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ForumsCOA & Analytical TestingCOA database project — my results so far

COA database project — my results so far

nick_SD_fit Wed, Jun 26, 2024 at 6:08 AM 13 replies 2,095 viewsPage 1 of 3
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nick_SD_fit
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Jun 26, 2024 at 6:08 AM#1

This is the version of the explanation I wish somebody had given me, written down before I forget what confused me. It is about certificates of analysis, and it is deliberately narrow — everything I am not confident about is marked as such.

What is actually established

Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself calibrated, the gradient and column, the detection wavelength, and where the integration baseline was drawn. A percentage point or two between competent labs is expected. What is not expected is a large gap, and the usual explanation there is that one report is not of the batch in your hand.

The condition it depends on

Mass spec answers a question purity does not: identity. High purity tells you one thing dominates the chromatogram, not that it is the molecule you ordered. A mass within about a dalton of expected is the identity check.

The practical version

The four things to check on any report, in order: does it name your batch, who commissioned it, what method was used, and does it report content as well as purity. A report failing any of those is weak evidence regardless of the percentage on it.

What I am not sure about

The question I want answered is why two laboratories report different purity for the same batch, and which number to believe. Numbers rather than impressions, if you have them.

— nick_SD_fit · corrections welcome and will be edited into this post with credit
19 14SkepticalSean, Dr.CardioMD, EndoResFellow and 16 others
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Dr.ObesityLA
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Jun 26, 2024 at 6:15 AM#2
nick_SD_fit said:
Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself…

That is correct as far as it goes, and here is where it stops going. They are not contradictory, they measure different things, and this is the single most common misreading of a certificate. Purity is a relative area measurement: the main peak as a percentage of total peak area in the chromatogram. Content is an absolute mass measurement against a reference standard. A vial can be 99% pure and contain 6.1mg — pure material, overfilled — or 99% pure and contain 3mg, which is pure material and a short fill. Purity tells you what fraction of what is there is the right molecule; content tells you how much of it there is. You need both, and a certificate with only purity is telling you half the story.

Last edited: Jun 26, 2024 at 7:15 AM
18 13KarenAZ_mom, zoe_NC, Dr.ObesityLA and 15 others
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Dr.GastroMayo
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Jun 26, 2024 at 6:22 AM#3
nick_SD_fit said:
Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself…

I am more sceptical of certificates as a category than this thread is. The document tells you about a sample somebody chose to send, at a moment in time, and nothing about the vial in your hand. Independent purchase-and-test is a different quality of evidence and everything else is inference.

17 12COA_Karl, MikeFit_NJ, InsuranceTom and 14 others
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Dr.SportsMedIN
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Jun 26, 2024 at 6:29 AM#4

Short answer first, then the reasoning. The provenance questions are more useful than the numbers. Does the report name the batch on your vial. Is the date consistent with when that batch existed. Is it addressed to the vendor or to the person who paid for the test. Was the sample taken from general stock or supplied by the vendor. A perfect certificate for a different batch is worth nothing, and vendor-supplied samples are the most common way a genuine report ends up misleading.

Happy to go further on any of that.

16 11Dr.SurgeonPGH, rachel_ABQ, traveltech_sara and 13 others
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JessicaM_2024
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Jun 26, 2024 at 7:04 AM#5
Dr.ObesityLA said:
They are not contradictory, they measure different things, and this is the single most common misreading of a certificate.

Can confirm. Same sequence, different timescale. The detail I would add is minor and it is already implied above.

Last edited: Jun 26, 2024 at 8:04 AM
15 10kevin_tulsa, Dr.PainCLE, mike_mealprep and 12 others
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