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ForumsCOA & Analytical TestingCOA database project — my results so far

COA database project — my results so far

SaraMom3 Sun, Apr 6, 2025 at 3:40 AM 10 replies 1,543 viewsPage 1 of 2
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SaraMom3
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Apr 6, 2025 at 3:40 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

One addition: an unstated method makes a report close to uninterpretable. "99% pure" without the technique, the standard and the conditions is a claim, not a measurement.

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

What would genuinely help is knowing whether a purity figure and a content figure can disagree without one of them being wrong. Not looking for reassurance. Looking for the part I have got wrong.

— SaraMom3 · corrections welcome and will be edited into this post with credit
42 12BethLabQueen, ChrisMacros, KetoKyle and 39 others
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Dr.AddMedPHL
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Apr 6, 2025 at 3:53 AM#2
SaraMom3 said:
Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself…

No disagreement with SaraMom3. One condition attached. 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.

41 11sarah_nash92, FitDadDave, RunnerRach and 38 others
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Dr.BariatricHTX
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Apr 6, 2025 at 4:06 AM#3
SaraMom3 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.

Last edited: Apr 6, 2025 at 10:06 AM
40 10Dr.EM_Chicago, pete_RVA, CarlaRPh_TPA and 37 others
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TrialNerd_Beth
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Apr 6, 2025 at 4:19 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.

39 9DoseLogDan, SleepFixSam, PurityPaulOR and 36 others
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amy_econ_NJ
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Apr 6, 2025 at 5:29 AM#5
Dr.AddMedPHL said:
They are not contradictory, they measure different things, and this is the single most common misreading of a certificate.

Adding a me-too, because a thread of one person's experience is not much use. I had assumed I was the exception until I read this.

38 8NurseLeah_Nash, gary_naperville, sean_dublin and 35 others
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