Even in sterile injectables, endotoxins can trigger septic shock, making pre-release lot testing essential. However, stabilizing chelators and surfactants may mask these contaminants in stored samples—a phenomenon known as Low Endotoxin Recovery (LER)—causing false-negative releases.
This poster shows how a dedicated LER dilution buffer counters masking. Samples pre-mixed 9:1 with buffer and read via recombinant Factor C (rFC) assay maintained spiked endotoxin within validity limits after overnight hold in EDTA, Tween 20, and Tween 80. This approach ensures accurate endotoxin measurement, even with highly complex formulations.
Download this poster to see
- Why a β-glucan spike triggers conventional clotting assays while the recombinant signal stays flat
- Which EDTA, Tween 20, and Tween 80 concentrations mask endotoxin spikes
- How biologic sample endotoxin readings change overnight
