Independent analysis puts a ERP liraglutide lot at 99.4%, against 98.3% on the certificate

An independent purity determination on liraglutide material sold by ERP has returned 99.4%, a figure 2.9 percentage points below the number printed on the accompanying certificate. The analysis was performed by Janoshik on a vial the Journal bought as an ordinary retail customer in December 2024 and posted unopened.

The Journal purchased 800 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 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.

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."

ERP’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.