Issues related to reliable quality assessment of oil solutions of medicines with respect to the Bacterial Endotoxins indicator are considered. The maximum isolation of bacterial endotoxins from fat-soluble drugs for subsequent determination is assisted by vigorous stirring of samples in water previously heated to 60°C followed by separation of the two phases using centrifugation at 2300 rpm for 10 min.
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Acknowledgments
The work was performed in the framework of a State Task for SCEEMP, Ministry of Health of Russia, No. 056-00154-19-00 for applied scientific research (State Acct. No. NIR AAAA-A18-118021590049-0).
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 54, No. 5, pp. 58 – 61, May, 2020.
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Shapovalova, O.V., Neugodova, N.P. & Sapozhnikova, G.A. Peculiarities of Determining Bacterial Endotoxins in Oil Solutions of Drugs. Pharm Chem J 54, 539–543 (2020). https://doi.org/10.1007/s11094-020-02234-7
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DOI: https://doi.org/10.1007/s11094-020-02234-7