SGN 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.
Two laboratories analysing vials from the same mazdutide lot have returned figures 2.4 percentage points apart. Medutest reported 99.2%; 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 18 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.
Purity became this trade’s single figure of merit because it is the cheapest measurement to obtain and the easiest to compare. Peptide content, which determines how much drug is actually in a vial, costs several times as much and is quoted as a priced addition by most of the twenty companies in the Journal’s dossier programme rather than carried as a standard release test. Sterility and endotoxin are separate disciplines again, and are neither tested nor claimed.
"Content is the number that matters if you are doing arithmetic with a vial, and content is the number nobody sells," said Dr Emiko Tanabe, mass spectrometrist. "Purity is what you can afford. Content is what you need."
SGN’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.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
An in-use period is established by a dedicated study on a specific formulation in a specific container at a specific concentration. Borrowing one from a marketed product is…
We submitted vials for endotoxin determination and report the results, the method and the laboratory, because a pyrogen figure without a method is as empty as a purity…
The purity figure is the least informative line on a well-constructed certificate and the only line most buyers read.
A reminder that a purity figure is the output of a method, and that methods differ.