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Analytics · COA interpretation

"Greater than or equal to 99%" as a specification rather than a result

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Solved by SHermansen in post #5
On the opening post — agreed on the reasoning, with one qualification. Asking for the batch record rather than the certificate is a reasonable request and the response to it is informative whichever way it goes. That is one dataset and I would not build a rule on it.

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MY
m.yilmazTL223 Jun 2025#1

"Greater than or equal to 99%" as a specification rather than a result Writing it up because I had to work it out twice and would rather nobody else did.

Setting out an integration problem with the actual figures, because describing it in words has not worked.

Main peak with a trailing shoulder. Valley-to-valley gives 97.8%. A tangent skim gives 99.1%. Both are defensible and they are more than a point apart.

The question I actually have is which convention I should be asking suppliers to report, rather than which one is right.

6 likes 13mo
JS
j.sandvikTL228 Jun 2025#2

An itemised related-substances table with retention times says considerably more about the synthesis than a single total. A total tells you how much is not the main peak and nothing about what it is.

I would be glad to be shown a cleaner way of putting this.

0 likes 13mo
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RodriguesTL3Regular2 Jul 2025#3

The distinction between release testing and characterisation is one industrial documents make and retail ones usually do not. It is the difference between "we tested every lot for this" and "we established this once".

Marking that as an opinion rather than a finding.

23 likes 13mo
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p.trevinoTL26 Jul 2025 · edited#4

The opening post is right about the mechanism and I think understates the practical bit.

A chromatogram supplied as a small image is legible for peak shape and not for baseline detail. That is enough to sanity-check an integration and not enough to reproduce it.

I would put the burden of proof on the interesting explanation, not the dull one.

10 likes 13mo
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SHermansenTL2Member Solution9 Jul 2025#5

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

Asking for the batch record rather than the certificate is a reasonable request and the response to it is informative whichever way it goes.

That is one dataset and I would not build a rule on it.

8 likes 13mo
AZ
an.zamoraTL212 Jul 2025#6
Rodrigues, post #3: The distinction between release testing and characterisation is one industrial documents make and retail ones usually do not. It is the difference between "we tested every lot for this" and "we established this once". Marking that as an opinion rather than a finding. Go to post

Reading rather than answering, but this is the post I would point somebody at.

0 likes in reply to #3 13mo
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methods_draftTL2Member14 Jul 2025#7

A chromatogram supplied as a small image is legible for peak shape and not for baseline detail. That is enough to sanity-check an integration and not enough to reproduce it.

16 likes 12mo
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k.ogunleyeTL217 Jul 2025#8

An itemised related-substances table with retention times says considerably more about the synthesis than a single total. A total tells you how much is not the main peak and nothing about what it is.

6 likes 12mo
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batchlogTL3Regular20 Jul 2025 · edited#9
p.trevino, post #4: The opening post is right about the mechanism and I think understates the practical bit. A chromatogram supplied as a small image is legible for peak shape and not for baseline detail. That is enough to sanity-check an integration and not enough to reproduce it. I would put the burden of proof on the interesting explanation, not the… Go to post

The distinction between release testing and characterisation is one industrial documents make and retail ones usually do not. It is the difference between "we tested every lot for this" and "we established this once".

0 likes in reply to #4 12mo
DF
d.ferreiraTL222 Jul 2025#10
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c.balogunTL225 Jul 2025#11
SHermansen, post #5: On the opening post — agreed on the reasoning, with one qualification. Asking for the batch record rather than the certificate is a reasonable request and the response to it is informative whichever way it goes. That is one dataset and I would not build a rule on it. Go to post

An itemised related-substances table with retention times says considerably more about the synthesis than a single total. A total tells you how much is not the main peak and nothing about what it is.

Stating my assumptions rather than smuggling them in.

2 likes in reply to #5 12mo
KF
k.farrugiaTL3Regular27 Jul 2025#12
k.ogunleye, post #8: An itemised related-substances table with retention times says considerably more about the synthesis than a single total. A total tells you how much is not the main peak and nothing about what it is. Go to post

Worth separating two things that post #8 runs together.

A chromatogram supplied as a small image is legible for peak shape and not for baseline detail. That is enough to sanity-check an integration and not enough to reproduce it.

8 likes in reply to #8 12mo
RO
r.oyelaranTL230 Jul 2025#13

The distinction between release testing and characterisation is one industrial documents make and retail ones usually do not. It is the difference between "we tested every lot for this" and "we established this once".

Worth reading the earlier posts in this thread before acting on mine.

26 likes 12mo
JH
j.habermannTL3Regular1 Aug 2025#14

An itemised related-substances table with retention times says considerably more about the synthesis than a single total. A total tells you how much is not the main peak and nothing about what it is.

The confident version of this sentence would be wrong, so here is the hedged one.

