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Answer:

Recommended methods include:

  • Monocyte-activation test (MAT) (general chapter 2.6.30) for broad pyrogen detection;
  • Bacterial endotoxins test (BET) using:
    • limulus amoebocyte lysate (LAL)-based methods (general chapter 6.14);
    • recombinant factor C (rFC) (previously general chapter 6.32, in general chapter 2.6.14. as of Issue 13.1).

According to general chapter 5.1.13. Pyrogenicity, users must apply a risk-based approach if selecting the test for bacterial endotoxins as the sole method to assess pyrogenicity.

Please also consult the EMA’s Quality of medicines questions and answers: Part 1 European Pharmacopeia (Ph. Eur.) - Phasing out Rabbit Pyrogen Test.

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