Introducing the rFC method, chapter <86> of the USP
The new chapter <86> of the USP includes the establishment of alternative, non-animal reagents for testing for bacterial endotoxins in order to reduce the use of animals in the pharmaceutical and medical device industry. The recombinant factor C (rFC) and the recombinant cascade reagents are alternative methods to the classic LAL test. In the European Pharmacopoeia, the rFC has long been anchored in chapter 2.6.32.
The rFC method is therefore an internationally recognized alternative to the LAL method and is recognized in the USA.
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