Quality control of positron emission tomography radiopharmaceuticals: An institutional experience

PURPOSE OF THE STUDY: To study quality control parameters of routinely prepared positron emission tomography (PET) radiopharmaceuticals. MATERIALS AND METHODS: Three PET radiopharmaceuticals fluorine-18 fluorodeoxyglucose (F-18 FDG), N-13 ammonia (N-13 NH(3)), and Ga-68 DOTATATE (n = 25 each), prepared by standardized protocols were used. The radionuclide purity, radiochemical purity, residual solvents, pH, endotoxins, and sterility of these radiopharmaceuticals were determined. RESULTS: The physical half-life of radionuclide in radiopharmaceuticals, determined by both graphical and formula method, demonstrated purity of radionuclides used. pH of all PET radiopharmaceuticals used was in the range of 5-6.5. No microbial growth was observed in radiopharmaceutical preparations. The residual solvents, chemical impurity, and pyrogens were within the permissible limits. CONCLUSIONS: All three PET radiopharmaceuticals were safe for intravenous administration.