What twenty companies say about storage, and what they have measured
A stability programme needs a protocol, defined conditions, a stability-indicating method and time. Time is the ingredient no commercial testing service can sell.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Testing Dispatch
The supplier has not disputed the finding. It has not explained the gap either.
Two laboratories analysing vials from the same orforglipron lot have returned figures 1.7 percentage points apart. PeptideMeter reported 98.7%; 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.
The Journal purchased 4200 vials from the same lot and had 20 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.
Reported figures across the set were: highest 98.7%, lowest 96.2%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 20 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.
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 Sinéad Corrigan, patient advocate and former trial participant. "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."
QYB’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.
A stability programme needs a protocol, defined conditions, a stability-indicating method and time. Time is the ingredient no commercial testing service can sell.
Reported from the analysis, not from a warning notice.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
None of what this piece asks for is commercially sensitive, and all of it is already known to whoever released the batch.
The interval between manufacture and analysis is the most under-read figure on the page, and the one most likely to matter by the time a vial is opened.
The result is unremarkable. What the report omits is not.