I have calculated MVD for my product and it comes to 70.
Further I prepared dilutions like MVD/32, MVD/16, MVD/8, MVD/4, MVD/2 and MVD.
I got gel clot upto MVD/4 (tested dilution) and no gel clot at MVD/2 and MVD (both tested dilutions)
So my query is:
1. how should I conclude the result for release?
2. What dilution factor should be considered for calculating the exact concentration of endotoxin?
My lysate sensitivity is 0.125EU/ml and EL is 0.25 EU/ml.
we routinely use Charles River instrument and assays. It is the most expensive option (30-40$/test) but its FDA approved, very easy to use, reliable and accurate. Many other kits and test that we tested were suboptimal. That being said, even Charles River assay sometimes needs some optimization for the new samples. You definitely need to find the best dilution, depending on what is present in your sample- plasmid DNA, salts, etc. Mg might be required
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