Bacterial endotoxins test · USP <85> · Ph. Eur. 2.6.14 / 5.1.10

Endotoxin limit and MVD in one step

Calculate the product's K/M endotoxin limit, the maximum valid dilution and the minimum valid concentration. Every formula is shown with your numbers as you type. The preloaded values are an example injectable product.

1

Route of administration (K)

2

Maximum dose (M)

3

Sample and test sensitivity (λ)

λ is the sensitivity of your test: the labelled reagent sensitivity for qualitative methods, or the lowest concentration of the standard curve for quantitative ones.

Result

Endotoxin limit–
MVD–maximum valid dilution
MVC–

Two-fold dilution series

highest valid dilution within MVD beyond MVD, not valid
Useful references: Water for Injection ≤ 0.25 EU/mL. K = 5 EU/kg for parenteral routes, 0.2 EU/kg for intrathecal, 100 EU/m² when the dose is based on body surface area.
Educational tool, not validated for GxP use. Results do not replace your laboratory's approved procedures or checking against the current pharmacopoeial monographs and chapters.