What We Offer
Testing Services
Comprehensive analytical testing to characterize, qualify, and release your peptide products with confidence.
Service 01
Purity Testing
How much peptide is really in your sample?
Purity is the foundation of every peptide specification. Our primary method is reverse-phase high-performance liquid chromatography (RP-HPLC), which separates the target peptide from synthesis-related impurities, truncated sequences, and degradation products so each can be measured.
Results are reported as percent purity by peak area, with a chromatogram and certificate of analysis. When identity or molecular-weight confirmation is required, we offer mass spectrometry (LC-MS) to verify the expected mass of your peptide.
What’s included
- Reverse-phase HPLC purity profile (% by area)
- Optional LC-MS identity and molecular-weight confirmation
- Annotated chromatogram with each resolved peak
- Certificate of analysis suitable for your records
Service 02
Sterility Testing
Is your sterile preparation truly free of contamination?
For injectable and other sterile peptide preparations, demonstrating the absence of viable microorganisms is non-negotiable. We perform sterility testing following USP <71> methodology, using membrane filtration or direct inoculation depending on the nature of your sample.
Inoculated media are incubated and observed across the compendial incubation period to detect bacterial and fungal growth. You receive a clear pass/fail result documented in a formal report.
What’s included
- Sterility testing per USP <71> methodology
- Membrane filtration or direct inoculation as appropriate
- Incubation across the full compendial observation period
- Documented pass/fail certificate of analysis
Service 03
Endotoxin Testing
Are pyrogens within safe limits?
Bacterial endotoxins (pyrogens) can cause serious adverse reactions even at trace levels in injectable products. We quantify endotoxin using the Limulus Amebocyte Lysate (LAL) bacterial endotoxins test (BET) in line with USP <85>.
Results are reported in endotoxin units per milligram (EU/mg) and compared against your applicable endotoxin limit, so you know immediately whether your product is within specification.
What’s included
- LAL / BET endotoxin quantification per USP <85>
- Results reported in EU/mg against your endotoxin limit
- Suitable for injectable and parenteral peptide products
- Formal certificate of analysis
Service 04
Heavy Metal Testing
Are elemental impurities within acceptable limits?
Trace heavy metals can enter peptide products from raw materials, reagents, catalysts, and manufacturing equipment. We measure elemental impurities by inductively coupled plasma mass spectrometry (ICP-MS) following the principles of USP <232> and <233> (and ICH Q3D).
Testing covers the key toxic elements — including lead, arsenic, cadmium, and mercury — with results reported against the applicable permitted daily exposure limits so you can confirm your product is safe and compliant.
What’s included
- Elemental impurities by ICP-MS per USP <232>/<233>
- Coverage of lead, arsenic, cadmium, mercury and more
- Results compared against permitted daily exposure limits
- Formal certificate of analysis
Not sure which tests you need?
Tell us about your product and intended use, and we will recommend the right testing panel.