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Sourcing · Red flags

Identical chromatograms across two different lots

MA
m.adeyemiTL220 Jun 2024#1

Identical chromatograms across two different lots Writing it up because I had to work it out twice and would rather nobody else did.

Collecting what is known about identical chromatograms in one place, because it is currently spread across a category, two tag pages and a thread that is hard to find.

This is a summary rather than new work, and I have attributed each part to where I found it.

43 likes 2.1y
CT
cannula_traceTL3Regular28 Jun 2024#2

The opening post answers the question as asked. The question underneath it is different.

For anyone finding this later: the short answer on identical chromatograms is that it depends on one thing, and the rest of the thread is people identifying which thing.

10 likes 2.1y
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p.fontaineTL23 Jul 2024#3

Before the thread moves on from identical chromatograms — what is the sample size behind the claim? I am not being difficult; I have seen the same figure quoted from an n of four and from an n of four hundred.

1 like 2.1y
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BirkelandTL3Regular7 Jul 2024 · edited#4

Where somebody posts a concern, ask what would resolve it before arguing about it. Half of these threads end with a document nobody had asked for.

0 likes 2.1y
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se.okaforTL211 Jul 2024#5
cannula_trace, post #2: The opening post answers the question as asked. The question underneath it is different. For anyone finding this later: the short answer on identical chromatograms is that it depends on one thing, and the rest of the thread is people identifying which thing. Go to post

Clear enough that I do not think I have a follow-up, which is unusual.

31 likes in reply to #2 2y
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sharps_binTL2Regular15 Jul 2024#6
m.adeyemi, post #1: Identical chromatograms across two different lots Writing it up because I had to work it out twice and would rather nobody else did. Collecting what is known about identical chromatograms in one place, because it is currently spread across a category, two tag pages and a thread that is hard to find. This is a summary rather than new… Go to post

Narrowing post #4, because the general version has more than one answer.

Source for the identical chromatograms figure, since it was asked for. It is in the discussion rather than the abstract, which is why the version circulating is stronger than the paper is.

Reading the surrounding paragraph is worth the two minutes. The authors are more careful than their summarisers.

16 likes in reply to #1 2y
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g.amankwahTL219 Jul 2024#7

Identical chromatograms is one of those subjects where the general answer and the answer for a specific case diverge, and the thread will go in circles until someone says which one is being asked for.

3 likes 2y
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outline_firstTL3Wiki editor23 Jul 2024#8

Inability to trace lots: if you ask "where was this synthesised, by whom, under what conditions" and cannot get a clear answer, that is a red flag. Traceability is not glamorous but it is foundational.

Adding this to the thread rather than to the wiki, because I am not confident enough for the wiki.

0 likes 2y
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s.vogelTL227 Jul 2024#9

The useful distinction on identical chromatograms is between what was measured and what was inferred from it. Both end up in the same sentence and only one of them has error bars.

11 likes 2y
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KStephanopoulosTL330 Jul 2024#10
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c.kuuselaTL22 Aug 2024#11
outline_first, post #8: Inability to trace lots: if you ask "where was this synthesised, by whom, under what conditions" and cannot get a clear answer, that is a red flag. Traceability is not glamorous but it is foundational. Adding this to the thread rather than to the wiki, because I am not confident enough for the wiki. Go to post

Post #9 is right about the mechanism and I think understates the practical bit.

The strongest single signal available cheaply is what happens when you ask a technical question. A quantitative answer inside a working day is difficult to fake at scale.

The answer changed when I changed how I was measuring, which was informative.

21 likes in reply to #8 2y
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r.torrenceTL2Member6 Aug 2024#12

Coming back to post #8, because the follow-up matters more than the original answer.

I would put moderate confidence on the mainstream reading of identical chromatograms and no more. That is not scepticism for its own sake; it is where the sourcing actually stops.

0 likes 2y
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z.nakamuraTL29 Aug 2024#13

On identical chromatograms: the maintained page in the documentation commons covers the general case with citations and a review date, which is more reliable than any reply here including this one.

2 likes 2y
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IbrahimoviTL2Member12 Aug 2024 · edited#14

Keep the two claims separate. "The result on this lot did not match the certificate" is a report that can be checked. "This supplier is dishonest" is an allegation about intent and nothing in a chromatogram supports it.

The mechanism is plausible, which is not the same as established.

9 likes 2y
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e.kuipersTL215 Aug 2024#15

The confident answers on identical chromatograms and the well-sourced answers are not the same answers, which is the most useful thing I have learned reading this category.

29 likes 23mo
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lyophil_marginTL3Regular19 Aug 2024#16

I had written a reply contradicting post #12 and deleted it. Here is what survived.

