Endotoxin
A toxic component of gram-negative bacterial cell walls (lipopolysaccharide). Endotoxin contamination in peptide preparations can cause fever, inflammation, and sepsis. Pharmaceutical-grade peptides are tested to be below endotoxin limits.
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Related Terms
Any substance that causes fever when introduced into the body. Endotoxins are the most common pyrogens in pharmaceutical products. Peptides must be tested and confirmed to be pyrogen-free.
Endotoxin testingLaboratory analysis (typically Limulus Amebocyte Lysate or LAL test) to detect and quantify bacterial endotoxins in peptide products. FDA limits are typically <5 EU/kg body weight for injectable products.
GMP (good manufacturing practice)A system of quality assurance standards ensuring products are consistently produced and controlled according to defined quality standards. GMP-grade peptides meet pharmaceutical manufacturing requirements.