Janoshik result on a Qingdao dulaglutide lot lands 3.9 points above the supplier’s stated figure

Two laboratories analysing vials from the same dulaglutide lot have returned figures 3.9 percentage points apart. Janoshik reported 97.1%; Medutest reported a lower number on a shallower gradient with a tighter integration threshold. Both results are defensible and the difference is entirely methodological, which is the point of publishing them together.

Reported figures across the set were: highest 97.1%, lowest 93.6%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 11 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 97.1%, lowest 93.6%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 11 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 Sirichai Boonmee, peptide chemist, Chulalongkorn University. "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.