Independent analysis puts a MKM survodutide lot at 97.0%, against 95.7% on the certificate

An independent purity determination on survodutide material sold by MKM has returned 97.0%, a figure 3.3 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 VendorInvestigate on a vial the Journal bought as an ordinary retail customer in February 2024 and posted unopened.

The Journal purchased 20 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 97.0%, lowest 95.7%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 8 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.

Purity became this trade’s single figure of merit because it is the cheapest measurement to obtain and the easiest to compare. Peptide content, which determines how much drug is actually in a vial, costs several times as much and is quoted as a priced addition by most of the twenty companies in the Journal’s dossier programme rather than carried as a standard release test. Sterility and endotoxin are separate disciplines again, and are neither tested nor claimed.

Lorcan Feeney, analytical services director at an independent laboratory, was more cautious. "One lot tells you about one lot. I would not draw a conclusion about a company from a single determination, and I would not let a company draw one either."

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.