Bacterial endotoxins test · USP <85> · Ph. Eur. 2.6.14
Confirm the labelled lysate sensitivity
Record the gel-clot results of each replicate series at 2λ, λ, 0.5λ and 0.25λ. The tool finds every endpoint, calculates the geometric mean and checks it against the 0.5λ to 2λ acceptance range. The grid opens with an example run of four replicates.
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Labelled sensitivity
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Gel-clot results
Tap a cell to switch between a firm gel (+) and no gel (−).
The pharmacopoeias require at least four replicates.
Result
Geometric mean–EU/mL
Acceptance range–EU/mL
Ratio GM / λ–between 0.5 and 2
geometric meanreplicate endpoints0.5λ to 2λ
About this tool
Before a new lot of gel-clot reagent is used, the laboratory must confirm that its labelled sensitivity λ is reproduced under its own test conditions. This tool turns the replicate results of that confirmation into a clear verdict. It finds the endpoint of each series, calculates the geometric mean endpoint concentration and checks both the acceptance criterion and the validity of the run. It is meant for QC analysts, validation specialists and students.
How it works
Endpoint
In each replicate series, the lowest endotoxin concentration that still forms a firm gel.
Geometric mean = antilog (Σe / f)
e is the log of each endpoint concentration and f is the number of replicates.
Acceptance: 0.5λ ≤ geometric mean ≤ 2λ
The labelled sensitivity is confirmed when the geometric mean falls in this range. The run is valid only if 0.25λ gives a negative result in every replicate.
Educational tool, not validated for GxP use. Results do not replace your laboratory's approved procedures or checking against the current pharmacopoeial chapters.