Independent analysis puts a HJ tirzepatide lot at 97.3%, against 94.2% on the certificate

Two laboratories analysing vials from the same tirzepatide lot have returned figures 2.0 percentage points apart. VendorInvestigate reported 97.3%; PeptideMeter 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.

The Journal purchased 12 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.

Content by elemental nitrogen determination returned 93% of the labelled nominal mass, which on a 5 mg vial corresponds to roughly 5.57 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.

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.

Dr Beatriz Sarmiento, clinical pharmacologist, Universidad de Navarra, thought the split-sample design was the useful part. "A single result on a single vial is an anecdote with a decimal point. Pairs from one lot to two laboratories is the cheapest experiment that answers a real question."

HJ’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.