A checklist for reading a certificate in under two minutes — does this still hold?
Sterility testing is separate: chromatographic purity, mass spectrometry, and endotoxin testing all say nothing about whether a solution is sterile. If sterility matters, it needs to be tested and reported.
Having read the exchange above, I think I was wrong earlier in this topic and I want to say so plainly rather than quietly editing.
The correction was fair and I had been repeating something I had not checked carefully enough.
Worth separating two things that post #27 runs together.
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.
post #39 is right about the mechanism and I think understates the practical bit.
Amino acid analysis gives content: it hydrolyses the peptide and quantifies the residues. It measures the peptide content independent of chromatographic purity. Very few supplier certificates report it.
Coming back to post #46, because the follow-up matters more than the original answer.
Water content (residual moisture) matters: lyophilised peptide is not dry. A few percent water is normal. The difference between a TFA salt and an acetate salt can be several percent. Content calculations need the water content to be accurate.
Sterility testing is separate: chromatographic purity, mass spectrometry, and endotoxin testing all say nothing about whether a solution is sterile. If sterility matters, it needs to be tested and reported.
Read the full topic (56 posts)
This topic was referenced in
- Reconciling a label claim with a content assayAnalytics › COA interpretation · 6 replies
- Counter-ion form: the field almost nobody reports — one year onAnalytics › COA interpretation · 139 replies
- Revisiting: A field-by-field walk through a certificate of analysisAnalytics › COA interpretation · 41 replies
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