Determination of Bacterial Endotoxins in Drugs: False-Negative Results


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Аннотация

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.

Авторлар туралы

O. Shapovalova

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

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

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