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Evidence-based GLP-1 & peptide discussion since 2023
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

This gets cited here weekly, usually second-hand, so it is worth setting out what it does and does not establish.

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.

Where I think it is weakest: the population was selected and supported in ways a real cohort is not, so I would read the effect size as a ceiling rather than an expectation.

So the question, as narrowly as I can put it: why two laboratories report different purity for the same batch, and which number to believe. Practical detail welcome, however dull — the duller the better.

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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sarah.morrison
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Jun 8, 2026 at 5:01 AM#2
LabKate said:
Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself…

Agreeing with LabKate, and the qualification matters more than the agreement. 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.

40 10roxy_nash, tony_orlando, Dr.NephBHM_UK and 37 others
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InsuranceTom
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Jun 8, 2026 at 5:08 AM#3
LabKate 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: Jun 8, 2026 at 10:08 AM
39 9Dr.ReproEndo, lucas_SP_BR, lisa_labSD and 36 others
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sarah_TO
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Jun 8, 2026 at 5:15 AM#4

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

Last edited: Jun 8, 2026 at 9:15 AM
38 8carl_compliance, DanielChem_CHI, marco_milano and 35 others
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tyler_CSCS
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Jun 8, 2026 at 5:57 AM#5
sarah.morrison said:
They are not contradictory, they measure different things, and this is the single most common misreading of a certificate.

Second this.

37 7bbq_ray_KC, oliver_london, tane_welly and 34 others
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