Accepted answer
3 percentage points, and the direction is the informative half. Medutest reports 99.4 per cent and the certificate 96.4, so the independent figure is higher. As impurity that is 0.6 per cent against 3.6 — 0.17 times as much unassigned area, which is the unusual direction and worth a second look at the integration. Method differences usually make the independent number the lower one, so an independent result above the certificate points at integration limits, a different wavelength, or a different definition of the main peak rather than at a better vial. Ask both parties for the method section before you decide which figure is wrong, because the answer is often neither.
Read the chromatogram before you read the number, because the number without the trace is not a measurement, it is a claim.
Buffer versus acid in the mobile phase changes the ionisation state of basic and acidic residues, shifting retention and selectivity — same vial, potentially different separation.
Concretely, retention time is sequence-specific and method-specific, so comparing your result to a supplier value using a different method is meaningless without method documentation.
The ICH Q3A impurity thresholds and the relevant pharmacopoeial chapters all specify method validation requirements that almost no research-grade certificate claims to meet.
One qualification: achieving purity above roughly 98 per cent on a 30-residue peptide is fighting the chemistry of synthesis, not the quality of the purification.
If you are ranking vendors, specify a method and have all samples tested at the same place.
edited 31 Jan 2025 by tobias_reint — added the citation requested in comments
3Which wavelength was the purity integrated at? It changes the number more than people think. – tandem_gradient 7 months ago 2For what it is worth, my own independent result was within half a per cent of this. – tess_amankwah 6 months ago add a comment