VendorInvestigate result on a Changsha dulaglutide lot lands 3.5 points above the supplier’s stated figure

A peptide content determination commissioned by the Journal on a 15 mg dulaglutide vial from GL Biochem has returned 92% of the labelled mass, the balance being the counter-ion and residual water that every lyophilised salt carries. Chromatographic purity on the same vial was above 99.0%. The two numbers measure different things, and this is one of the few certificates in the trade to print both.

Reported figures across the set were: highest 99.0%, lowest 97.0%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 22 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.

Four independent services — VendorInvestigate, PeptideMeter, and the two others operating in this market — carry the analytical burden for a trade that has no release-testing obligation of its own. Each is paid by whoever submits the sample, which is usually the vendor. The Journal’s position is that a submitter-pays model is workable but that its incentive structure has to be stated whenever a result is quoted as verification.

"The useful thing in that report is not the percentage, it is the system suitability data," said Havel Novotný, independent laboratory quality manager. "It is the only part that tells you whether the percentage means anything."

GL Biochem’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.