The Panel
What we test for, and how.
Each method below is run per-lot. Limits reflect our internal release specification — typically tighter than pharmacopeial minimums.
RP-HPLC
Reverse-phase HPLC with UV/DAD detection quantifies the target peptide against impurities and process residuals.
- Release limit
- ≥ 99.0%
- Instrument
- Agilent 1260 Infinity II
ESI / MALDI-MS
Mass spectrometry confirms exact molecular weight and detects any truncated or modified sequences.
- Release limit
- ± 0.1 Da of theoretical
- Instrument
- Thermo Q Exactive
Amino Acid Analysis
Acid hydrolysis followed by amino acid quantification verifies the composition matches the declared sequence.
- Release limit
- Sequence-confirmed
- Instrument
- Hitachi L-8900
Karl Fischer
Coulometric titration measures residual moisture in the lyophilized cake — critical for stability and reconstitution accuracy.
- Release limit
- ≤ 6.0%
- Instrument
- Mettler Toledo V20
GC-Headspace
Screens for residual acetonitrile, methanol, DMF, and other process solvents below pharmacopeial thresholds.
- Release limit
- ICH Q3C class limits
- Instrument
- Agilent 8890 GC
LAL Endotoxin
Limulus amebocyte lysate assay quantifies bacterial endotoxin levels for cell-culture compatibility.
- Release limit
- < 5 EU/mg
- Instrument
- Charles River Endosafe
USP <71> Sterility
Membrane filtration into fluid thioglycollate and tryptic soy broth, incubated and inspected per USP <71>.
- Release limit
- No growth at 14 days
- Instrument
- Membrane filtration
Chain of Custody
From synthesis to shelf, every sample is tracked.
Each lot is assigned a unique identifier at the point of synthesis. That ID follows the material through purification, lyophilization, fill, and every test point — and is printed on the vial label and the COA. Anyone can verify the chain via the lot lookup tool.
- LOT-2487
Synthesis complete
SPPS, 32 cycles
- LOT-2487
RP-HPLC purification
Pooled fractions ≥ 99.4%
- LOT-2487
Lyophilization
Residual H₂O 3.1%
- LOT-2487
ISO 17025 release panel
All assays pass
- LOT-2487
Fill & seal
Argon-purged headspace
- LOT-2487
COA published
Available on product page
FAQ
Common questions about our testing
Who performs the testing?
Independent laboratories accredited to ISO/IEC 17025 perform identity, purity, and contamination assays. Our internal QC repeats HPLC on every lot as a release gate.
When is the COA published?
Before the lot is released to fulfillment. If a lot has no COA on its product page, it cannot ship.
What happens if a batch fails?
It is quarantined and destroyed. We do not downgrade, re-sell, or sub-brand failed material.
Can I see raw chromatograms?
Yes — every published COA links to the full HPLC trace and mass spectrum as PDFs.
