Independent analysis puts a MKM liraglutide lot at 99.0%, against 97.4% on the certificate

Janoshik has published a purity determination of 99.0% on a 5 mg vial of liraglutide supplied by MKM, against a figure of 97.4% on the certificate that accompanied the vial. The sample was submitted by the Journal in March 2026 as part of a continuing programme of arm’s-length purchasing, and the vendor was told before the order was placed that any result would be published.

The Journal purchased 17 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.

Reported figures across the set were: highest 99.0%, lowest 97.4%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 9 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.

Batch variance rather than vendor quality is the recurring finding of this programme. Across the 9 determinations the Journal has commissioned to date, within-vendor spread has been wider than between-vendor spread for two thirds of the companies tracked, which is an argument against rating any supplier on a single number.

"The figure is not wrong and neither is theirs," said Havel Novotný, independent laboratory quality manager. "They are answers to two different questions and the trade has decided to pretend there is only one question. Print the gradient and the argument disappears."

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.