Validation of the limulus amebocyte lysate (LAL) test for routine PET radiopharmaceuticals.
The kinetic turbidimetric limulus amebocyte lysate test was validated as method for detecting endotoxins in short-lived radiopharmaceutical samples. Using this method, radiopharmaceuticals can be released for administration to humans after the test, without extensive loss of radioactivity. Inhibition or enhancement on the LAL results by the product samples were examined in more detail and eliminated.
Zijlstra
S
S
Herz- und Diabeteszentrum Nordrhein-Westfalen, Universitätsklinik, Ruhr-Universität, Bochum, Bad Oeynhausen, Germany.
Gerken
P
P
Rechin
C
C
Wortmann
R
R
Notohamiprodjo
G
G
D000641:Ammonia; D004340:Drug Contamination; D004731:Endotoxins / Q000032:analysis*; D005069:Evaluation Studies as Topic; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008033:Limulus Test / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D011868:Radioisotopes / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D014055:Tomography, Emission-Computed
D004731:Endotoxins; D011868:Radioisotopes; D000641:Ammonia