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

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Sterility

Seen on limitation statements.

Definition

The absence of viable organisms, established only by a specific compendial sterility test under defined conditions. It is not offered as part of any panel on this site.

Neither a low endotoxin result nor a low microbial count establishes sterility. They are different questions answered by different tests.

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.
TAMC and TYMC
Total aerobic microbial count and total yeast and mould count: two separate enumerations run on different media at different temperatures, reported separately.

About contaminant testing

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

Endotoxin unitPositive product controlMaximum valid dilutionColony-forming unitElemental impurityMethod blank

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