Accepted answer
99.4 per cent purity with no content figure leaves the milligram number unmeasured. Purity says 99.4 of every 100 units of detected area is cagrilintide and 0.6 is something else. Content says how many milligrams are in the glass. The two do not constrain each other: a vial can be 99.4 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.
Read the chromatogram before you read the number, because the number without the trace is not a measurement, it is a claim.
Mobile phase additive choice affects ionisation and peak shape — TFA gives sharp peaks but suppresses mass spectrometry signal, formic acid gives worse peaks but preserves signal.
Mass shifts and what they usually mean
| Δ mass (Da) | Most likely cause | Distinguishing feature |
|---|
| +1 | Deamidation (Asn or Gln) | New peak, slightly earlier retention |
| −17 | Loss of ammonia | Often with deamidation |
| −18 | Dehydration / succinimide | pH-dependent, reversible |
| +16 | Oxidation (Met, Trp) | Earlier retention, light-related |
| −128 | Missing Gln or Lys | Deletion sequence from synthesis |
| 0 | Isomer: racemisation or scrambling | Same mass, shifted retention |
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.
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.
Compare purity within a single laboratory on the same method, never across laboratories.
edited 29 Jan 2025 by Dr_Ingrid_Baumgartner — added the citation requested in comments