What changed at SWB in February, and what the company says prompted it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Testing Dispatch
The supplier confirmed the determination and supplied the method behind its own figure inside a week.
Two laboratories analysing vials from the same semaglutide lot have returned figures 2.1 percentage points apart. VendorInvestigate reported 97.9%; PeptideMeter 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 97.9%, lowest 95.2%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 15 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 16 vials from the same lot at retail and had four 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.
Batch variance rather than vendor quality is the recurring finding of this programme. Across the 15 determinations the Journal has commissioned to date, within-vendor spread has been wider than between-vendor spread for two thirds of the companies tracked, which is an argument against rating any supplier on a single number.
"The useful thing in that report is not the percentage, it is the system suitability data," said Havel Novotný, independent laboratory quality manager. "It is the only part that tells you whether the percentage means anything."
QSC’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.
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.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
We set out what is known, what is inferred and what is simply assumed about the fortnight after a vial is opened.
A reminder that a purity figure is the output of a method, and that methods differ.