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
- 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).