The LAL test has ensured the absence of pyrogens in raw materials, water for injection systems, in-process samples, and in the final products.” The LAL assay works via the reaction of the LAL ...

Champion calls the monocyte activation test “far preferable” to endotoxin testing. But while regulators in Europe, Japan, and India recognize it, the test is not yet in the pharmacopoeia in ...

Inadequate endotoxin testing places patients at risk. Knowing the relative strengths and weaknesses of available test methods is crucial to maintaining quality and safety. Endotoxins are small, ...

Now it appears that the tide may be turning on endotoxin tests made from horseshoe crab blood—but it hasn’t gone out just yet. And it’s not used to test only products that go into humans.

Health ministry issues draft notification to amend D&C Rules to bring in several changes: Gireesh Babu, New Delhi Saturday, May 31, 2025, 08:00 Hrs [IST] The Union health ministry ...

known as the U.S. Pharmacopeia (USP), to adopt rFC as an alternative test for endotoxins, alongside LAL. If drug companies continue to rely solely on LAL, they say, horseshoe crab populations will ...

This webinar will help the attendee gain an understanding of the requirements of current USP <85> Bacterial Endotoxin Test (BET) European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia ...

Pharmaceutical companies capture and extract blood from the other 700,000 to make the endotoxin test before releasing them to the sea. Up to 30 percent may die as a result. Many others never make ...

WILMINGTON, Mass., January 29, 2024--(BUSINESS WIRE)--Building upon its flagship Endosafe ® cartridge technology, Charles River Laboratories International, Inc. (NYSE: CRL) has advanced this ...

drug companies have depended on a component in the blood of the horseshoe crab to test injectable medicines, including vaccines, for dangerous bacterial contaminants called endotoxins ...