Fission 99Mo/99mTc Generators--a study of their quality.

Quality was controlled of seven different 99Mo/99mTc generators sold in the Federal Republic of Germany, which were all loaded with fission molybdenum. Aim of the work was to test the 99mTc eluates for their radionuclidic and radiochemical purity. Furthermore, the 99Mo content of the aluminium oxide column was measured. Determination of the elution efficiency, measurement of the pH-value of the eluate as well as a test to detect soluble aluminium in the eluate were also performed. In addition to the chemical and physical examinations, application, quality of accessories and their practicability were tested at all generators. The methods of analysis chosen were, among others, gamma spectrometry and thin-layer chromatography; the measuring methods were a site-sensitive proportional counter (measurement of the distribution of radioactivity of the chromatograms) and atomic absorption spectrometry (Al content of the eluates). The quality control of the 99mTc eluates had satisfying results. The eluates showed - with one exception - high and sufficient radionuclidic purity and very good radiochemical purity. A considerable overload of the columns with 99Mo at the time of reference was not found. The elution yields with values between 85 and 122% were in good agreement with the requirements. All eluates had pH-values between 5.0 and 6.5, and an aluminium content below 1 microgram/ml. The generators had good performance and proved generally to be a reliable source of 99mTc-pertechnetate. The application was safe and, with some exceptions, fulfilled the requirements.