0 likes 12mo
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d.nwosuTL23 Aug 2025#15

A chromatogram supplied as a small image is legible for peak shape and not for baseline detail. That is enough to sanity-check an integration and not enough to reproduce it.

0 likes 12mo
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e.mikkelsenTL2Member6 Aug 2025 · edited#16
k.farrugia, post #12: Worth separating two things that post #8 runs together. A chromatogram supplied as a small image is legible for peak shape and not for baseline detail. That is enough to sanity-check an integration and not enough to reproduce it. Go to post

Post #12 and I disagree about the size of the effect, not about the direction.

An itemised related-substances table with retention times says considerably more about the synthesis than a single total. A total tells you how much is not the main peak and nothing about what it is.

4 likes in reply to #12 12mo
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a.petrovTL28 Aug 2025#17

Marking my place. If it changes for me I will come back and say so.

19 likes 12mo
SP
s.poulsenTL3Regular10 Aug 2025#18

A certificate of analysis is a statement by its issuer that a defined test was performed on a defined lot and produced a defined result. That is all it is, and it is not nothing. What makes it usable: lot identifier matching the container, test date, method identification specific enough to reproduce, the actual result as a number, and the acceptance criterion stated separately from the result.

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

0 likes 12mo
GB
g.bakkenTL212 Aug 2025 · edited#19

Adding the measurement that post #18 says would settle it.

The distinction between release testing and characterisation is one industrial documents make and retail ones usually do not. It is the difference between "we tested every lot for this" and "we established this once".

0 likes 12mo
ST
sterile_tableTL3Regular14 Aug 2025#20
batchlog, post #9: The distinction between release testing and characterisation is one industrial documents make and retail ones usually do not. It is the difference between "we tested every lot for this" and "we established this once". Go to post

Post #16 describes the usual case. This is about the unusual one.

When a document puts the specification in the result column, it has told you the release criterion, not the measurement. Those are different claims and the second is weaker.

It is the kind of thing that is obvious once and never again.

2 likes in reply to #9 11mo
BF
b.fonsecaTL217 Aug 2025#21

The distinction between release testing and characterisation is one industrial documents make and retail ones usually do not. It is the difference between "we tested every lot for this" and "we established this once".

I checked the source rather than the summary, and they differ.

31 likes 11mo
DT
d.tammTL219 Aug 2025#22

A chromatogram supplied as a small image is legible for peak shape and not for baseline detail. That is enough to sanity-check an integration and not enough to reproduce it.

15 likes 11mo
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a.novakTL221 Aug 2025#23
k.ogunleye, post #8: An itemised related-substances table with retention times says considerably more about the synthesis than a single total. A total tells you how much is not the main peak and nothing about what it is. Go to post

On post #21 — agreed on the reasoning, with one qualification.

The fields that make one usable: lot identifier matching the container, test date, method identification specific enough to reproduce, the result as a number, and the acceptance criterion stated separately from the result.

6 likes in reply to #8 11mo
AA
a.adebayoTL223 Aug 2025#24

Useful. I had the fact and not the reason, which turns out to be the important half.

1 like 11mo
EV
e.vargaTL225 Aug 2025#25

An itemised related-substances table with retention times says considerably more about the synthesis than a single total. A total tells you how much is not the main peak and nothing about what it is.

I have seen it go both ways, which is why I hedge.

23 likes 11mo
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mira.patelTL427 Aug 2025#26
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r.zielinskiTL229 Aug 2025#27
methods_draft, post #7: A chromatogram supplied as a small image is legible for peak shape and not for baseline detail. That is enough to sanity-check an integration and not enough to reproduce it. Go to post

What fields matter on a certificate: lot number matching the vial, test date, the analytical method stated specifically, the measured result as a number, and the acceptance limit stated separately. A certificate missing any of these is weaker.

3 likes in reply to #7 11mo
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r.aldana_pharmdTL4Pharmacist31 Aug 2025#28

Adding the measurement that post #25 says would settle it.

A chromatogram supplied as a small image is legible for peak shape and not for baseline detail. That is enough to sanity-check an integration and not enough to reproduce it.

0 likes 11mo
DV
d.vukovicTL22 Sep 2025#29

Everything in post #25 holds. The case it does not cover is the one I have.

An itemised related-substances table with retention times says considerably more about the synthesis than a single total. A total tells you how much is not the main peak and nothing about what it is.

One case, stated as one case.

0 likes 11mo
LG
lc_gradientTL3Analytical chemist4 Sep 2025#30

Narrowing post #29, because the general version has more than one answer.

A document that puts the specification in the result column has told you the release criterion rather than the measurement. Those are different claims and the difference is the whole point of reading the document.

I keep a log of this specifically because memory is unreliable about it.

30 likes 11mo