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Endotoxin Testing for Peptides

Quantitative LAL assay per USP <85>, essential for injectable peptides and compounding pharmacies

Sensitivity down to 0.01 EU/mL using the Charles River Endosafe nexgen-PTS system

Last reviewed

Ready to test your peptides?

Send your peptide name, sample count, and the tests you need. We return a fixed-price quote, usually within one business day.

  • validated analytical methods, independent of any supplier
  • 9-11 business day standard turnaround
  • Traceable COA with chromatograms and method parameters

Why Endotoxin Testing Matters

Bacterial endotoxins are lipopolysaccharides (LPS) shed from gram-negative bacteria cell walls. They're heat-stable, meaning standard sterilization doesn't eliminate them. Even trace amounts can trigger dangerous pyrogenic responses in humans. For any peptide intended for injection, cell culture, or pharmaceutical compounding, endotoxin testing isn't optional, it's a safety requirement.

Quantitative LAL Assay

Kinetic chromogenic LAL method using Charles River Endosafe nexgen-PTS. Quantitative results with 0.01 EU/mL sensitivity: the most accurate method available.

USP <85> Compliant

Testing performed per USP <85> Bacterial Endotoxins Test guidelines. Results reported against all applicable limits for injectable, intrathecal, and research applications.

Comprehensive Panel

Combine endotoxin testing with heavy metal screening (ICP-MS) and residual solvent analysis (GC-MS) for a complete contaminant safety profile.

Endotoxin Limits by Application

ApplicationUSP LimitStandard
Injectable peptides< 5 EU/kg body weightUSP <85>
Intrathecal use< 0.2 EU/kg body weightUSP <85>
Cell culture research< 0.5 EU/mLRecommended
General research use< 20 EU/mLTypical spec

Testing Specifications

Endotoxin Testing (LAL)

  • Method: Kinetic chromogenic LAL assay
  • Instrument: Charles River Endosafe nexgen-PTS
  • Sensitivity: 0.01 EU/mL
  • Standards: USP <85>
  • Turnaround: 9–11 business days
  • Sample required: 1–5 mg

Comprehensive Contaminant Panel

  • Endotoxin: LAL assay (USP <85>)
  • Heavy metals: ICP-MS (Pb, Hg, As, Cd)
  • Residual solvents: GC-MS (ICH Q3C)
  • Combined report: Single COA
  • Turnaround: 9–11 business days
  • Sample required: 5–10 mg

Who Needs Endotoxin Testing?

Compounding Pharmacies (503A/503B)

FDA requires endotoxin testing for sterile compounded preparations. Our LAL testing provides USP-compliant documentation for pharmacy board inspections and 503B outsourcing facility requirements.

Research Institutions

Endotoxin contamination confounds cell-based assays, activates TLR4 signaling, and can invalidate in vivo study results. Verify your peptides are endotoxin-free before experiments.

Peptide Suppliers & Manufacturers

Provide endotoxin-free certificates to your customers. Independent LAL testing builds trust and differentiates your products from competitors who lack safety documentation.

Clinical Trial Sites

IND-enabling studies require endotoxin testing per FDA guidelines. Our quantitative LAL results meet regulatory submission requirements for investigational peptide products.

Endotoxin Testing FAQ

Get Quantitative Endotoxin Testing for Your Peptides

LAL assay per USP <85> with 0.01 EU/mL sensitivity, 9-11 business day turnaround, nationwide service.