Purity and content are different measurements: purity tells you what proportion of the detected material is the intended species. Content tells you how much of the intended species is present in the container. A lyophilised vial can be 99% pure and contain considerably less than the label claims because the remainder is water, counter-ion and excipient.
Coming back to: Batch date after test date, and other internal inconsistencies
Worth separating two things that post #4 runs together.
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.
On post #7 — agreed on the reasoning, with one qualification.
Reading old certificates: if a certificate is dated years ago, the lot it describes might be old. That is not automatically a problem but it is worth noting. Fresh testing on the current lot is stronger than old testing on an older lot.
post #15 is right about the mechanism and I think understates the practical bit.
Endotoxin testing is separate: a certificate of purity says nothing about endotoxin. A chemically pure preparation can carry a clinically significant endotoxin load. If endotoxin matters, it needs to be tested and reported.
Two things before anyone answers the substance.
First, the context in the first post is clear and specific. Second, the question is framed so that an answer can actually address it. Both are the norm here and both matter more than they sound.
Read the full topic (28 posts)
This topic was referenced in
- Water content on a certificate and why it changes the arithmeticAnalytics › COA interpretation · 23 replies
- Second pass at: Certificates issued by the seller versus by a laboratoryAnalytics › COA interpretation · 92 replies
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