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Sourcing · Red flags · continued

Second pass at: Identical chromatograms across two different lots posts 31–60

This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.

DV
d.vestergaardTL227 Feb 2026#31
TL4_Halvorsen, post #22: The guidelines draw that line for a practical reason as much as a fair one: reports accumulate into something useful and allegations do not. Caveat: everything above assumes the paperwork is what it says it is. Go to post

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

I would put this at better than even and not much better.

3 likes in reply to #22 5mo
VT
vial_tableTL2Member27 Feb 2026 · edited#32
r.restrepo, post #16: The practical version of Identical chromatograms is three sentences long. The rigorous version is three pages and reaches the same conclusion with the conditions attached. Go to post

Inconsistency across documents: a certificate stating one purity, a website claiming another, and a supplier's verbal representation claiming a third, all on the same product, is a red flag for either incompetence or deception.

Old habit: I write down the expected answer before I calculate it.

0 likes in reply to #16 5mo
KB
ka.batistaTL228 Feb 2026#33

On Identical chromatograms the community has more anecdote than the confidence in this thread implies, and I include my own contribution in that.

23 likes 5mo
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FairweatherTL2Member28 Feb 2026#34

Adding the measurement that post #31 says would settle it.

Posting my Identical chromatograms numbers with the method attached so they can be discounted properly. Uncontrolled, unblinded, and collected by someone who wanted a particular answer.

10 likes 5mo
NC
n.chowdhuryTL21 Mar 2026#35

Noted, and I have changed what I was going to do on the strength of it.

6 likes 5mo
SF
sterile_fileTL3Regular1 Mar 2026 · edited#36
r.ekstrom, post #21: 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

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.

1 like in reply to #21 5mo
FP
f.petrovTL22 Mar 2026#37

On post #36 — agreed on the reasoning, with one qualification.

I would keep Identical chromatograms and the decision it usually gets used for separate in this thread. They are related and they are not the same question, and merging them is why the last one went badly.

30 likes 5mo
AS
a.stephanopoulosTL3Regular2 Mar 2026#38

Picking up post #36: that is the part I would want checked first.

Identical chromatograms is worth one more sentence than it usually gets, and the sentence is the one about how the number was arrived at.

15 likes 5mo
PF
p.friskTL23 Mar 2026#39

Post #36 put the caveat in the right place and I want to underline it.

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 5mo
VM
v.milanoviTL3Regular3 Mar 2026#40
a.westergaard, post #11: Careful with the language on Identical chromatograms. "Not detected" and "not present" are different findings and the first is a statement about the method. Go to post

Building on post #39 rather than restating it.

Trying to state the Identical chromatograms position in a way that someone who disagrees would recognise as fair, because I do not think the version in this thread passes that test.

32 likes in reply to #11 5mo
AA
a.almeidaTL24 Mar 2026#41
t.dumitru, post #23: The arithmetic in post #21 is right; the assumption feeding it is the part to check. Two things can be true about Identical chromatograms at once: the mechanism is plausible and the evidence for the size of the effect is thin. Most of the argument here is people defending the first against attacks on the second. Go to post

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.

8 likes in reply to #23 5mo
AW
a.weissTL24 Mar 2026#42

I have been on both sides of the Identical chromatograms argument in this category within eighteen months, which should tell you how strong the evidence for either side is.

19 likes 5mo
KR
k.roosTL25 Mar 2026#43

Confirming post #40 from a second method, which matters more than confirming it from a second person.

On Identical chromatograms, 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.

0 likes 5mo
KS
k.salinasTL25 Mar 2026 · edited#44
r.sobczak, post #10: Nothing here should be read as an accusation against a named company, and the guidelines exist so that reports remain reports. The rule of thumb is fine; the edge cases are where it earns its keep. Go to post

The guidelines draw that line for a practical reason as much as a fair one: reports accumulate into something useful and allegations do not.

Correct me on the arithmetic if it is wrong; I would rather know.

0 likes in reply to #10 5mo
IB
i.brobergTL25 Mar 2026#45

Adding a small correction to the Identical chromatograms summary above rather than a disagreement with it. The substance holds; one of the figures is out by a factor that matters.

