Rabbit (Oryctolagus cuniculus L.) as the test organism for qualitative bacterial endotoxin detection: presentation of the pyrogen test on rabbits
1997
Arambasic, M.B. (ICN Jugoslavija - Galenika, Beograd (Yugoslavia). Sektor kontrole kvaliteta, Sluzba za biolosku kontrolu)
The paper presents the method of bacterial endotoxin detection in pharmaceutical products (raw materials, finished products and immediate containers) and in water used as solvent in the manufacture of parenteral products: the qualitative pyrogen test in vivo on rabbits (rabbits pyrogen test). The rabbit pyrogen test is a classical test for bacterial endotoxin detection, which is based on the fact that bacterial endotoxins induce a rise in body temperature of a rabbit above the specified limit of body temperature variation. The rabbit (Oryctolagus cuniculus L.) is used as the test organism for pyrogens detection because of the sensitivity of its center for thermoregulation which reacts even on minimum bacterial endotoxin level. The presence of bacterial endotoxins induces high body temperature in rabbits during the first hours after their intake in the body. The reaction is qualitative, of "all or nothing" type.
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