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Analytical Quality Control

  • Gertrude Pfeiffer
Part of the Developments in Nuclear Medicine book series (DNUM, volume 4)

Abstract

Quality control is the sum of all arrangements made to ensure that a product will be safe and suitable for the intended use. But as Kristensen pointed out (1) “Quality is not an absolute term. When setting up recommendations for preparation and quality control, consideration must be given to economy and time available”. First of all governmental regulations have to be met, but there is a lack of official directions concerning radiopharmaceuticals in many countries and the pharmacopoeias are often not up to date. So decisions concerning the degree of quality control required and the setting of limits for impurities, especially in the case of new radiopharmaceuticals must be made by the manufacturers. They are always looking for fast, precise and simple methods for quality control, so that the given specifications can be tested before the product reaches the patient. Another question is responsibility. It is obvious that the responsibility of the manufacturer ends with the delivery of his products to the hospital. All further manipulations, including dispensing of radiopharmaceuticals and the preparation of Technetium-99m compounds from generator and kits is the responsibility of the hospital pharmacy or the nuclear medicine department, wherever this work will be done.

Keywords

Radiochemical Purity Radionuclidic Purity Radiopharmaceutical Production High Performance Liquid Chromotography Aluminium Aluminium 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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© Martinus Nijhoff Publishers, Boston 1984

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  • Gertrude Pfeiffer

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