Independent analysis puts a SSA orforglipron lot at 95.7%, against 92.2% on the certificate
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 21 of 25 of this archive, newest first.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Endotoxin is the more tractable of the two questions, and a kinetic chromogenic determination is neither slow nor exotic. It is simply not on the menu.
The supplier has not disputed the finding. It has not explained the gap either.
A reminder that a purity figure is the output of a method, and that methods differ.
The condition on arrival is recorded by some services and not others, and it is one of the more informative lines in a report.
The interval between manufacture and analysis is the most under-read figure on the page, and the one most likely to matter by the time a vial is opened.
The result is unremarkable. What the report omits is not.
At low concentrations a measurable fraction of peptide can adsorb to glass and plastic surfaces, and the loss is largest exactly where it is least expected.
The supplier has not disputed the finding. It has not explained the gap either.
We work through a single chromatogram twice, under two integration conventions, and show where the difference comes from.
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
The supplier has not disputed the finding. It has not explained the gap either.
What would make a difference is not a regulator. It is three lines on a certificate, all of which are already known to whoever wrote it.
Storage instructions in this market are close to uniform and almost never accompanied by the study that would justify them. Uniformity is a sign of convention, not of…
A reminder that a purity figure is the output of a method, and that methods differ.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
The supplier has not disputed the finding. It has not explained the gap either.
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.
The purity figure is the least informative line on a well-constructed certificate and the only line most buyers read.
The supplier has not disputed the finding. It has not explained the gap either.