Accepted answer
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 tri_gly_ala — clarified the distinction between purity and content
The placebo-arm figure is the part everyone omits. – v_ramaswamy 5 months ago add a comment