Whitepaper: Analytical criteria in bacterial endotoxin testing using LAL and rFC
Posted: 21 February 2019 | Hyglos-bioMerieux | No comments yet
This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate analysis; hence, their understanding can ultimately facilitate robust BET and in turn keep patients safe from endotoxin.
A part from gel clot LAL tests, BET is purely quantitative; ie, the endotoxin activity is returned as defined, indiscreet endotoxin units (EU; also known as international units, IU). Since liquids are analysed, activities are commonly converted into concentrations – eg, EU/mL – and in turn to other units of measurement, eg, EU/mg. The different BET methods are subject to a) compendial criteria and b) test-dependent criteria as developed by reagent manufacturers; criteria meant to guarantee robust test performance.
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