QYB declines, for the 10th time, to name its synthesis house
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 report states the gradient, the wavelength and the integration threshold, which is more than most.
Two laboratories analysing vials from the same orforglipron lot have returned figures 2.5 percentage points apart. Medutest reported 97.4%; VendorInvestigate 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 4000 vials from the same lot and had 14 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.
Four independent services — Medutest, VendorInvestigate, and the two others operating in this market — carry the analytical burden for a trade that has no release-testing obligation of its own. Each is paid by whoever submits the sample, which is usually the vendor. The Journal’s position is that a submitter-pays model is workable but that its incentive structure has to be stated whenever a result is quoted as verification.
"The figure is not wrong and neither is theirs," said Havel Novotný, independent laboratory quality manager. "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."
ERP’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.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
We set out what the cycle does, in order, so that a reader can see which of its steps a rushed operation shortens first.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The limit for a parenteral product is calculable from the dose and the body weight in two lines. Almost nobody in this trade performs the calculation.
The result is unremarkable. What the report omits is not.
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.