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).

August 1st, 2019
Company News , Local News
As part of our continued commitment to enhance our property and service, we will be undergoing renovations of our Perth laboratory during the month of August and will be scheduled for completion a...
July 11th, 2019
Acquisitions , Company News , Market News
We have recently acquired the Italian company EcamRicert and expanded our capabilities in environmental analyses and nanotechnologies.