cancer using positron emission tomography (PET)-computed tomography. (68)Ge/(68)Ga generators are generally used with automated modules for the syntheses of (68)Ga radiopharmaceuticals. The aim of the current study is to describe the procedures for labeling PSMA with radiotracers and their standard QC tests. The automated synthesis method for (68)Ga-PSMA-11 was taken and set of a quality control based on chromatographic and spectrometric methods used to determine radiochemical and radionuclide purity of the radiolabeled compound. Meanwhile, high-performance liquid chromatography and rainbow trail Lutheran camp are the best choices after stability tests for assessment of radiochemical purity at the optimized conditions. The clinical utility of the synthesized radiopharmaceuticals was ascertained by performing PET scans in human patients.