title: [LAL test used for detection of undesirable biologically active substances in biopreparations].
abstract: Detection of bacterial endotoxin was performed in four groups of biopreparations: IVIG, virus and bacterial vaccines and antibiotics. The 44 samples of biopreparations were tested by the qualitative LAL-test (gel-clot) and some of them (22 samples) by the quantitative, LAL-test (chromogenic end-point). The concentration of endotoxin in 10 samples of IVIG was in the range from 0.457 EU/ml to 19.46 EU/ml. Only 4 of them did not exceed the limit recommended by FDA for human globulins (5 EU/ml). In the 9 samples out of 10 samples of virus vaccines the presence of endotoxin was in the range from 0.06 to 0.15 EU/ml. The concentration of endotoxin in 10 samples of bacterial vaccines determined by gel- clot method was below sensitivity of test (2 EU/ml). In antibiotics we did not find the presence of endotoxin in the range recommended by Ph. Eur. 1995 limits (0.1-0.2 EU/ml). The presented data show the necessity for requirements elaboration for each type of biopreparations.
authors.affiliation: Zakład Badania Surowic i Szczepionek, PZH w Warszawie.
authors.forename: J
authors.initials: J
authors.lastname: Aleksandrowicz
authors.forename: M
authors.initials: M
authors.lastname: Fiejka
authors.forename: Z
authors.initials: Z
authors.lastname: Kudelski
authors.forename: A
authors.initials: A
authors.lastname: Marciniak-Rusek
authors.forename: L
authors.initials: L
authors.lastname: Paśś-Dziegielewska
mesh_terms: D000900:Anti-Bacterial Agents / Q000032:analysis*; D004340:Drug Contamination / Q000517:prevention & control*; D004731:Endotoxins / Q000032:analysis*; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000032:analysis* / Q000592:standards; D008033:Limulus Test; D014481:United States; D014486:United States Food and Drug Administration; D014612:Vaccines / Q000032:analysis*
chemical_list: D000900:Anti-Bacterial Agents; D004731:Endotoxins; D016756:Immunoglobulins, Intravenous; D014612:Vaccines