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 2800 vials from the same lot and had 9 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 useful thing in that report is not the percentage, it is the system suitability data," said Lorcan Feeney, analytical services director at an independent laboratory. "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.