Medutest result on a Xi'an semaglutide lot lands 3.3 points above the supplier’s stated figure

Medutest has released a batch of 9 analytical reports on research-grade semaglutide lots, including material from ERP and KP. Reported purities range across roughly 3.3 percentage points, and the report set is unusual in stating the analytical method for every determination rather than for some of them.

Reported figures across the set were: highest 98.4%, lowest 94.3%, 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.

The Journal purchased 9 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.

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.

Marek Doležal, analytical chemist and former QC laboratory manager, 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."

ERP’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.