The most useful contribution to this subcategory is a resolved case written up with the resolution, because the unresolved ones are all anyone remembers.

A single observation, in a thread that deserves better than single observations.

0 likes 23mo
MY
m.yildizTL222 Aug 2024#17

Worth separating identical chromatograms as a question about the compound from identical chromatograms as a question about the documentation. They get answered by different people and only one of them is answerable here.

5 likes 23mo
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taper_fileTL3Regular25 Aug 2024#18
sharps_bin, post #6: Narrowing post #4, because the general version has more than one answer. Source for the identical chromatograms figure, since it was asked for. It is in the discussion rather than the abstract, which is why the version circulating is stronger than the paper is. Reading the surrounding paragraph is worth the two minutes. The authors are… Go to post

Small correction to my own earlier position on identical chromatograms. I had the units the wrong way round, which changes the conclusion by an order of magnitude and therefore changes it entirely.

14 likes in reply to #6 23mo
SL
s.lindqvistTL228 Aug 2024#19
taper_file, post #18: Small correction to my own earlier position on identical chromatograms. I had the units the wrong way round, which changes the conclusion by an order of magnitude and therefore changes it entirely. Go to post

Where the same certificate image appears with different lot numbers, that is a documentation finding worth reporting with the images attached.

That is what the documentation says. What happens in practice is usually close.

0 likes in reply to #18 23mo
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figure_reviewTL2Member30 Aug 2024#20
Birkeland, post #4: Where somebody posts a concern, ask what would resolve it before arguing about it. Half of these threads end with a document nobody had asked for. Go to post

The reason identical chromatograms keeps being re-asked is that the answer is conditional and people quote it without the condition. It is not that the answer is unknown.

0 likes in reply to #4 23mo
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r.laurentTL22 Sep 2024#21
r.torrence, post #12: Coming back to post #8, because the follow-up matters more than the original answer. I would put moderate confidence on the mainstream reading of identical chromatograms and no more. That is not scepticism for its own sake; it is where the sourcing actually stops. Go to post

Post #17 describes the usual case. This is about the unusual one.

I would call the community position on identical chromatograms likely rather than established, and I would be comfortable defending that hedge.

28 likes in reply to #12 23mo
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e.verhoevenTL25 Sep 2024#22
outline_first, post #8: Inability to trace lots: if you ask "where was this synthesised, by whom, under what conditions" and cannot get a clear answer, that is a red flag. Traceability is not glamorous but it is foundational. Adding this to the thread rather than to the wiki, because I am not confident enough for the wiki. Go to post

Nothing here should be read as an accusation against a named company, and the guidelines exist so that reports remain reports.

14 likes in reply to #8 23mo
CB
c.boatengTL28 Sep 2024#23

Summarising the identical chromatograms thread so far, since it is long and the answer is buried: the first reply has the method, the fourth has the correction to it, and the rest is people agreeing at length.

5 likes 23mo
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mira.patelTL4 Admin11 Sep 2024#24

Prices well below the rest of the market are a fact rather than a finding. They are worth noting and they do not establish anything on their own.

0 likes 23mo
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d.bakkerTL214 Sep 2024#25

Genuine question rather than a rhetorical one: has anyone here actually observed identical chromatograms, as opposed to read about it? The thread is long and I cannot tell.

0 likes 22mo
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a.asanteTL216 Sep 2024#26
r.torrence, post #12: Coming back to post #8, because the follow-up matters more than the original answer. I would put moderate confidence on the mainstream reading of identical chromatograms and no more. That is not scepticism for its own sake; it is where the sourcing actually stops. Go to post

Practical answer on identical chromatograms, since the theoretical one is upthread: do the simplest check first, write down the result, and only then decide whether the complicated explanation is needed. It usually is not.

20 likes in reply to #12 22mo
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l.solbergTL219 Sep 2024#27

Reporting something here requires the batch, the date, the method and the document, which is exactly what makes the reports worth reading two years later.

I have written this out at length because the short version keeps being misread.

9 likes 22mo
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p.marchettiTL222 Sep 2024#28
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r.mensaTL225 Sep 2024#29

A document with no method identification is not evidence of anything wrong. It is evidence that the document cannot be checked, which is a different and weaker statement.

15 likes 22mo
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np_gilmoreTL3Nurse practitioner27 Sep 2024#30
Birkeland, post #4: Where somebody posts a concern, ask what would resolve it before arguing about it. Half of these threads end with a document nobody had asked for. Go to post

A stock listing that never changes and a lead time that never varies are both worth noticing. Real operations have variation in them.

If this contradicts something upthread, the upthread version may well be the better one.

5 likes in reply to #4 22mo