Independent analysis puts a ERP survodutide lot at 95.6%, against 92.3% on the certificate

Janoshik has published a purity determination of 95.6% on a 10 mg vial of survodutide supplied by ERP, against a figure of 92.3% on the certificate that accompanied the vial. The sample was submitted by the Journal in October 2024 as part of a continuing programme of arm’s-length purchasing, and the vendor was told before the order was placed that any result would be published.

The Journal purchased 2800 vials from the same lot and had 22 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 95.6%, lowest 92.3%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 22 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.

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.

Lorcan Feeney, analytical services director at an independent laboratory, 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.