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Analytics · COA interpretation

Certificates issued by the seller versus by a laboratory

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g.amankwahTL27 Mar 2025#1

Posting this under the heading it deserves: Certificates issued by the seller versus by a laboratory Everything below is what sits behind that.

I would like to understand what this number means before I repeat it anywhere.

A Medutest report on a tirzepatide lot gives 96.5% purity. The supplier certificate for the same lot states 98.9%. Both documents name a reversed-phase method; neither states the same gradient.

My question is not "who is right". It is: given that those two figures were produced by different methods, what is the largest difference I should expect from method alone, and at what point does a gap stop being explainable that way?

37 likes 17mo
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chromatogramTL4Analytical chemist9 Mar 2025#2

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.

For what it is worth, the same held on the two occasions I checked.

0 likes 17mo
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t.dumitruTL211 Mar 2025#3
chromatogram, post #2: 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. For what it is worth, the same held on the two occasions I checked. 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.

If the premise is wrong, everything after it is decoration.

2 likes in reply to #2 17mo
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endo_fellow_rkTL3Endocrinology fellow12 Mar 2025#4
g.amankwah, post #1: Posting this under the heading it deserves: Certificates issued by the seller versus by a laboratory Everything below is what sits behind that. I would like to understand what this number means before I repeat it anywhere. A Medutest report on a tirzepatide lot gives 96.5% purity. The supplier certificate for the same lot states 98.9%.… Go to post

I had written a reply contradicting post #2 and deleted it. Here is what survived.

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 claim is narrower than it sounds, and deliberately so.

8 likes in reply to #1 17mo
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j.vogelTL213 Mar 2025#5

This follows post #4 rather than contradicting 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.

14 likes 17mo
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TL4_HalvorsenTL4Leader · Journal club14 Mar 2025 · edited#6

Thank you — that answers what I came here to find out.

28 likes 16mo
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h.lindqvistTL215 Mar 2025#7
j.vogel, post #5: This follows post #4 rather than contradicting 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. 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 #5 16mo
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appeals_deskTL3Regular16 Mar 2025#8

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.

None of the above is medical advice and I am not qualified to give any.

5 likes 16mo
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e.silvaTL217 Mar 2025#9
chromatogram, post #2: 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. For what it is worth, the same held on the two occasions I checked. Go to post

The arithmetic in post #8 is right; the assumption feeding it is the part to check.

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.

Two sources, same conclusion, and I could not rule out that one copied the other.

9 likes in reply to #2 16mo
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an.adeyemiTL218 Mar 2025#10
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z.okonkwoTL219 Mar 2025#11

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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p.iyer_pharmdTL3Pharmacist20 Mar 2025 · edited#12

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.

A weak preference rather than a position.

19 likes 16mo
JA
j.asanteTL221 Mar 2025#13
TL4_Halvorsen, post #6: Thank you — that answers what I came here to find out. Go to post

Helpful, and easy to find again, which is half of what a good reply is.

8 likes in reply to #6 16mo
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hana.satoTL4 Moderator22 Mar 2025#14

The arithmetic in post #12 is right; the assumption feeding it is the part to check.

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
SB
s.balogunTL223 Mar 2025#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.

27 likes 16mo
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k.otieno_statsTL3Statistician24 Mar 2025#16

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".

13 likes 16mo
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n.ibarraTL225 Mar 2025#17
TL4_Halvorsen, post #6: Thank you — that answers what I came here to find out. 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.

This is the version I would want a new member to read first.

4 likes in reply to #6 16mo
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system_suitabilityTL3Analytical chemist25 Mar 2025#18
t.dumitru, post #3: 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. If the premise is wrong, everything after it is decoration. Go to post

Adding the measurement that post #17 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.

I am aware this is the third time this month I have made this point.

0 likes in reply to #3 16mo
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h.karlsenTL226 Mar 2025#19
chromatogram, post #2: 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. For what it is worth, the same held on the two occasions I checked. 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.

One more caveat and then I will stop qualifying: the sample selected itself.

0 likes in reply to #2 16mo
LT
l.trevinoTL227 Mar 2025#20

Confirming post #17 from a second method, which matters more than confirming it from a second person.

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".

Take it as a starting point and not as a specification.

0 likes 16mo
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p.fontaineTL228 Mar 2025#21

This follows post #18 rather than contradicting it.

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.

Reading it back, the second half matters more than the first.

0 likes 16mo
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n.rowntreeTL3Regular29 Mar 2025#22

Worth separating two things that post #20 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.

I would want to see it done twice before believing it once.

1 like 16mo
DB
da.bakkerTL229 Mar 2025#23
p.iyer_pharmd, post #12: 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. A weak preference rather than a position. 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".

This is the sort of thing that ought to be settled and apparently is not.

10 likes in reply to #12 16mo
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c.wijnbergTL2Member30 Mar 2025#24
n.ibarra, post #17: 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. This is the version I would want a new member to read first. 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.

23 likes in reply to #17 16mo
JR
j.restrepoTL231 Mar 2025#25

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".

32 likes 16mo
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cannula_traceTL3Regular1 Apr 2025 · edited#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, in a thread that deserves better than single observations.

0 likes 16mo
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se.okaforTL22 Apr 2025#27
z.okonkwo, post #11: 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

Narrowing post #26, because the general version has more than one answer.

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.

That is the practical version. The rigorous version is longer and says the same thing.

6 likes in reply to #11 16mo
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outline_firstTL32 Apr 2025#28
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i.boatengTL23 Apr 2025#29
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sharps_binTL2Regular4 Apr 2025#30
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

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 #29 16mo