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c/coa·posted 2 years ago by u/santiago_szabo

[Discussion] the related substances advice in here is 3 years out of date

Discussion Sourced ×8 Cold Box ×1 Long Haul ×1

the related substances advice in here is 3 years out of date. It is the sort of thing everyone half-believes and nobody writes down.

3 years — those are the numbers, and they are the ones I am willing to defend.

Related substances itemised individually is a much stronger document than a single total, because it tells you the shape of the impurity profile rather than its size.

UV at 214nm sees the peptide bond and picks up almost everything; at 280nm you are looking at aromatics only. Which wavelength the number came from is part of the number.

Sceptical readings welcome. The confident ones are the ones I distrust.

7,744 up / 327 down96% upvoted57 commentsid 1yvo9r31 Jan 2024

57 comments

30 in this archive, depth 6

best — the order this archive was captured in

u/amylin_amyamylin889 points·2 years ago

The PDF creation date being later than the analysis date is usually a re-issue or a re-export. It is worth one question and it is not evidence of anything on its own.

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[deleted]656 points·2 years ago

[deleted]

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u/ismael_eriksen169 points·2 years ago

Are the related substances itemised or is it a single total?

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u/zaid_balogun69 points·2 years ago

Net peptide content is the fraction of the powder that is actually peptide once counterion, water and residual solvent are accounted for. A 99% pure acetate salt can still be about 85% peptide by mass.

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u/santiago_szaboOP0 points·2 years ago

Area percent or net peptide content? They answer different questions.

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u/santiago_szaboOP0 points·2 years ago

Batch number and date of analysis, are both on there?

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u/santiago_szaboOP0 points·2 years ago

What does the method line actually say? Not the technique — the column and the gradient.

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u/teodor_jansen115 points·2 years ago

Disagree that a lower number is automatically worse. A conservative claim that survives testing is worth more than an optimistic one that does not.

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u/milos_vanhecke662 points·2 years ago

net peptide content and purity are two different numbers on the same vial

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u/amira_dumitru414 points·2 years ago

LC-MS gives you identity; UV purity gives you a relative quantity. A document with the first and not the second, or the reverse, is answering half the question.

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u/anya_moreau473 points·2 years ago

Yes — and the reason to ask for the whole page is that the interesting parts are the ones people crop out to fit a screenshot.

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u/rania_okonkwo225 points·2 years ago

the lot on the vial has to match the lot on the page

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u/zaid_balogun73 points·2 years ago

chromatogram or it did not happen

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u/cormac_pereira622 points·2 years ago

The document I was worried about turned out to be a re-issue with a later creation date. Asked, got the original, entirely ordinary.

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u/karma_irrelevant372 points·2 years ago

Does the lot on the vial match the lot on the page?

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u/certified_referenceQC141 points·2 years ago

post the whole document, not the headline number

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u/amira_dumitru118 points·2 years ago

Asked QSC for the batch-specific certificate and had the full document — batch, date, method line naming the column — inside six hours. That is now my baseline for everybody.

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u/janek_ferrari132 points·2 years ago

Does the lot on the vial match the lot on the page?

Disagree on this specific point. Two honest labs can resolve that impurity differently and report different numbers.

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u/freya_baptista84 points·2 years ago

Not quite. Two labs with different gradients can resolve a close-eluting impurity differently and both be reporting honestly.

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u/coa_janitormod · c/coa0 points·2 years ago

Agreed on asking for the storage condition. It is one line and it changes how you read the entire stability claim.

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u/coa_collectorarchivist157 points·2 years ago

Yes. The structure of the document matters at least as much as the number printed on it.

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u/ignacio_silva282 points·2 years ago

a total of 0.4% tells you less than four named impurities adding to 0.6%

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u/purity_pedantMOD183 points·2 years ago

Left up and flaired Explainer. This is the answer we keep linking, written properly.

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u/aleksi_eriksen79 points·2 years ago

Same view. HJ prints the column and the gradient, which means somebody could actually reproduce the run.

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u/nabila_espinoza110 points·2 years ago·edited

I would not read a rounded figure as evasive. Plenty of documents round to one decimal as house style.

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u/wrong_network_w71 points·2 years ago

That is the catalogue certificate rather than the batch-specific one. Same layout, completely different status.

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u/soren_nkemelu63 points·2 years ago

This. Area percent answers "what fraction of what the detector saw was the peak I wanted", and people read it as "how much peptide is in the vial".

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u/santiago_szabo35 points·2 years ago

water content is on there and everyone skips it

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u/soren_zamora20 points·2 years ago

ask for the storage condition the stability statement was written against

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u/joaquin_ivaturi14 points·2 years ago

the related substances line is where the story is

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How to read a certificate of analysis and what it does and does not tell you. Area% versus mass%, identity versus quantity, water content, related substances, acetate counterions, and the difference between a vendor-supplied COA and an independent test on the vial you actually received.

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