Method
Bacterial endotoxin
Endotoxin tests look for lipopolysaccharide from gram-negative bacteria. They do not count living organisms, and they do not identify the peptide.
Laboratories often use a limulus amebocyte lysate assay, sometimes kinetic, sometimes named alongside USP <85>. A result in endotoxin units per vial or per milliliter is meaningful only with the unit and the sample amount. “Pass” without a limit, a unit, or a method is a thinner record.
Some menus list an endotoxin screen and do not name LAL or any compendial chapter. Keep that distinction. “Screen” means the laboratory offered a test under that word. It does not tell you which assay ran.
Endotoxin can be present when a sterility test would not find viable cells, and viable cells can be a question when an endotoxin number is low. Read the sterility and microbial page before treating one line as the other.
An endotoxin result is an analytical number on a research sample. It is not a statement that a material is suitable for use in people or animals. Specifications, when a laboratory uses them, are the laboratory’s acceptance limits for the test it ran.