Hi all,
Currently, I working on a project to change the endotoxin test for purified water from gel clot to kinetic chromogenic.
Previously, the PW sample tested by gel clot at 10X.
I proposed to test the PW at neat by kinetic chromogenic.
I know the dilution is related to inhibition and enhancement but why the PW is tested at 10X from the start?
I cannot figure out the reason that why PW is tested at 10X, normally water shouldn't have inhibition and enhancement on endotoxin test right? (pH of water is 6-7)
Dear Catherine Wong,
The Maximum Valid Dilution (MVD) should be calculated using the following equation:
MVD = Endotoxin Limit x Product Potency/Lamda
For kinetic testing, Lamda is the lowest point on the standard curve.
This is according to the USP Bacterial Endotoxins Test and USFDA Guidelines for LAL testing.
The water should NOT contain any endotoxin, however, the test is carried out to make sure that the water indeed does comply with the USP and FDA requirements.
For more details on this topic, please see attached file.
Hoping this will be helpful,
Rafik
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