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ForumsCOA & Analytical TestingCommunity-funded testing initiative — 6 month update

Community-funded testing initiative — 6 month update

mike_mod Tue, May 6, 2025 at 2:25 PM 15 replies 1,708 viewsPage 1 of 3
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mike_mod
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May 6, 2025 at 2:25 PM#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 bit I cannot resolve on my own is why two laboratories report different purity for the same batch, and which number to believe.

Tell me what I have not thought of.

35 5PharmHunterJen, TomTeleRx, DoseLogDan and 32 others
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mike.trainer_LA
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May 6, 2025 at 3:50 PM#2

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.

34 4newstart_MO, mia_MS2, LeilaHI and 31 others
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sarah_TO
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May 6, 2025 at 5:15 PM#3
mike.trainer_LA said:
Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself…

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.

33 3GraceAZ_72, carl_compliance, DanielChem_CHI and 30 others
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steve_okc
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May 6, 2025 at 6:40 PM#4
mike_mod 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. 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.

32 2CanadaChris, ZaraB_AL, JakeSmashed95 and 29 others
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Dr.PulmRoch
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May 7, 2025 at 2:54 AM#5

From the other side of the consultation, briefly.

I tested my certificates of analysis batch through Janoshik — 99.5% purity. That's within acceptable range for compounded peptides. Turnaround was 8 business days.

The test costs ~$125 but gives you actual HPLC chromatography data plus mass spec confirmation. For the peace of mind alone, it's worth every penny. I test every new batch from a new vendor.

31 1KristenIndy, MarkLI_maint, Dr.PeteFamMed and 28 others
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