Accepted answer
99.1 per cent purity with no content figure leaves the milligram number unmeasured. Purity says 99.1 of every 100 units of detected area is cagrilintide and 0.9 is something else. Content says how many milligrams are in the glass. The two do not constrain each other: a vial can be 99.1 per cent pure and still be under label, because water and counter-ion are part of the gross mass and neither shows up as an impurity peak. If you buy one test, buy the one that changes your arithmetic.
The relevant detail is that understanding purity requires separating the chemistry from the method from the reporting convention, and the three are not independent.
Column pore size affects mass transfer — a 100 Angstrom packing on a 5 kDa peptide restricts diffusion, broadening the peak and potentially hiding small impurities in the shoulders.
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 |
Integration of the shoulder — whether you use perpendicular drop or tangent skim — determines what area gets assigned to the main peak versus the impurity table.
Published side-by-side method comparisons show that a two-point difference in purity on the same vial is easily explained by method choice alone.
I would be careful about over-reading a single measurement — treat it as a data point, not as ground truth.
If you are ranking vendors, specify a method and have all samples tested at the same place.
Confirming from the other direction: I ignored the method section once and paid for it. – h_pergande 4 months ago Two of us submitted the same lot to different laboratories and got results a tenth apart. – tess_amankwah 2 months ago add a comment