Choosing Bacterial Endotoxin Detection Method
Abstract
Various test methods are used to detect and quantify bacterial endotoxins: a gel-clot test, which is arbitral and is based on the formation of a gel, and photometric (instrumental) tests that determine the intensity of the color or turbidity in the test solutions. In this article we consider the features of modern methods for detecting bacterial endotoxins, their advantages and disadvantages. Based on information analysis and practical experience, the main criteria for choosing a method for determining pyrogenic impurities are established. The gel-clot test and photometric determinations of bacterial endotoxins are sufficiently reliable and reproducible. The choice is left for the analyst when all necessary equipment and reagents are available.Instrumental methods are used in rare case due to their high sensitivity, which allows to avoid the influence of interfering factors in the LAL-test.
About the Authors
O. V. Shapovalova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
N. P. Neugodova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
G. A. Sapozhnikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
References
1. ГФ XIII «Бактериальные эндотоксины» ОФС.1.2.4.0006.15 / GF XIII «Bakterial'nye endotoksiny» OFS.1.2.4.0006.15 [in Russian]
2. Неугодова Н.П., Рябцова M.C., Сапожникова Г.А. Основные требования к биологическим показателям при оценке качества лекарственных средств. Возможности валидации биологических методов контроля. Ведомости Научного Центра Экспертизы Средств Медицинского Применения. - 2016. - № 3. - С. 3-7
3. Ситников А. Г., Травина Л.А., Багирова В.Л. ЛАЛ - тест. Современные подходы к определению пирогенности. М.: 1997. - С. 19-26
4. ResearchGate [Электронный ресурс] - Режим доступа: https://www.researchgate.net/publication/299507542_LAL_Choice_of _Test_Method - LAL: Choice of Test Method - (Дата обращения: 28.11.2017)
5. Sandle T. Pyrogens, Endotoxin and the LAL Test: An Introduction in Relation to Pharmaceutical Processing.Global BioPharmaceutical Resources Newsletter. 2012; 1-16
6. Dawson M. E. A Wealth of Options Choosing an LAL Test Method. LALUpdate 1995; 13: 3: 6.
7. Joiner T. J., Kraus P.F, Kupies T.C. Comparison of Endotoxin Testing Methods for Pharmaceutical Products.International Journal of Pharmaceutical Compounding.2002; 6: 6: 408-409.
8. Timothy J. Joiner, Paul F. Kraus, Thomas C. Kupiec, PhD «Comparison of Endotoxin Testing Methods for Pharmaceutical Products», International Journal of Pharmaceutical Compounding, Vol. 6 No. 6 November/December 2002, р.408-409.
9. Barnard Health Care [Электронныйресурс] Режим доступа: https://www.barnardhealth.us/limulus-amebocyte/overview-of-promi-nent-lal-tests.html - Overview Of Prominent LAL Tests - (Дата обращения: 23.02.2017).
10. Berzofsky R. N. Endotoxin detection in pharmaceuticals and medical devices with kinetic-QCL, a kinetic-quantitative chromogenic limulus amebocyte lysate assay. ALTEX 1995; 12 (2): 93-97.
11. Williams K.L. Endotoxins Pyrogens, LAL Testing and Depyrogenation third Edition, 2007.
12. Bacterial endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing, Association for the Advancement of Medical Instrumentation (AAMI), 2002/R2010.
Review
For citations:
Shapovalova O.V., Neugodova N.P., Sapozhnikova G.A. Choosing Bacterial Endotoxin Detection Method. Antibiot Khimioter = Antibiotics and Chemotherapy. 2018;63(5-6):43-45. (In Russ.)
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