[en] The quality control was carried through at seven different generators sold on the market of the Federal Republic of Germany, which were all loaded with fission molybdenum. The Mo-99 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. Application, quality of accessories and their practicability was tested at all generators. The methods of analysis chosen were, among others, gamma spectrometry and thinlayer chromatography; the measuring methods were a site-sensitive proportional counter (measurement of the distribution of radioactivity on the chromatograms) and the atomic absorption spectrometry. The quality control of the Tc-99 m 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 column with Mo-99 at the period of reference was not found. The elution yields with values of 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 μg/ml. The generators had good performance and proved generally to be a reliable source for the generation of Tc-99 m pertechnetate. The application was safe and, with some exceptions, fulfilled the requirements. (orig./HP)

[en] Other than determining the radiochemical purity of several radiopharmaceuticals, a comparison of the different measuring methods of distributing activity on radiochromatograms or electropherograms is intended by this study. For this, the activity distribution in the developed radiochromatograms was assessed by four different measuring methods (TLC-linear analyzer, DC-scanner with NaI(Tl) detector, DC-scanner with gas flow counter and gamma-sample-counter. As shown by the analysis, only the TLC-linear analyzer and the gamma-sample-counter (measurement of chromatograms or electropherograms cut into strips) are generally suitable methods for determining the radiochemical purity of radiochemicals, the DC-scanner with gas flow counter is usable in most cases, while DC-scanner with NaI(Tl) detector is yielding unsatisfactory results. (orig./PW)

[en] 14 different types of pharmaceutical tablets, 18 different pharmaceutical powders, and 32 other solid substances (foodstuffs, environmental materials, etc.) were tested. The results from pharmaceutical powders have shown after optimizing the test conditions that, in some pharmaceuticals, radiation doses of less than 1 Gy were still detectable. Other pharmaceuticals either demonstrated only a slight increase in intensity or none at all. For pharmaceuticals in tablet form, the sample must be processed prior to measurement (deteriorating the detection limit). For examining the various solid substances, materials were selected which are non-soluble or only poorly soluble in luminol solution. All samples were exposed to a radiation dose of 100 Gy. When extrapolating on the basis of a linear dose-effect relation-ship into a lower dose range, it becomes clear that it will be very difficult, if it is possible at all, to find any poorly soluble materials in the liminol solution which could indicate an exposure in the area of 10 Gy or below. (orig./HP)

[en] 14 different types of pharmaceutical tablets, 18 different pharmaceutical powders, and 32 other solid substances (foodstuffs, environmental materials, etc.) were tested as to their suitability for a rapid dose assessment by chemiluminescence measurement. The results from the examined pharmaceutical powders have shown after optimizing the test conditions that, in some pharmaceuticals, radiation doses of less than 1 Gy were still detectable. For pharmaceuticals in tablet form, the sample must be processed prior to chemilumescence measurement. This mechanical process strongly increases the chemiluminescence intensity also of non-irradiated samples and is thus responsible for deteriorating the detection limit. For examining the various solid substances, materials were selected which are non-soluble or only poorly soluble in luminol solution. All samples were exposed to a radiation dose of 100 Gy. When extrapolating on the basis of a linear dose-effect relationship into a lower dose range, it will be very difficult, to find any poorly soluble materials in the luminol solution which could indicate an exposure in the area of 10 Gy or below. This is mainly due to the fact that with insoluble samples the only reaction taking place is the one between the luminol solution and the radiolysis products on the surface. (orig./HP)

[en] Some marketable I-131/I-125/I-123 o-iodohippuric acids were analysed from March to June 1984 with regard to their radiochemical purity and stability. As method of analysis thin layer chromatography was chosen and as method of measurement a TLC linear analyzer was used. At the same time the in vitro stability of the listed radiopharmaceuticals was taken into consideration. It turned out that the I-131 products are subject to a great decomposition. A comparison drawn from several HPLC-measuring methods showed that the selected method of thin-layer chromatography lead to a far better separation of the radiochemical impurities. (orig./PW)

[en] This manual for use in the nuclear medical laboratory is dealing with the quality control of in vivo radiopharmaceuticals while considering the theoretical background of various influencial parameters. Practical and theoretical guidelines are given for quality control tests, as well as possible technical error sources that may result in chromatography related artefacts. The emphasis of this manual lies in a compilation of methods used to analyse the radiochemical impurity of in vivo radiopharmaceuticals. The content of the manual is divided into 6 parts. Part 1 refers to general quality control aspects. Part 2 provides an overview of quality control principles and methods. Part 3 contains the most commonly in vivo radiopharmaceuticals used in tabular form, along with their area of use and current producers/distributors in the Federal Republic of Germany (status December 1985). A compilation of essential analytical methods for investigating radiochemical impurities of in vivo radiopharmaceuticals in nuclear medical routine use is contained in part 4 of the manual. Part 5 describes the most important technical error possibilities in radiochemical quality control. The list of references (part 6) contains review studies of quality control as well as original reports of all of the analytical methods listed. (orig./MG)

[en] The report explains the course of experiments and the method applied (including bibliographic data). The specimens selected for examination are fully described (charge numbers and date of calibration). The number of analyses per charge is given, together with information on parallel analyses made on samples of a given charge (number and dates) during the period of stability of the radiopharmaceuticals. (orig./PW)

[en] Seven different Mo-99/Tc-99m generators, based on fission Mo-99, from seven different manufacturers were studied from September 1984 to January 1985 with regard to their performance and to the quality of the eluates. Results for elution efficiencies, radionuclidic purity, Mo-99 breakthrough, radiochemical purity, pH, and aluminium content of the eluates are presented. (orig./PW)

[en] The purpose of the present study is to examine radiochemical impurities in nine MDP and DTPA kits distributed by different producers and labeled with Tc-99m. Five I-123/I-131 MIBG or amphetamine products from three producers were also impurity tested, together with the in vitro stability of these radiopharmaceuticals. Paper and thin-layer chromatography was used for analysis, next to a position sensitive gas flow counter for measuring the radioactivity distribution on the chromatograms. The study of Tc-99m MDP and TPA basically showed two different radioactive impurities: free pertechnetate and hydrolysed technetium. Free pertechnetate was observed in only a few of the samples: the values were less than 1% of total radioactivity in all cases. Radioiodine labeled MIBG had a free iodide impurity of 1-2.5% of total activity, showing traces of also a second impurity. The radiochemical purity study of I-123 amphetamines resulted in free iodide values of about 1.5%. (orig./RB)

[en] 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 μg/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. (orig.)