Janoshik result on a Zhuhai liraglutide lot lands 1.0 points below the supplier’s figure
The report states the gradient, the wavelength and the integration threshold, which is more than most.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Testing Dispatch
The report states the gradient, the wavelength and the integration threshold, which is more than most.
VendorInvestigate has released a batch of 9 analytical reports on research-grade cagrilintide lots, including material from SSA and KP. Reported purities range across roughly 4.4 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 97.6%, lowest 94.2%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 9 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.
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.
Sinéad Corrigan, patient advocate and former trial participant, 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."
SSA’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.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Parts per million sound impressive until they are converted into daltons at the molecular weight of the thing being measured.
What would make a difference is not a regulator. It is three lines on a certificate, all of which are already known to whoever wrote it.
The result is unremarkable. What the report omits is not.