Determination of Bacterial Endotoxins in Drugs: False-Negative Results

O. V. Shapovalova; N. P. Neugodova; G. A. Sapozhnikova; L. V. Simutenko; A. A. Agashirinova

doi:10.1007/s11094-018-1751-3

Determination of Bacterial Endotoxins in Drugs: False-Negative Results

作者: Shapovalova O.V.¹, Neugodova N.P.¹, Sapozhnikova G.A.¹, Simutenko L.V.¹, Agashirinova A.A.¹
隶属关系:
1. Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation
期: 卷 51, 编号 12 (2018)
页面: 1119-1122
栏目: Article
URL: https://bakhtiniada.ru/0091-150X/article/view/244937
DOI: https://doi.org/10.1007/s11094-018-1751-3
ID: 244937

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详细

One of the possible causes of false-negatives in bacterial endotoxin determinations, endotoxin aggregation and adsorption, was examined in a model experiment (positive control). A solution for eliminating the interfering actor using kinetic methods and a dispersing solvent was proposed based with the drug caspofungin as an example.

关键词

bacterial endotoxins, interfering factors, inhibition, false-negative results, metal-containing polyanionic dispersing solvent

作者简介

O. Shapovalova

Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation