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 above the number printed on the accompanying certificate, which the supplier had reported against a shorter gradient and a tighter threshold. 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 14 vials from the same lot at retail and had four 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.

"Ask for the suitability summary before you argue about the percentage," said Dr Beatriz Sarmiento, clinical pharmacologist, Universidad de Navarra. "If the tailing factor and the replicate precision are outside limits, you are arguing about arithmetic performed on an unfit separation."

MKM’s dossier has been updated with this determination and with the company’s response to it. The dossier’s ordering box records the lead times, the minimum quantities and what a buyer should ask for at the point of order.