Independent analysis puts a ERP cagrilintide lot at 95.3%, against 91.4% on the certificate

An independent purity determination on cagrilintide material sold by ERP has returned 95.3%, a figure 0.9 percentage points below the number printed on the accompanying certificate. The analysis was performed by VendorInvestigate on a vial the Journal bought as an ordinary retail customer in July 2024 and posted unopened.

Content by elemental nitrogen determination returned 91% of the labelled nominal mass, which on a 5 mg vial corresponds to roughly 10.39 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 Yusuf Kandemir, freight and customs broker, Istanbul. "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."

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.