Bacterial endotoxins are components associated with certain bacteria. Endotoxin testing measures their presence under a defined method, often reported in endotoxin units. It is separate from sterility and general microbial testing.
What the result represents
The reported value may be expressed as EU/mg, EU/mL, EU/vial or as a limit such as less than a stated value. Interpretation requires the unit, dilution and sample basis. A result without its unit is incomplete.
Method suitability matters
Peptides, salts, pH and formulation ingredients can interfere with an endotoxin assay. Laboratories may perform dilution or interference checks to demonstrate that the method can detect endotoxin in the sample matrix.
Do not confuse related tests
Endotoxin testing does not show that a product is sterile, and sterility testing does not replace a defined endotoxin requirement. Bioburden, microbial limits and endotoxin each answer different questions.
- Endotoxin: bacterial endotoxin level
- Bioburden or microbial count: recoverable microorganisms
- Sterility: absence of viable contaminating microorganisms under the specified test
Before submission
Provide the sample form, concentration, available quantity and intended reporting unit. If a specification is required, supply its source or agree it with the responsible laboratory before analysis. QCTests does not treat a research result as approval for human use.