Evaluation of limulus amebocyte lysate and recombinant endotoxin alternative assays for an assessment of endotoxin detection specificity.

The United States Pharmacopeia (USP), European Pharmacopeia (EP), and Parenteral Drug Association (PDA) provide guidance on the validation of alternative microbiological methods (U.S. Pharmacopeia National Formulary 2019, Parenteral Drug Association Technical Report No.

Quality-control analytical methods: endtoxins: essential testing for pyrogens in the compounding laboratory, part 1.

Inadvertent exposure to endotoxins administered intravenously, intramuscularly, or intrathecally can cause a constellation of adverse effects that range from fever to multiple organ failure and death. Pharmacists who compound sterile formulations must remain exceptionally vigilant to guard against the contamination of such preparations with those pyrogens. Fortunately, endotoxin screening analyses are available for onsite use or from contract testing laboratories, and both options offer accurate, repeatable, and timely results.

Determination of endotoxin levels and their impact on interleukin-1 generation in continuous ambulatory peritoneal dialysis and hemodialysis.

Endotoxins represent a family of ubiquitous bacterial lipopolysaccharides found in water and raw materials. These substances have the ability to generate interleukin-1 (IL-1) and induce fever, as well as other acute phase phenomena. A study was undertaken to determine levels of background endotoxin in (1) continuous ambulatory peritoneal dialysis solution, (2) spent dialysate subsequent to overnight dwell, (3) hemodialysis solution, and (4) Limulus amebocyte lysate-reactive material (LAL-RM) in hemodialyzers and patient plasma.