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 …

Endotoxins are the major contributors to the pyrogenic response caused by contaminated
pharmaceutical products, formulation ingredients, and medical devices. Recombinant …

The measurement of low levels of bacterial lipopolysaccharides (endotoxins) in protein
samples can be a challenge due to potential interference from the inherent properties of the …

Prior to testing for the presence of bacterial endotoxin, parenteral products are handled and
stored in a variety of ways. Two incidents, detected by the US Food and Drug Administration …

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

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

Since the mid-1970s the Limulus Amebocyte Lysate (LAL) assay has been used to test
medical devices for bacterial endotoxins. The Association for the Advancement of Medical …

For release of parenteral drug products, bacterial endotoxin testing is one of a panel of
necessary tests. In order to ensure the validity of such tests, various controls are performed …

A quantitative, sensitive, and reproducible kinetic turbidimetric adaptation of the Limulus
amebocyte lysate (LAL) assay was used to assess endotoxin adsorption/recovery from …

A phenomenon initially reported by Chen and Vinther in 2013 [1], and now commonly
referred to as low endotoxin recovery (LER), has prompted the Food and Drug …