Determination of Bacterial Endotoxins in Drugs: False-Negative Results
- Authors: Shapovalova O.V.1, Neugodova N.P.1, Sapozhnikova G.A.1, Simutenko L.V.1, Agashirinova A.A.1
-
Affiliations:
- Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation
- Issue: Vol 51, No 12 (2018)
- Pages: 1119-1122
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244937
- DOI: https://doi.org/10.1007/s11094-018-1751-3
- ID: 244937
Cite item
Abstract
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.
About the authors
O. V. Shapovalova
Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
N. P. Neugodova
Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
G. A. Sapozhnikova
Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
L. V. Simutenko
Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
A. A. Agashirinova
Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051