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Pharmaceuticals

Animal-free endotoxin testing approved

by Laurel Oldach
August 5, 2024 | A version of this story appeared in Volume 102, Issue 24
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Most Popular in Pharmaceuticals

 

A blue-green horseshoe crab.
Credit: Shutterstock
Horseshoe crabs are the source of a key ingredient in endotoxin testing.

The US Pharmacopeia has approved new testing guidelines for sterile pharmaceutical products. Injected and implanted products must be free from bacterial endotoxins, which can cause inflammation. Widely used current tests rely on reagents extracted from wild horseshoe crabs, a practice that environmentalists say strains ecosystems. Synthetic alternatives have been approved in several countries, but US drug makers have been reluctant to change testing processes without a regulatory green light. The new guidelines will take effect in May 2025.

CORRECTION

This story was updated on Sept. 24, 2024, to correct an error in the caption. Horseshoe crabs are the source of a key ingredient in endotoxin tests, not sterility tests.

Chemical & Engineering News
ISSN 0009-2347
Copyright © 2024 American Chemical Society

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