JEEP names the synthesis and fill sites behind its catalogue
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 8 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.
Dr Wenjun Xie, process chemist and peptide manufacturing consultant, said the gap was predictable from the methods alone. "You can reconstruct almost the whole difference from the integration threshold. What you cannot reconstruct is why anyone thinks a number without a threshold is comparable to a number with one."
TFC’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.
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 states alongside it is not.