Determination of Bacterial Endotoxins in Drugs: False-Negative Results


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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.

Sobre autores

O. Shapovalova

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

Email: chem@folium.ru
Rússia, 8/2 Petrovskii Blvd., Moscow, 127051

N. Neugodova

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

Email: chem@folium.ru
Rússia, 8/2 Petrovskii Blvd., Moscow, 127051

G. Sapozhnikova

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

Email: chem@folium.ru
Rússia, 8/2 Petrovskii Blvd., Moscow, 127051

L. Simutenko

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

Email: chem@folium.ru
Rússia, 8/2 Petrovskii Blvd., Moscow, 127051

A. Agashirinova

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

Email: chem@folium.ru
Rússia, 8/2 Petrovskii Blvd., Moscow, 127051

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