Janoshik result on a Zhuhai tirzepatide lot lands 2.5 points below the supplier’s figure

A peptide content determination commissioned by the Journal on a 30 mg tirzepatide vial from FGP has returned 92% of the labelled mass. Chromatographic purity on the same vial was above 98.6%. The two numbers measure different things and only one of them was on the certificate.

Reported figures across the set were: highest 98.6%, lowest 97.6%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 13 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 30 mg vial corresponds to roughly 7.18 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 figure is not wrong and neither is theirs," said Rowena Ashcombe, community pharmacist and diabetes educator. "They are answers to two different questions and the trade has decided to pretend there is only one question. Print the gradient and the argument disappears."

FGP’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.