[Quality control of radiopharmaceuticals from the clinical aspect--a necessity?].
Radiopharmaceuticals are a special group of drugs since many are eventually prepared in the hospital and the nuclear medicine department is responsible for meeting quality criteria such as sterility, radionuclide, radiochemical and chemical purity of these drugs. We tested 266 preparations of 14 different radiopharmaceuticals from commercial kits for their radiochemical purity. Only four compounds showed deficiencies in labelling (anti-granulocyte MAb, HIG, HMPAO, MAG3, altogether 18 preparations). All of them were 99mTc-pharmaceuticals with a relatively low tin content of the kit. The reasons for the poor quality of these products could be found. This study shows the importance of a good quality control system (including other tests like sterility and environmental monitoring) to guarantee the safety and efficacy of radiopharmaceuticals prepared in the hospital.
Decristoforo
C
C
Universitätsklinik für Nuklearmedizin, Innsbruck, Austria.
Chen
F
F
Riccabona
G
G
D006801:Humans; D009684:Nuclear Medicine Department, Hospital / Q000592:standards*; D011785:Quality Assurance, Health Care; D011933:Reagent Kits, Diagnostic / Q000592:standards
D011933:Reagent Kits, Diagnostic
Qualitätskontrolle von Radiopharmaka in der Klinik--eine Notwendigkeit?