Independent analysis puts a HJ dulaglutide lot at 95.0%, against 93.3% on the certificate

A peptide content determination commissioned by the Journal on a 5 mg dulaglutide vial from HJ has returned 93% of the labelled mass, the balance being the counter-ion and residual water that every lyophilised salt carries. Chromatographic purity on the same vial was above 95.0%. The two numbers measure different things, and this is one of the few certificates in the trade to print both.

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.

Four independent services — Janoshik, PeptideMeter, 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 Dr Beatriz Sarmiento, clinical pharmacologist, Universidad de Navarra. "It is the only part that tells you whether the percentage means anything."

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.