Endotoxin testing, USP <85>, also known as the Bacterial Endotoxins Test (BET) or Limulus Amebocyte Lysate (LAL) test, is an in vitro assay used to detect and quantify bacterial endotoxins in pharmaceutical products like injectables and medical devices. Bacterial endotoxins may be present in a raw material or finished product even when no viable microbial cells remain.
Endotoxins may cause many side effects ranging from minor fever and inflammation to severe symptoms impacting respiratory and cardiovascular systems.
Endotoxins may cause many side effects ranging from minor fever and inflammation to severe symptoms impacting respiratory and cardiovascular systems. These risks are particularly significant in injectable and parenteral products. Endotoxin testing is an essential component of safety testing for some products.
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