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 NH3), 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.