Sterility is not a percentage, which is the whole difficulty
Every certificate circulating in this market answers a question about molecules. Almost none answers a question about organisms, pyrogens, or the integrity of the seal.
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 cagrilintide lot have returned figures 0.7 percentage points apart. VendorInvestigate reported 98.3%; 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 98.3%, lowest 94.9%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 21 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 9 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.
Four independent services — VendorInvestigate, PeptideMeter, 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.
Dr Wenjun Xie, process chemist and peptide manufacturing consultant, wanted the wavelength printed. "A method reading at 280 nanometres cannot see a fragment that has lost its aromatic residue. That is not a failure of the laboratory, it is a fact about the question they were asked."QYB’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.
Every certificate circulating in this market answers a question about molecules. Almost none answers a question about organisms, pyrogens, or the integrity of the seal.
Follow the resin, not the catalogue.
Follow the resin, not the catalogue.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
A reminder that a purity figure is the output of a method, and that methods differ.
The Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.