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ForumsCOA & Analytical TestingBatch-to-batch purity variation — acceptable ranges

Batch-to-batch purity variation — acceptable ranges

kate.chem Sat, Jun 6, 2026 at 4:15 AM 15 replies 505 viewsPage 1 of 3
kate.chem
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Jun 6, 2026 at 4:15 AM#1

Read the primary source rather than the write-up and the two do not agree, so here is what is actually in it.

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.

Where I think it is weakest: the completion rate deserves as much attention as the headline, because a large effect among those who finished is a different claim from a large effect among those enrolled.

What I am after is why two laboratories report different purity for the same batch, and which number to believe. I have searched first, so if this is covered somewhere point me at it and I will read it.

Note on sourcing:
Figures above are from the primary publication rather than the press summary. If a number here disagrees with one you have, post yours and we will work out which of us is reading a secondary source.
43 13steve_okc, dave_SLC, FDA_TrackerJim and 40 others
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LibrarianMeg
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Jun 6, 2026 at 4:20 AM#2
kate.chem said:
The provenance questions are more useful than the numbers.

Agreeing with kate.chem, and the qualification matters more than the agreement. 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.

Last edited: Jun 6, 2026 at 6:20 AM
42 12PharmD_Rodriguez, julia.endo, JessicaM_2024 and 39 others
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Dr.NutriCornell
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Jun 6, 2026 at 4:25 AM#3
kate.chem said:
The provenance questions are more useful than the numbers.

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.

41 11laura_annarbor, JenMemphis, pat_auckland and 38 others
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Dr.PulmRoch
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Jun 6, 2026 at 4:30 AM#4

This one has a reasonably settled answer, so here it is. 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 6, 2026 at 5:30 AM
40 10DebRD_ATL, KristenIndy, MarkLI_maint and 37 others
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adam_van
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Jun 6, 2026 at 4:57 AM#5
LibrarianMeg said:
Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself…

Second this.

39 9hyun_seoul, jim_asheville, matt_MKE and 36 others
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