Janoshik result on a Wuxi survodutide lot lands 2.9 points below the supplier’s figure

A peptide content determination commissioned by the Journal on a 15 mg survodutide vial from MKM has returned 87% of the labelled mass. Chromatographic purity on the same vial was above 97.1%. The two numbers measure different things and only one of them was on the certificate.

Reported figures across the set were: highest 97.1%, lowest 95.2%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 14 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.

Content by elemental nitrogen determination returned 87% of the labelled nominal mass, which on a 15 mg vial corresponds to roughly 6.38 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.

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.

"The figure is not wrong and neither is theirs," said Sinéad Corrigan, patient advocate and former trial participant. "They are answers to two different questions and the trade has decided to pretend there is only one question. Print the gradient and the argument disappears."

MKM’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.