[Detection of endotoxins in radiopharmaceutical preparations--III. Limulus test assessment using radiopharmaceutical preparations; correlation with the rabbit pyrogen test].
Experiments using 17 radiopharmaceuticals containing known amounts of added endotoxin show that none of them inhibits the pyrogenic reaction of the rabbit. Gelation of the Limulus amoebocyte lysate (LAL) is inhibited by 4 of them: colloidal erbium 169Er citrate, colloidal rhenium 186Re sulfide, colloidal technetium 99mTc (Re) sulfide for liver scintigraphy and the colloidal technetium 99mTc (Re) sulfide for lymphography. This inhibition is cancelled, either by dilution or after neutral pH adjustment. Both controls were performed on 313 batches of various radiopharmaceuticals, 95% of results were identical (93% negative, 2% positive). The remaining 5% correspond to positive LAL tests vs negative rabbit tests on the same batches. No negative LAL test vs positive rabbit test was observed.
D000818:Animals; D004340:Drug Contamination; D004731:Endotoxins / Q000633:toxicity*; D004926:Escherichia coli; D005188:False Negative Reactions; D005334:Fever / Q000139:chemically induced*; D008033:Limulus Test; D011817:Rabbits; D011868:Radioisotopes / Q000009:adverse effects*; D012015:Reference Standards
D004731:Endotoxins; D011868:Radioisotopes
La recherche des endotoxines dans les préparations radiopharmaceutiques--III. Validation du test Limulus sur les préparations radiopharmaceutiques; corrélation avec l'essai des pyrogènes sur le lapin.