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The Bacterial Endotoxin Test, using LAL methodology, is a key in-process and final product release test for sterile pharmaceuticals and medical devices. One of the challenges with LAL methodology is overcoming interfering substances as demonstrated by inhibition or enhancement of an endotoxin challenge. Here, Bio Products Laboratory’s Dr Tim Sandle discusses the interfering substances issue and provides some guidance to overcome it.
Sandle, T. (2021) Bacterial endotoxin test using LAL methodology: overcoming interfering factors, European Pharmaceutical Review, Issue 4,Special Supplement: QA/QC Environmental Monitoring, at: https://edition.pagesuite.com/html5/reader/production/default.aspx?pubname=&edid=8011f861-3b23-409f-beb7-5bae16d120c4
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)