Why a 0.036-dalton difference is the hardest number in peptide identity
Every instrument specification quoted in an advertisement is a best case obtained on a calibration mixture, not on a submitted vial.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 20 of 27 of this archive, newest first.
Every instrument specification quoted in an advertisement is a best case obtained on a calibration mixture, not on a submitted vial.
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.
Peptide content is the number that tells you how much drug is in the vial. Almost nobody sells it, almost nobody buys it, and when we paid for it on nine vials the results…
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
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 absence of microbiological capability in this market is a commercial fact with a straightforward explanation, and it is worth understanding before blaming anybody for it.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
Column chemistry, particle size and pore diameter determine what the separation is capable of before the gradient is even programmed.
The result is unremarkable. What the report omits is not.
A brief and unromantic tour of the interface between a liquid sample and a vacuum.
The result is unremarkable. What the report omits is not.
The Journal has read several hundred certificates from twenty companies. We set out what the documents actually cover, and what a reader is filling in from imagination.
A result on one vial generalises to a batch only if the vial was drawn in a way that makes it representative — and nobody records how it was drawn.
A document is only as good as the chain that connects it to the material, and most chains here are two or three links longer than the paperwork admits.
Every step between the laboratory report and the product page removes information, and the badge is the last step.
The result is unremarkable. What the report omits is not.
An orthogonal method separates on a different physical principle, so that species co-eluting in the first are likely to resolve in the second. Two runs of the same method at…
The limit for a parenteral product is calculable from the dose and the body weight in two lines. Almost nobody in this trade performs the calculation.
A shallow gradient resolves impurities that a steep one runs into the parent peak. Both methods are legitimate; only one of them can see the small stuff.
A reminder that a purity figure is the output of a method, and that methods differ.