Evaluation of the applicability of the bacterial endotoxin test to antibiotic products

被引:16
作者
Yamamoto, A
Ochiai, M
Fujiwara, H
Asakawa, S
Ichinohe, K
Kataoka, M
Toyoizumi, H
Horiuchi, Y
机构
[1] Natl Inst Infect Dis, Dept Safety Res Biol, Tokyo 2080011, Japan
[2] Natl Inst Infect Dis, Dept Bacterial & Blood Prod, Tokyo 2080011, Japan
关键词
endotoxin test; antibiotics; LAL; safety quality control;
D O I
10.1006/biol.2000.0251
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
Fundamental conditions for applying the bacterial endotoxin test to antibiotic products were investigated so as not to affect the level of regulation by the rabbit pyrogen test. According to accuracy evaluation of test methods, the kinetic-turbidimetric and kinetic-colourimetric assays were shown to allow more accurate measurement and, therefore, more sensitive detection of interference to the bacterial endotoxin test than the gel-clot method. In total, 102 antibiotic products were evaluated on their interfering effect to show that the antibiotics could be categorized into three groups depending on intensity of the interference. Although the test was shown to be applicable even to the group showing the strongest interference, it was assumed to be crucial to use appropriate reagents and an accurate test method for avoiding approval of a pyrogenic product. Accordingly, lists of antibiotics are presented to provide limits of concentration for eliminating interference and endotoxin limits for approval to facilitate effective bacterial endotoxin tests. (C) 2000 The International Association for Biologicals.
引用
收藏
页码:155 / 167
页数:13
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