Two ways to lift a peptide into a vacuum, and why the answer differs
The ionisation method determines the charge states you see, the adducts you must account for, and the modifications you might destroy in the process.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 39 of 51 of this archive, newest first.
The ionisation method determines the charge states you see, the adducts you must account for, and the modifications you might destroy in the process.
Reported from the analysis, not from a warning notice.
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.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.
Reported from the analysis, not from a warning notice.
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.
Reported from the analysis, not from a warning notice.
Reversed-phase chromatography runs in an organic, acidic mobile phase that dissociates most non-covalent aggregates on the way to the detector.
A blank certificate with the numbers left editable is an ordinary internal document. Its circulation as a finished record is the problem.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
A brief and unromantic tour of the interface between a liquid sample and a vacuum.
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.
Lyophilisation does not stop degradation. It slows every pathway by removing the solvent that most of them require, and the residue of solvent that remains sets the rate.
Reported from the analysis, not from a warning notice.
The Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.
Reported from the analysis, not from a warning notice.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Reported from the analysis, not from a warning notice.