Quality control of radiopharmaceuticals

A good quality assurance system ensures that a product will be safe and suitable for the intended use. Quality control is an important part of the quality assurance system. Two main topics are discussed in this paper: General aspects including regulations, possibilities, economics and responsibility; and

Methods for the determination of the physical, chemical, pharmaceutical and biological purity with special regard to new methods, problems and pitfalls, e.g. the measurement of radioactivity using an isotope calibrator; the radionuclide purity of 123I; alpha- and beta-emitting impurities in 99mTc ; High performance liquid chromatography (HPLC); Mini-chromatograms; and the value of animal tests.