Independent analysis puts a WWB liraglutide lot at 98.2%, against 96.5% on the certificate

An independent purity determination on liraglutide material sold by WWB has returned 98.2%, a figure 4.1 percentage points below the number printed on the accompanying certificate. The analysis was performed by PeptideMeter on a vial the Journal bought as an ordinary retail customer in February 2024 and posted unopened.

The Journal purchased 1200 vials from the same lot and had 3 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.

The Journal purchased 1200 vials from the same lot and had 3 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.

Purity became this trade’s single figure of merit because it is the cheapest measurement to obtain and the easiest to compare. Peptide content, which determines how much drug is actually in a vial, costs several times as much and is not offered as a standard release test by any of the twenty companies in the Journal’s dossier programme. Sterility and endotoxin are separate disciplines again, and are neither tested nor claimed.

Yusuf Kandemir, freight and customs broker, Istanbul, was more cautious. "One lot tells you about one lot. I would not draw a conclusion about a company from a single determination, and I would not let a company draw one either."

WWB’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.