Quality control of radiopharmaceuticals
In hospitals, most radiopharmaceuticals are prepared by reconstituting ready-to-use kits with appropriate radionuclide. This reconstitution procedure results in the formation of a ‘new’ chemical compound. Therefore quality control tests must be performed after the final step of the preparation of the radiopharmaceutical in addition to those required for nonradioactive drugs. The quality control tests associated with the ‘kits’ formulation and production of radionuclides from primary sources are performed by manufacturers, while those associated with the final step of the preparation of the radiopharmaceutical are performed in the radiopharmacy. Broadly, two classes of quality control tests are performed: biologic and physicochemical.
KeywordsRadiochemical Purity United States Pharmacopeia Solvent Front Quality Control Test Radionuclidic Impurity
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