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Endotoxin Testing

Endotoxin Testing

Mérieux NutriSciences provides endotoxin testing to ensure that pharmaceutical products are safe for human use.

Endotoxin is a toxic, heat-stable lipopolysaccharide substance present in the outer membrane of gram-negative bacteria that is released from the cell when it lysis

Health Implications

  • Fever (Pyrogenic reaction) – temperature increase potentially leading to inactivation of enzymic reactions in the human body.

Regulation – Therapeutic Goods Administration (TGA)

Microbiological quality of prescription and over the counter medicines, TGO 100, specifies the minimum microbiological requirements that medicine should comply with throughout its shelflife.  Where applicable, a sterile medicine should comply with the harmonised requirements of the Bacterial Endotoxin Test in the current edition of a default standard, as specified in Clause 9 of TGO 100.

Products from the categories below require endotoxin 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 M60, 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).

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