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Evidence-based GLP-1 & peptide discussion since 2023
ForumsCOA & Analytical TestingHow to commission independent testing — need advice Page 2

How to commission independent testing — need advice

wendy_avl Thu, May 2, 2024 at 11:19 PM 18 replies 2,066 viewsPage 2 of 4
Dr.GastroMayo
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May 3, 2024 at 1:03 AM#6
pete_manc_UK said:
The provenance questions are more useful than the numbers.

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.

Ask again with the specifics and you will get a better answer than this one.

Last edited: May 3, 2024 at 6:03 AM
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HPLC_Greg
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May 3, 2024 at 1:43 AM#7
wendy_avl said:
Two reports on the same product from two laboratories, four percentage points apart, and no method stated on either.

HPLC results interpretation for certificates of analysis: when you get your Janoshik report back, here's what the numbers mean:

  • Purity %: Should be >97%. Below 95% is concerning.
  • Retention time: Should match reference standard for the peptide
  • Related substances: Degradation products should be <2% total
  • Single impurity: No individual impurity should exceed 1%

My last batch: 99.7% purity, 0.1% total related substances. Clean chromatogram with single sharp peak at expected retention time. Exactly what you want to see.

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Dr.EM_Chicago
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Chicago, IL
May 3, 2024 at 2:23 AM#8
Dr.GastroMayo said:
I am more sceptical of certificates as a category than this thread is.

COA red flags for certificates of analysis — here's what to look for when reviewing a Certificate of Analysis:

  • No HPLC data: If there's no chromatography graph, it's not a real COA
  • Exact 100% purity: Suspicious — real testing always shows slight variation
  • No batch number: Can't trace back to specific production
  • No endotoxin testing: For injectables, this is essential
  • Template looks like it was made in Word: Professional labs have standardized formats

I have seen fake COAs that are literally photoshopped. Always verify independently if possible.

Last edited: May 3, 2024 at 6:23 AM
5 0Dr.ReproEndo, lucas_SP_BR, lisa_labSD and 2 others
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RegAffairsDC
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May 3, 2024 at 3:03 AM#9

Following on from GraceAZ_72 — and this may be the naive question:

Why two laboratories report different purity for the same batch, and which number to believe?

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wendy_avl
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May 3, 2024 at 6:13 AM#10

Closing the loop on my own question.

Purity and content being different measurements was the piece I was missing. The vial was overfilled and pure, which is a very different problem from the one I thought I had.

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