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

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Positive product control

Seen on endotoxin reports.

Definition

A spiked sample run alongside the test to demonstrate that the sample itself is not inhibiting or enhancing the reaction. Its recovery is reported, because without it a clean endotoxin result cannot be distinguished from an inhibited one.

Related terms

Bacterial endotoxin
A lipopolysaccharide component of Gram-negative bacterial cell walls, measured because it is heat-stable and survives processes that kill the organism itself.

About contaminant testing

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

Endotoxin unitMaximum valid dilutionTAMC and TYMCColony-forming unitSterilityElemental impurityMethod blank

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