12 likes 5mo
HM
h.mukherjeeTL1Member6 Mar 2026#46

Worth separating two things that post #42 runs together.

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 claim is narrower than it sounds, and deliberately so.

26 likes 5mo
MM
m.malinowskiTL26 Mar 2026#47

Identical chromatograms is a good example of a question where the honest answer is boring and the interesting answers are unsupported. I would go with boring.

0 likes 5mo
PS
p.silvaTL27 Mar 2026#48
r.restrepo, post #16: The practical version of Identical chromatograms is three sentences long. The rigorous version is three pages and reaches the same conclusion with the conditions attached. Go to post

Second this, and I would have said it less carefully.

2 likes in reply to #16 5mo
SK
s.karlsen_rphTL3Pharmacist7 Mar 2026#49
m.lindqvist, post #17: Post #13 and I disagree about the size of the effect, not about the direction. Where I would push back on the Identical chromatograms consensus is the confidence, not the direction. The direction looks right. The confidence is borrowed. Go to post

The arithmetic in post #47 is right; the assumption feeding it is the part to check.

Identical chromatograms sits at the boundary between what this community can usefully discuss and what it cannot, and I think it falls on the discussable side, narrowly.

2 likes in reply to #17 5mo
OV
o.vukovicTL28 Mar 2026#50
j.nascimento, post #29: This follows post #26 rather than contradicting it. 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

Answering the question post #46 raises rather than the one it answers.

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.

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

8 likes in reply to #29 5mo
FN
formulary_notesTL3Regular8 Mar 2026#51
a.stephanopoulos, post #38: Picking up post #36: that is the part I would want checked first. Identical chromatograms is worth one more sentence than it usually gets, and the sentence is the one about how the number was arrived at. Go to post

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.

4 likes in reply to #38 5mo
RB
r.bruunTL29 Mar 2026#52
TH
TL4_HalvorsenTL4Leader · Journal club9 Mar 2026#53

I read the earlier replies on Identical chromatograms twice before writing this, because I had assumed the opposite and wanted to be sure I was disagreeing with what was said rather than what I expected.

0 likes 5mo
CC
ch.correiaTL29 Mar 2026#54

The honest answer on Identical chromatograms is that it depends, and the useful part is the list of what it depends on. Four items, in rough order of how much they matter.

Most people get the first two right and then argue about the fourth.

17 likes 5mo
DV
dr.villanuevaTL3Physician10 Mar 2026#55
m.malinowski, post #47: Identical chromatograms is a good example of a question where the honest answer is boring and the interesting answers are unsupported. I would go with boring. Go to post

This is the first time the answer has come with its own limits attached. Appreciated.

7 likes in reply to #47 5mo
YA
y.adebayoTL210 Mar 2026#56

This follows post #53 rather than contradicting it.

The guidelines draw that line for a practical reason as much as a fair one: reports accumulate into something useful and allegations do not.

Scoping that to what I have actually seen rather than what I have read.

1 like 5mo
MH
ms_hollowayTL4Mass spectrometrist11 Mar 2026#57

On Identical chromatograms I would separate what is worth knowing from what is worth acting on. The first list is long and the second is short, and conflating them is how threads get heated.

0 likes 5mo
NS
n.silvaTL211 Mar 2026#58
a.westergaard, post #11: Careful with the language on Identical chromatograms. "Not detected" and "not present" are different findings and the first is a statement about the method. Go to post

Counterpoint on Identical chromatograms, offered without confidence: the same observation is consistent with a much duller explanation, and nobody has ruled the dull one out.

24 likes in reply to #11 5mo
ST
sterile_tableTL3Regular12 Mar 2026 · edited#59

On post #57 — agreed on the reasoning, with one qualification.

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

The short answer was in the first line; everything after is the working.

0 likes 5mo
SR
sa.rasmussenTL212 Mar 2026#60
baseline_table, post #19: Everything in post #17 holds. The case it does not cover is the one I have. One caution on Identical chromatograms: everything above assumes the underlying documentation is what it claims to be. That assumption is doing real work and is rarely stated. Go to post

The arithmetic on Identical chromatograms is the easy part and it is where the errors are, which is an uncomfortable combination. Show your working and someone will catch it.

0 likes in reply to #19 5mo