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ForumsCOA & Analytical TestingBatch-to-batch purity variation — looking for input Page 4

Batch-to-batch purity variation — looking for input

Dr.EndoIndy Mon, May 26, 2025 at 6:39 AM 17 replies 1,487 viewsPage 4 of 4
Dr.Martinez
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Jun 1, 2025 at 6:15 AM#16

Adding the clinical framing, because it changes how the question reads.

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: 99.4% purity
Day 14: 98.6% 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.

Last edited: Jun 1, 2025 at 11:15 AM
20 18AttorneyGrant, DebRD_ATL, KristenIndy and 17 others
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zoe_NC
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Jun 1, 2025 at 8:23 AM#17
Dr.AddMedPHL 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.

21 19FranDenver, Dr.BariatricHTX, LindaRN_retired and 18 others
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GenomicsKate
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Jun 1, 2025 at 10:31 AM#18
Dr.AddMedPHL 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:…

Thank you — that is the clearest version of this I have read, and I have read a lot of them.

22 20MarkLI_maint, Dr.PeteFamMed, claudia_zurich and 19 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
hans_munich
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Jun 1, 2025 at 12:39 PM#19

From the other side of the consultation, briefly.

Community-verified vendors for certificates of analysis: I maintain a spreadsheet of Janoshik-verified test results submitted by community members. Across 54 submitted tests:

  • 82% tested at ≥98% purity
  • 12% tested at 95-98% purity
  • 6% tested at <95% purity (concerning)

The vendors with consistently high purity results are listed in the Vendor Directory. We update monthly based on new community submissions.

23 21tammy_FL, Dr.LipidDallas, alex_tucson and 20 others
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Admin
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Jun 1, 2025 at 2:47 PM#20

Moderator note: a couple of off-topic posts removed. No action needed from anybody.

45 18PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 42 others
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