Reproducibility, measured rather than assumed
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
Page 9 of 10 of this archive, newest first.
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 most useful single addition to any purity determination is a second separation under a different pH or on a different stationary phase, and the second-most useful is a…
Non-chromophoric components — counter-ions, salts, some excipients — contribute mass to the vial and nothing at all to the chromatogram.
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.
What a laboratory can and cannot know about the provenance, storage history and representativeness of what lands on its bench.
A blank certificate with the numbers left editable is an ordinary internal document. Its circulation as a finished record is the problem.
Lot-level verification with a public report is a real and achievable thing. It exists in this market, on a minority of listings.
What a laboratory can and cannot know about the provenance, storage history and representativeness of what lands on its bench.
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.
Two signatures — one who performed the work, one who approved its release — are the ordinary regulated convention and are almost unknown here.
The condition on arrival is recorded by some services and not others, and it is one of the more informative lines in a report.
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 Journal does not treat a badge as evidence and states so wherever it reports one.
What the Journal asks when a document arrives unsigned, and what the answers have been.
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.
A badge asserts that something was tested. It does not assert what, when, on whose sample, by what method, or whether the lot on sale is the lot that was tested.
Every third-party report in this market describes a sample somebody chose to send. That choice is outside the laboratory’s control and outside its records.
The most useful single addition to any purity determination is a second separation under a different pH or on a different stationary phase, and the second-most useful is a…
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.
What a laboratory can and cannot know about the provenance, storage history and representativeness of what lands on its bench.