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ForumsCOA & Analytical TestingEndotoxin testing methods — LAL vs recombinant Factor C

Endotoxin testing methods — LAL vs recombinant Factor C

LabKate Mon, Jun 8, 2026 at 4:54 AM 17 replies 356 viewsPage 1 of 4
LabKate
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Jun 8, 2026 at 4:54 AM#1

Posting this because the summary going around does not say what the paper says, and the difference matters for how people here are using it.

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.

Where I think it is weakest: the subgroup findings are the part I trust least — with enough subgroups something is always significant, and these were not all pre-registered.

The question I want answered is whether a purity figure and a content figure can disagree without one of them being wrong. 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.
41 11JenMemphis, pat_auckland, Dr.GastroMayo and 38 others
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Dr.ObesityLA
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Jun 8, 2026 at 5:01 AM#2
LabKate said:
They are not contradictory, they measure different things, and this is the single most common misreading of a certificate.

No disagreement with LabKate. One condition attached. 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.

40 10KarenAZ_mom, zoe_NC, Dr.ObesityLA and 37 others
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BethLabQueen
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Jun 8, 2026 at 5:08 AM#3
LabKate said:
They are not contradictory, they measure different things, and this is the single most common misreading of a certificate.

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.

Correct me if the detail matters more than I have assumed.

Last edited: Jun 8, 2026 at 6:08 AM
39 9lori_vegas, Dr.PulmRoch, maya_sedona and 36 others
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carl_compliance
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Jun 8, 2026 at 5:15 AM#4

Short answer first, then the reasoning. 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.

38 8FDA_TrackerJim, ricardo_MIA, BrianDallas92 and 35 others
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fiona_glasgow
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Jun 8, 2026 at 5:57 AM#5
Dr.ObesityLA said:
The provenance questions are more useful than the numbers.

This matches mine closely enough to be worth saying so out loud.

Last edited: Jun 8, 2026 at 10:57 AM
37 7NeuroNate, JessicaH_TX, KevinCompounds and 34 others
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