Medutest result on a Hangzhou dulaglutide lot lands 3.0 points above the supplier’s stated figure

An independent purity determination on dulaglutide material sold by ERP has returned 99.3%, 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 January 2025 and posted unopened.

Reported figures across the set were: highest 99.3%, lowest 97.9%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 15 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.

Reported figures across the set were: highest 99.3%, lowest 97.9%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 15 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.

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.

Havel Novotný, independent laboratory quality 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.