Quality control of radiopharmaceuticals

Radiopharmaceuticals should undergo stringent quality control procedures before being administered to patients. The procedures are broadly categorized as physicochemical and biological tests that ensure purity and safety of the radionuclide as well as the pharmaceutical part. The tests include visual inspection of the final product, radionuclide purity, radiochemical purity, sterility, apyrogenecity and toxicity. While few tests are carried out by the manufacturer for kit based radiopharmaceuticals, most of them need to be conducted on-site on the final product after labelling (author)