What counts as total, and who decided
We work through a single chromatogram twice, under two integration conventions, and show where the difference comes from.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 13 of 27 of this archive, newest first.
We work through a single chromatogram twice, under two integration conventions, and show where the difference comes from.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
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.
The purity figure is the least informative line on a well-constructed certificate and the only line most buyers read.
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…
The result is unremarkable. What the report omits is not.
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.
A reminder that a purity figure is the output of a method, and that methods differ.
The Journal has read several hundred certificates from twenty companies. The number is almost always there; the method behind it almost never is.
The result is unremarkable. What the report omits is not.
Lot-level verification with a public report is a real and achievable thing. It exists in this market, on a minority of listings.
An assay against a quantitative reference standard measures how much is present. Area per cent measures what proportion of the visible material is the parent. Only the first…
Regulated pharmaceutical practice has explicit reporting, identification and qualification thresholds. This trade has none, which is why a purity figure carries no…
Calibration drift is real, unremarkable, and the reason serious laboratories run internal standards.
Stereochemical inversion changes the molecule, changes its biology, and changes its mass by exactly nothing.
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.
Lot-level verification with a public report is a real and achievable thing. It exists in this market, on a minority of listings.
Chain of custody, in a regulated setting, begins at sampling. Here it begins when the package arrives.