Glossary
Endotoxin
Also called Bacterial endotoxin, LPS, Lipopolysaccharide, Pyrogen, LAL test
Fragments of bacterial cell walls that can cause fever, chills and flu-like reactions when injected. Sterilizing a product does not remove them, so they are tested for separately.
In more detail
Endotoxins are lipopolysaccharides from the outer membrane of certain bacteria. They can survive processes that kill the bacteria themselves. The standard test uses an extract from horseshoe crab blood cells (the LAL test), which reacts to endotoxin; FDA guidance covers how drug makers test for it.
A real example: FDA warned compounders after reports of severe chills, shaking, vomiting and fatigue following NAD+ injections made with an ingredient not suited to sterile use, symptoms consistent with endotoxin.
Why it matters
A peptide can be 99% pure and still carry endotoxin. If a COA has no endotoxin result, it simply was not tested. See How to read a peptide lab report (COA).
Related terms
- Certificate of analysis (COA)A document from a testing lab that reports what was measured in a sample: usually identity, purity and sometimes amount and contamination tests.
- Sterile techniqueThe set of habits that keep germs out of a vial, syringe and injection site: clean hands, swabbed stoppers and skin, new needles, and never touching anything that should stay sterile.
- HPLC purityThe share of the peptide signal in a sample that is the target peptide, measured by high-performance liquid chromatography. It is the percentage most COAs lead with.
Peptides where this comes up
Sources
Each source is labeled by where the information comes from. How we label sources
- RegulatoryGuidance for industry: Pyrogen and endotoxins testing, questions and answers(opens in a new tab)
FDA · checked
- Reference workLimulus amebocyte lysate(opens in a new tab)
Wikipedia · checked
- RegulatoryFDA reminds compounders to use ingredients suitable for sterile compounding(opens in a new tab)
FDA · checked
Updated