Bacterial Endotoxin Testing

Endotoxin is not alive, and sterility and bacterial-endotoxin status are not interchangeable. Chemical identity and chromatographic purity do not establish either one.

The sample matrix can inhibit or enhance the assay. Suitability testing and appropriate controls are needed to show that the method can detect endotoxin in the specific material under the chosen conditions.

A useful report includes the method, sample preparation, dilution, units, detection or quantitation limit where applicable, controls, recovery, result, and acceptance criterion. A bare word such as pass is not enough.