Q:

When performing a Lonza Bacterial Endotoxin Test (BET), LAL or PyroGene™ Recombinant Factor C (rFC), endotoxin detection assay how do I convert from EU/ml (Endotoxin Unit) to ng/ml?

A:
Depending on the source of the endotoxin, the conversion from endotoxin units to nanograms will vary. The FDA initially defined the Endotoxin Unit (EU) as the endotoxin activity of 0.2 ng of Reference Endotoxin Standard, EC-2 or 5 EU/ng. To convert the current FDA RSE, EC-6 from EU into ng, the conversion is 10 EU/ng. Previous versions of the BET chapter <85> in USP stated a suitable CSE has potency between 2 and 50 EU/ng.
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Categories:
Endotoxin Detection
Research Areas:
Endotoxin Testing