Canada health authority warns on falsified dulaglutide pens
Reported from the analysis, not from a warning notice.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Testing Dispatch
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Janoshik has published a purity determination of 97.7% on a 10 mg vial of tirzepatide supplied by QSC, against a figure of 95.7% on the certificate that accompanied the vial. The sample was submitted by the Journal in April 2025 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.
Reported figures across the set were: highest 97.7%, lowest 95.7%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 5 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.
Content by elemental nitrogen determination returned 95% of the labelled nominal mass, which on a 10 mg vial corresponds to roughly 4.73 mg of peptide rather than the labelled figure. The remainder is accounted for by counter-ion, residual water and residual solvent, none of which is visible chromatographically.
Four independent services — Janoshik, VendorInvestigate, 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 gap that matters is not between the two laboratories, it is between either of them and the certificate," said Dr Sirichai Boonmee, peptide chemist, Chulalongkorn University. "One of those documents states a method. Compare like with like and most of this disappears."QSC’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.
Reported from the analysis, not from a warning notice.
What would be needed to catch each of these, and what it would cost.
Duplicate submissions under different names test within-laboratory repeatability, which is a different quantity from between-laboratory reproducibility.
A reminder that a purity figure is the output of a method, and that methods differ.
The interval between manufacture and analysis is the most under-read figure on the page, and the one most likely to matter by the time a vial is opened.
What the Journal asks when a document arrives unsigned, and what the answers have been.