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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

Putting this up for argument rather than for agreement. I have read it twice and I am still not certain what it supports.

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 follow-up is short relative to how long people actually take these drugs, so durability is an assumption here rather than a finding.

The narrow version of the question is why two laboratories report different purity for the same batch, and which number to believe. I would rather have one careful answer than five confident ones.

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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labquiet_amy
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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.

That is the short version; the long version is somebody else's post.

42 12HPLC_Greg, LibrarianMeg, bri_stats and 39 others
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Dr.SleepRoch
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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.

Last edited: Jun 6, 2026 at 8:25 AM
41 11Dr.NephBHM_UK, kim_atl_prep, sarah_TO and 38 others
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james_edin
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Jun 6, 2026 at 4:30 AM#4

Answering the narrow version, because the broad one does not have a single answer. 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.

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tampaLisa73
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Jun 6, 2026 at 4:57 AM#5
labquiet_amy said:
Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself…

This is my experience too, for whatever a second data point is worth. Posting only so the count is not one.

39 9TomFromTexas, mike.trainer_LA, sarah_nash92 and 36 others
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