Independent analysis puts a SGN liraglutide lot at 97.4%, against 93.3% on the certificate

A peptide content determination commissioned by the Journal on a 10 mg liraglutide vial from SGN has returned 97% 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 97.4%. The two numbers measure different things, and this is one of the few certificates in the trade to print both.

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.

Reported figures across the set were: highest 97.4%, lowest 93.3%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 5 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.

The wider context is that material sold for research use carries no regulatory release specification in any jurisdiction the Journal has examined. A certificate is a commercial document, not a compliance one, and its content is whatever the issuer chooses to put on it. That is the gap independent testing fills, and it fills it imperfectly.

Dr Sirichai Boonmee, peptide chemist, Chulalongkorn University, said the gap was predictable from the methods alone. "You can reconstruct almost the whole difference from the integration threshold. What you cannot reconstruct is why anyone thinks a number without a threshold is comparable to a number with one."

SGN’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.