Independent analysis puts a QYB survodutide lot at 95.9%, against 94.3% on the certificate

A peptide content determination commissioned by the Journal on a 10 mg survodutide vial from QYB has returned 94% 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 95.9%. The two numbers measure different things, and this is one of the few certificates in the trade to print both.

The Journal purchased 17 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 95.9%, lowest 94.3%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 12 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.

"Content is the number that matters if you are doing arithmetic with a vial, and content is the number nobody sells," said Dr Sirichai Boonmee, peptide chemist, Chulalongkorn University. "Purity is what you can afford. Content is what you need."

QYB’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.