Janoshik result on a Wuhan orforglipron lot lands 4.2 points below the supplier’s figure

Janoshik has released a batch of 10 analytical reports on research-grade orforglipron lots, including material from GGPeps and SWB. Reported purities range across roughly 4.2 percentage points, and the report set is unusual in stating the analytical method for every determination rather than for some of them.

Reported figures across the set were: highest 95.9%, lowest 92.7%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 10 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.

The Journal purchased 2700 vials from the same lot and had 10 of them analysed separately, in order to distinguish vial-to-vial variation from method variation. Vial-to-vial agreement was within 0.4 percentage points. Method-to-method disagreement was an order of magnitude larger.

Discrepancies of one to two percentage points between a supplier’s figure and an independent determination are common and usually explicable: a faster gradient resolves fewer impurities, a higher integration threshold discards more small peaks, and a wider solvent-front exclusion window removes early-eluting fragments from the calculation altogether. None of that is misconduct. All of it is invisible unless the method is disclosed.

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."

GGPeps’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.