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ForumsCOA & Analytical TestingParticulate matter testing — USP <788> for injectable peptides

Particulate matter testing — USP <788> for injectable peptides

CarlaRPh_TPA Sat, May 23, 2026 at 9:37 AM 20 replies 606 viewsPage 1 of 4
CarlaRPh_TPA
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May 23, 2026 at 9:37 AM#1

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

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 comparator does most of the work in how this gets reported, and it is not the comparator most people think they are citing.

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 11FDA_TrackerJim, ricardo_MIA, BrianDallas92 and 38 others
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TrialTracker_MD
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May 23, 2026 at 9:50 AM#2
CarlaRPh_TPA said:
They are not contradictory, they measure different things, and this is the single most common misreading of a certificate.

That is correct as far as it goes, and here is where it stops going. 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 10stefan_berlin, Dr.EM_Chicago, pete_RVA and 37 others
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anders_CPH
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May 23, 2026 at 10:03 AM#3
CarlaRPh_TPA 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.

39 9AussieAnna, BethLabQueen, ChrisMacros and 36 others
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Dr.AddMedPHL
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May 23, 2026 at 10:16 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 8TomFromTexas, mike.trainer_LA, sarah_nash92 and 35 others
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robert_kc
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May 23, 2026 at 11:25 AM#5
TrialTracker_MD said:
The provenance questions are more useful than the numbers.

Adding a me-too, because a thread of one person's experience is not much use. Posting only so the count is not one.

37 7PharmHunterJen, TomTeleRx, DoseLogDan and 34 others
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