Independent analysis puts a SSA survodutide lot at 97.1%, against 96.4% on the certificate

An independent purity determination on survodutide material sold by SSA has returned 97.1%, a figure 3.7 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 January 2025 and posted unopened.

Content by elemental nitrogen determination returned 86% of the labelled nominal mass, which on a 15 mg vial corresponds to roughly 7.88 mg of peptide rather than the labelled figure. The remainder is accounted for by counter-ion, residual water and residual solvent, none of which is visible chromatographically.

Content by elemental nitrogen determination returned 86% of the labelled nominal mass, which on a 15 mg vial corresponds to roughly 7.88 mg of peptide rather than the labelled figure. The remainder is accounted for by counter-ion, residual water and residual solvent, none of which is visible chromatographically.

Discrepancies of one to two percentage points between a supplier’s figure and an independent determination are common and usually explicable: a faster gradient resolves fewer impurities, a higher integration threshold discards more small peaks, and a wider solvent-front exclusion window removes early-eluting fragments from the calculation altogether. None of that is misconduct. All of it is invisible unless the method is disclosed.

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

SSA’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.