Independent analysis puts a MKM liraglutide lot at 96.2%, against 94.9% on the certificate

An independent purity determination on liraglutide material sold by MKM has returned 96.2%, a figure 3.0 percentage points below the number printed on the accompanying certificate. The analysis was performed by Medutest on a vial the Journal bought as an ordinary retail customer in March 2025 and posted unopened.

The Journal purchased 3600 vials from the same lot and had 11 of them analysed separately, in order to distinguish vial-to-vial variation from method variation. Vial-to-vial agreement was within 0.4 percentage points. Method-to-method disagreement was an order of magnitude larger.

Discrepancies of one to two percentage points between a supplier’s figure and an independent determination are common and usually explicable: a faster gradient resolves fewer impurities, a higher integration threshold discards more small peaks, and a wider solvent-front exclusion window removes early-eluting fragments from the calculation altogether. None of that is misconduct. All of it is invisible unless the method is disclosed.

"The useful thing in that report is not the percentage, it is the system suitability data," said Havel Novotný, independent laboratory quality manager. "It is the only part that tells you whether the percentage means anything."

MKM’s dossier has been updated with this determination and with the date of the request for comment. The dossier’s "what we could not verify" box records the questions still outstanding.