Bacterial Endotoxin Testing Factsheet

Bacterial Endotoxin Testing (BET) is critical for detecting pyrogens in pharmaceutical and medical device products. Endotoxins from gram-negative bacteria can trigger severe inflammatory responses, making BET a regulatory requirement for products such as injectables and dialysis solutions.

Cormica provides a complete range of BET services using validated compendial methods and operates accredited labs across the UK, US, and EU. BET is part of our broader pyrogen testing offering, which also includes the Monocyte Activation Test (MAT) for detecting non-endotoxin pyrogens.

What’s Inside the Factsheet?

This downloadable factsheet includes:

  • A scientific overview of bacterial endotoxins and their clinical relevance
  • Historical context and evolution of pyrogen testing methods
  • Details on Cormica’s validated BET methodologies (Gel Clot, Chromogenic, and Turbidimetric)
  • Applicable pharmacopeial standards (Ph. Eur., USP, JP)
  • Considerations for test accuracy, limitations, and complementary testing
  • An outline of Cormica’s comprehensive testing approach and regulatory alignment

Download Now and Take the Next Step

Gain the knowledge you need to strengthen your endotoxin control strategy with confidence. Download the BET factsheet today and discover how you can ensure regulatory compliance, protect patient safety, and accelerate product release.

Cormica are dedicated to supporting the safe and efficient development of pharmaceuticals and medical devices. Contact us to learn how our endotoxin and pyrogen testing services, including BET and MAT, can support your regulatory and quality objectives.

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Published:

13/05/2025

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