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Continue readingUSP<86> use of reagents of non-animal origin in endotoxin assays
The field of Bacterial Endotoxin Testing (BET) is undergoing a significant transformation with the introduction of recombinant technologies.
The USP Expert Committee on Microbiology approved the inclusion of the Chapter Bacterial Endotoxin Testing with Recombinant Reagents, which allows the use of non-animal derived reagents for bacterial endotoxin testing.
This new guideline, which will become official in 2025, will allow the application of reagents of non-animal origin, such as recombinant factor C (rFC) and recombinant cascade reagent (rCR), in the detection and quantification of bacterial endotoxins.
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