Endotoxins are the natural form of lipopolysaccharide occurring in the outer layer of the bi-layered gram negative bacterial cell wall. The term lipopolysaccharide refers to the pure chemical form.

Health Implications

  • Fever (Pyrogenic reaction) – temperature increase potentially leading to inactivation of enzymic reactions in the human body.
  • Hypoglycemia – drop in glucose levels in blood stream
  • Hypotension – drop in blood pressure

Regulation - Therapeutic Goods Administration (TGA)

TGO No. 50 “General Standard for Pyrogen and Endotoxin Content of Therapeutic Goods; Dated 28 Feb 1995”.

According to TGO No. 50, products from the categories below require analysis:

  • Parenteral products – sterile preparations in the form of injections, intravenous infusions, concentrated solution for injection or medicaments for injection
  • Irrigation solutions
  • Therapeutic devices
  • Goods – where a test for pyrogen or endotoxin content is part of a statutory requirement

Gel Clot Assay Method – Mérieux NutriSciences Method 60

Lysate obtained from circulating amebocytes of the horse-shoe-crab, Limulus polyphemus forms a clot in the presence of endotoxin. Method 60 incorporates the requirements of USP <85>, USP <161> and the guidelines of the TGA and FDA. Limit of detection 0.06 EU/mL (0.03 EU/mL if required).

June 14th, 2019
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