Independent analysis puts a SSA orforglipron lot at 95.7%, against 92.2% on the certificate

VendorInvestigate has published a purity determination of 95.7% on a 30 mg vial of orforglipron supplied by SSA, against a figure of 92.2% on the certificate that accompanied the vial. The sample was submitted by the Journal in July 2024 as part of a continuing programme of arm’s-length purchasing, and the vendor was told before the order was placed that any result would be published.

The Journal purchased 3400 vials from the same lot and had 16 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 95.7%, lowest 92.2%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 16 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, Medutest, 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.

"Content is the number that matters if you are doing arithmetic with a vial, and content is the number nobody sells," said Havel Novotný, independent laboratory quality manager. "Purity is what you can afford. Content is what you need."

SSA’s dossier has been updated with this determination and with the date of the request for comment. The dossier’s "what we could not verify" box records the questions still outstanding.