Low Endotoxin Recovery

Low Endotoxin Recovery (LER) is the product-specific inhibition of the bacterial endotoxin test not due to assay interference. The prevailing thought is that endotoxin detection is dependent on supramolecular structure and excipients in pharmaceutical products can destablilize endotoxin complexes, leading to samples containing endotoxin monomers that are not detected by standard assays. Such “false negatives” could lead to significant pyrogenic reactions if aggregation were to take place in vivo. Sample treatments (such as divalent cations, dispersants and proteases) to induce the aggregated state have been shown to have promise, though, results appear to be sample-specific.

Facing Up to the Challenge of Low Endotoxin Recovery

low endotoxin recovery

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