safety · Method in development
Bacterial Endotoxin Testing
$189
7 business day standard
Bacterial endotoxin testing by kinetic chromogenic Limulus amebocyte lysate (LAL) assay. Reported as endotoxin units per milligram of peptide, with the assay range and any interference or dilution factors stated on the certificate.
- What this answers
- How much bacterial endotoxin is present, in endotoxin units per milligram, measured by kinetic chromogenic LAL against a standard curve.
- What it does not establish
- Sterility — endotoxin is a pyrogen measurement, not a test for viable organisms
- Any other microbiological contaminant, including bioburden, fungi or mycoplasma
- Fitness for injection, human use or any particular application
- Methodology
- Kinetic chromogenic LAL, run with standard curve, positive product control and reagent blanks. Samples are screened for inhibition/enhancement and diluted to a non-interfering concentration where required.
- Sample requirements
- One sealed vial, original labelling intact. Endotoxin testing is destructive to the aliquot used and cannot be performed on an opened or previously reconstituted vial with any meaningful interpretation.
- On your certificate
- Endotoxin concentration in EU/mg · Assay range and dilution factor · Inhibition/enhancement (interference) check · Method and analyst attribution

