JEEP declines, for the 20th 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.
VendorInvestigate has released a batch of 15 analytical reports on research-grade tirzepatide lots, including material from TFC and ERP. Reported purities range across roughly 2.6 percentage points, and the report set is unusual in stating the analytical method for every determination rather than for some of them.
The Journal purchased 3100 vials from the same lot and had 15 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.
"Content is the number that matters if you are doing arithmetic with a vial, and content is the number nobody sells," said Havel Novotný, independent laboratory quality manager. "Purity is what you can afford. Content is what you need."
TFC’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.
The Journal’s standing position: a mass that matches is necessary evidence of identity and nowhere near sufficient.
Deamidation adds 0.98 daltons. On a low-resolution instrument at incretin molecular weights, that is inside the noise.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Calibration drift is real, unremarkable, and the reason serious laboratories run internal standards.
The result is unremarkable. What the report omits is not.