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Whitepaper: Recombinant factor C: new Ph. Eur. Chapter 2.6.32

Posted: 14 December 2020 | | No comments yet

Pharmaceutical and medical device manufacturers can now use the compendial chapter 2.6.32.

Test for bacterial endotoxins using recombinant factor C for their bacterial endotoxin testing (BET) without needing to validate the method. On 1 January 2021, the new general chapter 2.6.32. and
revised general chapter 5.1.10. Guidelines for using the test for bacterial endotoxins, will come into effect.

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