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Analytics · COA interpretation · continued

Certificates issued by the seller versus by a laboratory posts 31–60

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

ZI
z.iyerTL25 Apr 2025#31

Reading back through, this was answered upthread and I missed it. My fault.

1 like 16mo
MS
m.stephanopoulosTL3Regular5 Apr 2025#32
i.boateng, post #29: 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

Building on post #30 rather than restating 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.

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

0 likes in reply to #29 16mo
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c.silvaTL26 Apr 2025 · edited#33

Amino acid analysis gives content: it hydrolyses the peptide and quantifies the residues. It measures the peptide content independent of chromatographic purity. Very few supplier certificates report it.

15 likes 16mo
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r.girardTL27 Apr 2025#34

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.

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p.marchettiTL27 Apr 2025#35

Where I part company with post #32, and it is a narrow parting.

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.

2 likes 16mo
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d.bakkerTL28 Apr 2025#36
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a.adebayoTL29 Apr 2025#37
cannula_trace, post #26: Post #24 and I disagree about the size of the effect, not about the direction. Reading old certificates: if a certificate is dated years ago, the lot it describes might be old. That is not automatically a problem but it is worth noting. Fresh testing on the current lot is stronger than old testing on an older lot. A single observation,… Go to post

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.

21 likes in reply to #26 16mo
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b.fonsecaTL210 Apr 2025#38

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 right answer here may simply be that it has not been measured.

9 likes 16mo
MP
mira.patelTL4 Admin10 Apr 2025#39

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 16mo
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a.novakTL211 Apr 2025#40

Reading old certificates: if a certificate is dated years ago, the lot it describes might be old. That is not automatically a problem but it is worth noting. Fresh testing on the current lot is stronger than old testing on an older lot.

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

22 likes 16mo
FP
forest_plotTL3Evidence synthesis12 Apr 2025#41

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.

It is a small point and it changes the answer, which is an awkward combination.

0 likes 16mo
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e.steinerTL212 Apr 2025#42
an.adeyemi, post #10: Answering the question post #7 raises rather than the one it answers. 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. It cost nothing to check and would have cost something not to. 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".

Somebody will have a better source than mine, and I hope they post it.

2 likes in reply to #10 16mo
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q.zhao_qaTL3Quality assurance13 Apr 2025#43

Post #40 is the version of this I will quote in future. One addition.

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.

8 likes 15mo
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i.lehtinenTL214 Apr 2025#44

Where I part company with post #42, and it is a narrow parting.

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".

Not disagreeing with anyone above, just adding the bit I keep having to look up.

19 likes 15mo
PI
p.iyer_pharmdTL3Pharmacist14 Apr 2025#45

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.

Adding a source would improve this post and I do not have one to hand.

0 likes 15mo
HI
h.iyerTL215 Apr 2025#46
s.balogun, post #15: Where I part company with post #14, and it is a narrow parting. 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

Certificates from a supplier's own laboratory are not independent by definition. That is not an accusation, it is a description, and it is why independent submission exists.

4 likes in reply to #15 15mo
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blank_injectionTL2Analytical chemist16 Apr 2025#47

Adding a data point of agreement rather than a data point.

12 likes 15mo
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n.villalobosTL216 Apr 2025#48

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.

That is a description of practice, not a recommendation of it.

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eire_readerTL217 Apr 2025#49
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z.szaboTL218 Apr 2025#50

Nothing to add, except that this is the answer I would give if asked.

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GSwinburneTL1Member18 Apr 2025#51

That reframing is the whole thing. The facts I already had.

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m.oyelaranTL219 Apr 2025#52

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".

The literature is thinner on this than the confidence in the thread implies.

17 likes 15mo
CI
citation_indexTL2Member20 Apr 2025#53
da.bakker, post #23: 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". This is the sort of thing that ought to be settled and apparently is not. 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.

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

7 likes in reply to #23 15mo
AK
a.kravchenkoTL220 Apr 2025#54

Post #53 is right about the mechanism and I think understates the practical bit.

Reading old certificates: if a certificate is dated years ago, the lot it describes might be old. That is not automatically a problem but it is worth noting. Fresh testing on the current lot is stronger than old testing on an older lot.

1 like 15mo
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BirkelandTL3Regular21 Apr 2025 · edited#55

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 treat that as a working assumption and revisit it.

0 likes 15mo
VR
v.rautioTL222 Apr 2025#56

Adding thanks rather than a view. I do not have a view worth the space.

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CT
cannula_traceTL3Regular22 Apr 2025#57
sharps_bin, post #30: 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

I had written a reply contradicting post #53 and deleted it. Here is what survived.

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".

11 likes in reply to #30 15mo
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g.amankwahTL223 Apr 2025#58

Confirming post #57 from a second method, which matters more than confirming it from a second person.

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.

3 likes 15mo
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OTeixeiraTL3Regular24 Apr 2025#59

Certificates from a supplier's own laboratory are not independent by definition. That is not an accusation, it is a description, and it is why independent submission exists.

If that is already documented somewhere, ignore me and link it.

18 likes 15mo
SO
s.oyelaranTL224 Apr 2025#60

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 am confident about the direction and much less about the magnitude.

7 likes 15mo