Research Peptide Quality Standards: What Good Looks Like

Per-lot documentation, not per-product

Quality is a property of a lot, not of a product name. A supplier that publishes one certificate for a catalogue item indefinitely is telling you nothing about the vial they ship you next month.

The baseline expectation is a certificate generated for each manufactured lot, retrievable by the lot number printed on the vial.

Testing scope

At minimum: HPLC purity with the chromatogram, mass spectrometric identity with the spectrum, and net peptide content. Depending on application, endotoxin, sterility, water content and residual solvent belong on the list as well.

• HPLC purity ≥99% with visible chromatogram
• Mass spectrometry identity confirmation
• Net peptide content determination
• Independent third-party laboratory
• Lot-level traceability from vial to certificate

Consistency and traceability

Consistency across lots is the hardest thing for a supplier to fake and the most useful thing for a laboratory. If purity, retention time and impurity profile look the same across three lots, the manufacturing process is under control.

Novanta releases every lot against independent HPLC and mass spectrometry data at 99%+ purity, with certificates published per lot and vials labelled so they can be matched back to the exact document.

Regulatory framing

Research-use-only material is not manufactured, labelled or intended for human or veterinary use, and no amount of testing changes that classification. Novanta is not a compounding pharmacy and supplies laboratory research chemicals only.