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Low Endotoxin Recovery Case Study

This content was first published by European Pharmaceutical Review (EPR).

   

Introduction

Since CHEN and VINTHER first described a unique drug formulation phenomenon that renders the detection of endotoxin using Limulus-based methods ineffective, the debate has raged as to how the phenomenon should best be mitigated. The phenomenon was labelled “Low Endotoxin Recovery”.

This case study discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference.

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Low-Endotoxin-Recovery-Case-Study.pdf
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