Independent analytical testing. Results apply only to the sample received, for research use only.

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Bacterial endotoxin

Seen on endotoxin reports.

Definition

A lipopolysaccharide component of Gram-negative bacterial cell walls, measured because it is heat-stable and survives processes that kill the organism itself. It is measured here by kinetic chromogenic LAL, with recombinant factor C available on request.

An endotoxin result is not a sterility result. It measures a cell-wall component and does not detect viable organisms of any kind.

Related terms

Endotoxin unit
The unit an endotoxin result is expressed in, written EU, defined against a reference standard endotoxin and normally reported per millilitre or per stated sample basis.
Sterility
The absence of viable organisms, established only by a specific compendial sterility test under defined conditions.

About contaminant testing

Endotoxin and elemental impurities, what neither of them establishes, and the microbiological vocabulary a reader still meets elsewhere.

Positive product controlMaximum valid dilutionTAMC and TYMCColony-forming unitElemental impurityMethod blank

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