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The topic of pyrogen and endotoxin tests, i.e. tests for contamination of parenteral substances, is complex and has a decades-long tradition. In the following, we want to provide more information and make the topic understandable for everyone.
Pyrogen and endotoxin tests are critical procedures in pharmaceutical and biomedical industries to ensure the safety of drugs, medical devices, and biological products. Pyrogens are substances that can induce fever if introduced into the body, while endotoxins are a specific type of pyrogen found in the outer membrane of Gram-negative bacteria.
These tests detect the presence of these harmful contaminants to prevent adverse reactions in patients. Commonly used methods include the Rabbit Pyrogen Test (RPT), the Limulus Amebocyte Lysate (LAL) test, and modern alternatives like the Monocyte Activation Test (MAT). Each method aims to ensure that pharmaceutical products meet stringent safety standards before being released to the market.