It was recently announced that a new chapter will be published in the USP that will allow users to implement non-animal derived reagents (rFC and rCR) to detect and quantify bacterial endotoxins. USP <86> “Bacterial Endotoxins Test Using Recombinant Reagents” is slated to be official in 2025, and users will be allowed to use traditional LAL or recombinant reagents but it is the users responsibility to verify the method per USP <1226>.
This video covers questions around the impact of the adoption of rCR for product testing, how potential hurdles can be streamlined for labs, the essential validation requirements for implementing recombinant reagents in bacterial endotoxin testing, and more. Access the video below to learn more.
The Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform empowers users to be conscious of today’s needs to protect valuable natural resources while still complying with the strict analytical and regulatory requirements drug and device manufacturers must meet.
This application note demonstrates compatibility of the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform with rCR across various pharmaceutical products, providing a highly efficient, animal-free alternative to Limulus amoebocyte lysate (LAL) endotoxin testing.