On aggregates, I would rather understate and be corrected upward than overstate and be quoted. That is a house style here and it is a good one.
Aggregates and why a purity assay may miss them entirely
Residual solvents: traces of solvents used in purification. These are usually tested by gas chromatography, not by HPLC. A specification for residual solvents should be stated separately from the purity.
Coming back to post #12, because the follow-up matters more than the original answer.
The number people quote for aggregates is a central estimate presented without its interval, and the interval is wide enough that the estimate is nearly uninformative on its own.
What I would check first on aggregates is whether the thing being measured moved or whether the way of measuring it moved. Those look identical in a graph.
Adding the measurement that post #36 says would settle it.
That last point is the ceiling on what any purity figure can claim. A method that cannot see a species cannot exclude it, and no certificate says which species its method cannot see.
I changed my mind about aggregates after someone here asked me for the source and I could not produce one. That is worth saying out loud because it is the ordinary way it happens.
The arithmetic in post #57 is right; the assumption feeding it is the part to check.
Off-target structures: if the sequence synthesis goes wrong, a completely different amino acid can be incorporated. The resulting off-target peptide is a structural isomer with the same mass but a different sequence. No chromatographic purity method detects this without a reference standard.
Posted with less confidence than the sentence structure implies.
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- Residual solvents and scavengers: what is looked for — what changed sinceAnalytics › Impurities & related substances · 41 replies
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