Independent analysis puts a WWB survodutide lot at 99.0%, against 97.4% on the certificate
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Testing Dispatch
VendorInvestigate result on a Shanghai dulaglutide lot lands 2.0 points above the supplier’s stated figure
The result is unremarkable. What the report states alongside it is not.
An independent purity determination on dulaglutide material sold by SGN has returned 96.7%, a figure 2.0 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 VendorInvestigate on a vial the Journal bought as an ordinary retail customer in December 2024 and posted unopened.
Reported figures across the set were: highest 96.7%, lowest 92.6%, 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.
The Journal purchased 10 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.
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.
"The gap that matters is not between the two laboratories, it is between either of them and the certificate," said Lorcan Feeney, analytical services director at an independent laboratory. "One of those documents states a method. Compare like with like and most of this disappears."SGN’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.
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