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Evidence-based GLP-1 & peptide discussion since 2023
ForumsCOA & Analytical TestingHas anyone dealt with moisture content analysis for lyophilized peptides? Page 2

Has anyone dealt with moisture content analysis for lyophilized peptides?

newstart_MO Thu, May 30, 2024 at 8:42 AM 54 replies 2,788 viewsPage 2 of 11
Dr.ReproEndo
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May 30, 2024 at 7:53 PM#6
JessicaH_TX said:
Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself…

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.

16 11mona_PHX, andrew_nyc, Dr.EndoEP and 13 others
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Dr.PathRoch
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May 31, 2024 at 12:18 AM#7
newstart_MO said:
Two reports on the same product from two laboratories, four percentage points apart, and no method stated on either.

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: 100.3% purity
Day 14: 99.4% purity
Day 28: 98.1% 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.

15 10InsuranceTom, WendyG_ATL, SaraMom3 and 12 others
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PharmacoVig_BOS
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May 31, 2024 at 4:43 AM#8
Dr.ReproEndo said:
I am more sceptical of certificates as a category than this thread is.

I tested my certificates of analysis batch through Janoshik — 97.3% purity. That's within acceptable range for compounded peptides. Turnaround was 14 business days.

The test costs ~$132 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.

Last edited: May 31, 2024 at 7:43 AM
14 9DataDave, Dr.GutHealth, amsterdam_pete and 11 others
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Sigma-Aldrich — Research-Grade Standards

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tony_orlando
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Orlando, FL
May 31, 2024 at 9:07 AM#9

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

Whether a purity figure and a content figure can disagree without one of them being wrong?

13 8CanadaChris, ZaraB_AL, JakeSmashed95 and 10 others
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newstart_MO
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Springfield, MO
Jun 1, 2024 at 6:16 AM#10

Reporting back.

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.

Last edited: Jun 1, 2024 at 12:16 PM
27 0RunnerRach, TrialNerd_Beth, HPLC_Greg and 24 others
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