1. Quality control of radiopharmaceuticals.
- Author
-
Pfeiffer G
- Subjects
- Drug Labeling standards, Drug Packaging standards, Germany, West, Iodine Radioisotopes standards, Radioactive Tracers standards, Technetium standards, Legislation, Drug, Quality Control, Radioisotopes standards
- Abstract
Unlabelled: 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, 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 radionuclide purity of 123I; alpha- and beta-emitting impurities in 99mTc ; High performance liquid chromatography (HPLC); Mini-chromatograms; and the value of animal tests.
- Published
- 1984