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Evidence-based GLP-1 & peptide discussion since 2023
ForumsCOA & Analytical TestingUSP reference standards for peptide verification — anyone have experience? Page 3

USP reference standards for peptide verification — anyone have experience?

lisa_labSD Tue, Sep 24, 2024 at 11:05 AM 13 replies 1,991 viewsPage 3 of 3
Dr.RaviCardio
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Sep 26, 2024 at 9:10 AM#11
Dr.NephBHM_UK said:
My HPLC chromatogram analysis for certificates of analysis — I sent my batch to Janoshik and here's what the results showed: Main peak retention time:…

Reconstituted peptide stability data for certificates of analysis: I had Janoshik test my reconstituted vial at day 1, day 14, and day 28 stored in the refrigerator.

Day 1: 99.0% purity
Day 14: 98.1% purity
Day 28: 97.0% purity

Minimal degradation over 28 days when properly refrigerated. This confirms the standard 28-day beyond-use date is appropriate. Beyond 28 days, I'd reconstitute a fresh vial to be safe.

11 9pete_manc_UK, anna.melb_AU, mark_tokyo and 8 others
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maya_sedona
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Sep 27, 2024 at 5:04 PM#12
tom_AK said:
Agreed, and mass spec answers a question purity does not: identity.

Thank you — that is the clearest version of this I have read, and I have read a lot of them. I will report back once I have actually tried it.

Last edited: Sep 27, 2024 at 9:04 PM
12 10NurseAsh_DET, BenResearch_OR, MikeKY_noInsulin and 9 others
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TrialNerd_Beth
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Sep 29, 2024 at 12:58 AM#13
Dr.NephBHM_UK said:
My HPLC chromatogram analysis for certificates of analysis — I sent my batch to Janoshik and here's what the results showed: Main peak retention time:…

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.

13 11TomTeleRx, DoseLogDan, SleepFixSam and 10 others
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Sigma-Aldrich — Research-Grade Standards

Certified reference materials, analytical reagents, and research-grade standards for peptide verification. Trusted by laboratories worldwide.

Shop Reference Standards
FDA_TrackerJim
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Sep 30, 2024 at 8:51 AM#14
lisa_labSD 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…

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: Sep 30, 2024 at 11:51 AM
14 12Dr.LeslieOBGYN, MikeNYC_runner and 11 others
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Admin
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Oct 1, 2024 at 4:43 PM#15

Moderator note: leaving this open. It is being argued well and the disagreement is the useful part. Thread quality here is what the rules are for. Keep it up.

15 13PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 12 others
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