Accepted answer
97.9 and 98.8 are 0.9 percentage points apart, which sounds small until you restate it as impurity. Medutest is leaving 2.1 per cent of the detected area unassigned and Janoshik 1.2 per cent — a factor of 1.75 between them. The impurity fraction is the quantity that moves when a method changes, and it is the one worth arguing about; the headline is just its complement. Comparable means same column chemistry, same gradient slope, same detection wavelength, same integration convention. Until you have those four from both laboratories, 97.9 and 98.8 are two measurements of slightly different quantities that happen to share a unit.
To be exact about it, the single most important distinction is between what purity measures — the fraction of detected material that is your target — and what you actually want to know — how much of the material in the vial is your target.
The fraction of your main peak that is actually your target versus isomers, fragments or related sequences is invisible without complementary identity testing.
Reconciling gross mass to label claim
| Component | Typical share | Counted in purity? | Counted in content? |
|---|
| Target peptide | 88–94 % | Yes, as main peak | Yes |
| Related impurities | 1–3 % | Yes, as other peaks | No |
| Counter-ion (TFA or acetate) | 2–8 % | No | No |
| Residual water | 2–6 % | No | No |
| Bulking agent, if present | 0–40 % | No | No |
Gradient slope controls resolution, and gentler slopes resolve co-eluting impurities into separate peaks — so the better method reports the worse purity number.
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 26 Mar 2025 by mz_4113 — clarified the distinction between purity and content
This should be linked from the help pages. – v_ramaswamy 5 months ago add a comment