We split six vials four ways and posted them
Two years ago we ran an anonymised version of this comparison and promised a named one. This is it, with every method printed in full.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
HPLC, mass spectrometry, and the certificate of analysis.
Two years ago we ran an anonymised version of this comparison and promised a named one. This is it, with every method printed in full.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
A reminder that a purity figure is the output of a method, and that methods differ.
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 report states the gradient, the wavelength and the integration threshold, which is more than most.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Deamidation adds 0.98 daltons. On a low-resolution instrument at incretin molecular weights, that is inside the noise.
Purity, content, identity, sterility and endotoxin are five separate determinations. A single sheet of paper carrying one of them is not evidence about the other four.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
An isoaspartate rearrangement changes the molecule and not the mass. A method that confirms identity by molecular weight alone will report it as the parent compound.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Somebody has to be answerable for a release document. On most certificates in this market, nobody is named at all.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
We asked twenty companies three questions about stability data and print every answer, refusal and non-response.
The result is unremarkable. What the report omits is not.
A reminder that a purity figure is the output of a method, and that methods differ.
A reminder that a purity figure is the output of a method, and that methods differ.
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.
Calibration drift is real, unremarkable, and the reason serious laboratories run internal standards.