Reproducibility, measured rather than assumed
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.
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 tirzepatide lot have returned figures 1.1 percentage points apart. VendorInvestigate reported 98.3%; 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 2700 vials from the same lot and had 13 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.
The Journal purchased 2700 vials from the same lot and had 13 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 13 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.
"Content is the number that matters if you are doing arithmetic with a vial, and content is the number nobody sells," said Yusuf Kandemir, freight and customs broker, Istanbul. "Purity is what you can afford. Content is what you need."
SWB’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 Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.
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.
Somebody has to be answerable for a release document. On most certificates in this market, nobody is named at all.
Two signatures — one who performed the work, one who approved its release — are the ordinary regulated convention and are almost unknown here.
Every step between the laboratory report and the product page removes information, and the badge is the last step.