Independent analysis puts a TFC liraglutide lot at 97.8%, against 94.8% on the certificate

Two laboratories analysing vials from the same liraglutide lot have returned figures 0.8 percentage points apart. Janoshik reported 97.8%; Medutest 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 20 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.

Reported figures across the set were: highest 97.8%, lowest 94.8%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 12 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 — Janoshik, 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.

"Ask for the suitability summary before you argue about the percentage," said Lorcan Feeney, analytical services director at an independent laboratory. "If the tailing factor and the replicate precision are outside limits, you are arguing about arithmetic performed on an unfit separation."

TFC’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.