A chromatogram supplied as a small image is legible for peak shape and not for baseline detail. That is enough to sanity-check an integration and not enough to reproduce it.
What a certificate commits its issuer to
Coming back to post #14, because the follow-up matters more than the original answer.
A certificate of analysis is a statement by its issuer that a defined test was performed on a defined lot and produced a defined result. That is all it is, and it is not nothing. What makes it usable: lot identifier matching the container, test date, method identification specific enough to reproduce, the actual result as a number, and the acceptance criterion stated separately from the result.
Peptide content and chromatographic purity are separate determinations and a certificate that reports only one has answered only one question. Content is the one that tells you how much is in the vial.
Someone will know this better than I do and I hope they say so.
Residual solvent screening is not standard on these documents and its presence is a signal about the manufacturer's own systems rather than about the vial.
Posting it because the silence on this was starting to look like agreement.
Coming back to post #33, because the follow-up matters more than the original answer.
A chromatogram supplied as a small image is legible for peak shape and not for baseline detail. That is enough to sanity-check an integration and not enough to reproduce it.
I would call that likely rather than established.
A chromatogram supplied as a small image is legible for peak shape and not for baseline detail. That is enough to sanity-check an integration and not enough to reproduce it.
That has held every time I have looked, which is not the same as always.
What fields matter on a certificate: lot number matching the vial, test date, the analytical method stated specifically, the measured result as a number, and the acceptance limit stated separately. A certificate missing any of these is weaker.
This has been discussed before and I could not find the thread, so, again.
Post #104 describes the usual case. This is about the unusual one.
Asking for the batch record rather than the certificate is a reasonable request and the response to it is informative whichever way it goes.
If anyone has run this properly I would rather read that than my own guess.
An itemised related-substances table with retention times says considerably more about the synthesis than a single total. A total tells you how much is not the main peak and nothing about what it is.
The right answer here may simply be that it has not been measured.
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- Second pass at: Certificates issued by the seller versus by a laboratoryAnalytics › COA interpretation · 92 replies
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