France health authority warns on falsified tirzepatide pens
Reported from the analysis, not from a warning notice.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Testing Dispatch
The supplier confirmed the determination and supplied the method behind its own figure inside a week.
Two laboratories analysing vials from the same semaglutide lot have returned figures 1.9 percentage points apart. PeptideMeter reported 96.0%; VendorInvestigate reported a lower number on a shallower gradient with a tighter integration threshold. Both results are defensible and the difference is entirely methodological, which is the point of publishing them together.
Reported figures across the set were: highest 96.0%, lowest 94.2%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 9 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 92% of the labelled nominal mass, which on a 2 mg vial corresponds to roughly 8.29 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 — PeptideMeter, 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 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."
JEEP’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.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
The Journal does not treat a badge as evidence and states so wherever it reports one.
A reminder that a purity figure is the output of a method, and that methods differ.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
We describe each pathway in enough chemical detail to explain why it is invisible to the method the trade uses, because that is the part which has practical consequences.