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

A peptide content determination commissioned by the Journal on a 5 mg cagrilintide vial from ERP has returned 88% of the labelled mass. Chromatographic purity on the same vial was above 97.6%. The two numbers measure different things and only one of them was on the certificate.

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.

Alastair Renshaw, pharmaceutical supply-chain consultant, 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."

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.