Quality Control of Radiopharmaceuticals^[*]

Summary

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:

1. General aspects including regulations, possibilities, economics and responsibility; and

2. 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.

• References

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