96.4 and 97.6 are 1.2 percentage points apart, which sounds small until you restate it as impurity. Medutest is leaving 3.6 per cent of the detected area unassigned and Janoshik 2.4 per cent — a factor of 1.5 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, 96.4 and 97.6 are two measurements of slightly different quantities that happen to share a unit.
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.
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.
Worth being precise here: 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.
Compare purity within a single laboratory on the same method, never across laboratories.
edited 14 Mar 2025 by a_lindgren — added the citation requested in comments
For what it is worth, my own independent result was within half a per cent of this. – micron22 5 months ago add a comment