Set the threshold at a tenth of a per cent and the small impurities vanish
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 6 of 10 of this archive, newest first.
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.
Duplicate submissions under different names test within-laboratory repeatability, which is a different quantity from between-laboratory reproducibility.
We describe each pathway in enough chemical detail to explain why it is invisible to the method the trade uses, because that is the part which has practical consequences.
The supplier has not disputed the finding. It has not explained the gap either.
Three compendial method families are in routine use and a fourth, based on a recombinant enzyme rather than crab lysate, is now compendial in its own right.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
A reminder that a purity figure is the output of a method, and that methods differ.
The supplier has not disputed the finding. It has not explained the gap either.
Every instrument specification quoted in an advertisement is a best case obtained on a calibration mixture, not on a submitted vial.
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.