The relevant detail is that reporting threshold is convention and not chemistry, which is why two certificates with different thresholds disagree by a tenth of a point or more.
Temperature affects the dynamics of molecular conformation, and if a peptide has proline residues that interconvert on the chromatographic timescale, the peak will split or shoulder at low temperature and collapse at high temperature.
It helps to be literal here: sample solvent strength affects peak shape — if you inject in strong solvent on a gradient starting in weak solvent, the solvent peak can distort your main peak or create a false shoulder.
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.
The limitation is that single-digit micro-impurities become invisible at typical reporting thresholds, so "no impurities detected" means "none above one in two thousand."
Compare purity within a single laboratory on the same method, never across laboratories.
edited 19 May 2026 by Dr_Jonas_Halvorsen — updated for the 2026 guidance change
4This matches what I was told by a laboratory, for whatever that is worth. – Dr_Tomas_Kral 6 months ago 3Minor: the trial name is hyphenated in the original publication. – forty_two_c 4 months ago add a comment