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ForumsCOA & Analytical TestingHow to read a Certificate of Analysis — complete guide Page 4

How to read a Certificate of Analysis — complete guide

COA_Karl Mon, Feb 26, 2024 at 4:00 PM 245 replies 11,691 viewsPage 4 of 20
tampaLisa73
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Mar 1, 2024 at 10:20 AM#16
Dr.Martinez said:
My vendor review relevant to certificates of analysis: ordered 4 times from my current compounder.

Can confirm. Same sequence, different timescale.

Last edited: Mar 1, 2024 at 11:20 AM
40 13RunnerRach, TrialNerd_Beth, HPLC_Greg and 37 others
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GraceAZ_72
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Mar 1, 2024 at 2:05 PM#17

A narrower follow-up, since the general answer is now clear:

How would you tell the difference between that and the alternative explanation?

41 14CryptoCarl, MariaRD, AussieAnna and 38 others
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CryptoCarl
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Mar 1, 2024 at 5:50 PM#18
Dr.RaviCardio said:
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…

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.

42 15AussieAnna, BethLabQueen, ChrisMacros and 39 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.

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PurityPaulOR
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Mar 1, 2024 at 9:35 PM#19
Dr.RaviCardio said:
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…

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: 99.5% purity, 0.1% total related substances. Clean chromatogram with single sharp peak at expected retention time. Exactly what you want to see.

43 16Dr.Martinez, mike_mod, SarahChen_PharmD and 40 others
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mike_mod
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Mar 2, 2024 at 1:19 AM#20

Moderator note: leaving this open. It is being argued well and the disagreement is the useful part. Report rather than reply if it drifts again.

Last edited: Mar 2, 2024 at 3:19 AM
15 13PurityPaulOR, MaxMetOK, MounjBrad and 12 others
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