VendorInvestigate result on a Chengdu cagrilintide lot lands 3.1 points above the supplier’s stated figure

A peptide content determination commissioned by the Journal on a 5 mg cagrilintide vial from ERP has returned 94% of the labelled mass, the balance being the counter-ion and residual water that every lyophilised salt carries. Chromatographic purity on the same vial was above 97.6%. The two numbers measure different things, and this is one of the few certificates in the trade to print both.

Reported figures across the set were: highest 97.6%, lowest 94.4%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 17 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.

Reported figures across the set were: highest 97.6%, lowest 94.4%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 17 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.

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.

"The gap that matters is not between the two laboratories, it is between either of them and the certificate," said Dr Emiko Tanabe, mass spectrometrist. "One of those documents states a method. Compare like with like and most of this disappears."

ERP’s dossier has been updated with this determination and with the company’s response to it. The dossier’s ordering box records the lead times, the minimum quantities and what a buyer should ask for at the point of order.