Pfeiffer G
Nuklearmedizin. 1984 Feb;23(1):4-8.
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.
一个优质的质量保证体系可确保产品安全且适用于预期用途。质量控制是质量保证体系的重要组成部分。本文讨论两个主要主题：一般方面，包括法规、可能性、经济性和责任；以及
测定物理、化学、药学和生物学纯度的方法，特别关注新方法、问题和陷阱，例如使用同位素校准器测量放射性；123I的放射性核素纯度；99mTc中发射α和β射线的杂质；高效液相色谱法（HPLC）；微型色谱图；以及动物试验的价值。
