Endotoxin Test
The Bacterial Endotoxins Test (BET) is a test to detect or quantify endotoxins from Gram-negative bacteria. The endotoxin testing, also known as LAL (Limulus Amebocyte Lysate) testing, is an essential part of pharmaceutical microbiology testing. Endotoxins are pyrogen and fever-inducing substances that can be harmful or even fatal if administered to humans above certain concentrations.
In addition to pharmaceutical products and medical devices, water can also contain endotoxins. Therefore, it is crucial to perform endotoxin testing to monitor water systems routinely.
How SIG can help
SIG laboratory provides endotoxin testing for pharmaceutical products and medical devices, including hemodialysis water and WFI (water for injection).
Method of Analysis
SIG Laboratories uses the Gel Clot testing method with the reference method USP 42-NF 37 :2019 <85> and <161>.
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