Quality Control of Radiopharmaceuticals

Abstract

SummaryA 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:1. General aspects including regulations, possibilities, economics and responsibility; and2. Procedures: 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 radionuclidic purity of 123I;– alpha and beta-emitting impurities in 99mTc;– High-performance liquid chromatography (HPLC);– Mini-chromatograms; and– the value of animal tests.