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ForumsCOA & Analytical TestingParticulate matter testing — 6 month update

Particulate matter testing — 6 month update

BrianDallas92 Sat, Sep 27, 2025 at 1:53 AM 10 replies 1,196 viewsPage 1 of 2
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BrianDallas92
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Sep 27, 2025 at 1:53 AM#1

I have a certificate reporting 99.2% purity and 6.1mg content on a vial sold as 5mg, and I cannot work out whether those two numbers are consistent or contradictory.

The question I want answered is whether a purity figure and a content figure can disagree without one of them being wrong.

Not looking for reassurance. Looking for the part I have got wrong.

44 14Dr.PathRoch, mona_PHX, andrew_nyc and 41 others
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Dr.NateNeph
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Sep 27, 2025 at 2:04 AM#2

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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MeganSA_TX
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Sep 27, 2025 at 2:15 AM#3
Dr.NateNeph said:
They are not contradictory, they measure different things, and this is the single most common misreading of a certificate.

Agreed, and mass spec answers a question purity does not: identity. High purity tells you one thing dominates the chromatogram, not that it is the molecule you ordered. A mass within about a dalton of expected is the identity check.

42 12JessicaM_2024, TomFromTexas, mike.trainer_LA and 39 others
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Janoshik Analytical — Independent Testing

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roxy_nash
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Sep 27, 2025 at 2:26 AM#4
BrianDallas92 said:
I have a certificate reporting 99.2% purity and 6.1mg content on a vial sold as 5mg, and I cannot work out whether those two numbers are consistent or…

Same position here, arrived at the long way round. 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: Sep 27, 2025 at 8:26 AM
41 11Dr.NephBHM_UK, kim_atl_prep, sarah_TO and 38 others
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Dr.EM_Chicago
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Sep 27, 2025 at 3:23 AM#5

Clinical perspective, offered as context rather than as advice.

Mass spectrometry confirmation for certificates of analysis: beyond HPLC purity, mass spec tells you the molecule's exact molecular weight. This confirms identity — not just purity.

Why this matters: HPLC can show you a "pure" compound, but if it's pure of the WRONG compound, purity is meaningless. Mass spec at m/z 4113.58 Da confirms it's actually semaglutide. My Janoshik report includes both HPLC and mass spec.

If your testing provider only offers HPLC, consider upgrading to include mass spec for at least your first batch from a new vendor.

Last edited: Sep 27, 2025 at 7:23 AM
40 10lisa_labSD, adam_van, Dr.SurgeonPGH and 37 others
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