Reduction of reference standard endotoxin activity was kinetically analyzed under low
endotoxin recovery conditions and was considered as an apparent first-order reaction …

Dilution of samples with water (water dilution method) was not appropriate for measuring the
endotoxin activity in solutions containing chelating agents and detergents—typical …

Endotoxins are cell wall components of Gram-negative bacteria. A release of endotoxins into
the human blood stream results in an inflammation reaction that can lead to life-threatening …

The inability to detect endotoxin added to undiluted drug samples has been called: Low
Endotoxin Recovery (LER). The phenomenon has caused concerns amongst drug …

The initial studies of the “LER” phenomenon describe a sudden and irreversible loss of
“endotoxin activity” when Control Standard Endotoxin (CSE), in the form of chemically …

Endotoxins are a highly pyrogenic and immunogenic contaminant of bacterial origin that
must be avoided during the manufacturing of biopharmaceutical products to ensure safety …

Endotoxin must be controlled in the manufacturing of parenteral drug products to prevent
adverse reactions in patients. Endotoxin contamination may arise in the manufacturing of …

ABSTRACT Mechanism of Low Endotoxin Recovery (LER) was investigated by observing
the change in particle sizes and activity of endotoxin in LER solutions containing sodium …

PURPOSE: Endotoxins, also called lipopolysaccharides (LPS), are major contaminants
found in commercially available proteins or biologically active substances, which often …

The inability to detect endotoxin using compendia methods is a potential safety concern for
patients due to the lack of endotoxin removal capabilities at the fill–finish stage in typical …