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Endotoxin Testing: New Horizons with Recombinant Reagents

Regulatory Evolution and Introduction of Recombinant Reagents in Endotoxin and Pyrogen Detection

In 2025, we will witness significant regulatory changes in Europe regarding endotoxin and pyrogen detection. With the publication of the new European Pharmacopeia (Ph.Eur.) chapter 5.1.13 on pyrogenicity in January 2025 and modifications to several monographs, the rabbit pyrogen test will be definitively eliminated. Additionally, these updates will facilitate a greater integration of recombinant reagents for endotoxin testing.

At the same time, the United States is also undergoing significant changes. One of the most notable updates is the introduction of USP <86>, which was published in November 2024 and exclusively regulates endotoxin detection.

  

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