Endotoxin Testing for Peptides
— LAL Assay & Sterility
Bacterial endotoxins are one of the most serious safety concerns in research peptide products. Our LAL (Limulus Amebocyte Lysate) assay detects endotoxins with pass/fail results and precise numeric EU/mL values — the same standard used by pharmaceutical manufacturers worldwide.
What Is Endotoxin and Why Does It Matter?
Endotoxins are lipopolysaccharides (LPS) found in the outer membrane of gram-negative bacteria. Even trace amounts — invisible to the naked eye and undetectable by purity testing — can cause severe inflammatory reactions, fever, and septic shock when injected. Endotoxin contamination is a manufacturing process issue, not a purity issue; a peptide can be 99% pure and still have dangerous endotoxin levels.
For any peptide intended for subcutaneous or intramuscular injection, endotoxin testing is not optional — it is a fundamental safety requirement. Our LAL assay tests to FDA-recognized thresholds and reports numeric EU/mL values, not just pass/fail.
Safety Tests Available
Endotoxin (LAL Assay)
Kinetic turbidimetric LAL assay for bacterial endotoxin detection. Reports EU/mL with pass/fail versus relevant thresholds. Validated per USP <85> and EP 2.6.14.
Sterility Testing
Membrane filtration sterility assay per USP <71> detecting aerobic bacteria, anaerobic bacteria, and fungi. Required for injectable-grade products.
Heavy Metals Panel
ICP-MS analysis for lead, mercury, arsenic, and cadmium. Also available: expanded panel including chromium, nickel, and 20+ trace elements.
Residual Solvents
GC headspace analysis per ICH Q3C guidelines. Identifies Class 1, 2, and 3 solvents from synthesis or purification processes.
Who Needs Endotoxin Testing?
Add Endotoxin Testing to Your COA
Available as an add-on to any Purity + Identity panel or as part of our Full Safety Panel from $449.
Submit Your Sample