Low Endotoxin Recovery and Mitigation Strategies

doi:10.19803/j.1672-8629.20240502

Abstract

Abstract: Objective To investigate the mechanism of low endotoxin recovery (LER) in the process of manufacturing pharmaceuticals, reduce potential endotoxin contamination risks during product release, and prevent pyrogenic products from entering the market that may compromise patient safety. Methods The causes of LER were explored in terms of definitions, mechanisms, differences from other interferences, and mitigation strategies. Results and Conclusion By taking corrective measures for LER, the associated risks can be eliminated, quality control exercised throughout the manufacture, and drug quality supervision and medication safety ensured.

Key words: Low Endotoxin Recovery, Endotoxin Masking, Potential Mechanism, Bacterial Endotoxin Test, Strategies for Mitigation of LER, Quality Control

CLC Number:

R927

PEI Yusheng, XU Lin, ZHAO Yuxin, CAI Tong, HUA Xiaodong. Low Endotoxin Recovery and Mitigation Strategies[J]. Chinese Journal of Pharmacovigilance, 2025, 22(1): 72-75.

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