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ForumsCOA & Analytical TestingEndotoxin testing methods — what worked for you? Page 2

Endotoxin testing methods — what worked for you?

Dr.KarenChen Mon, Apr 27, 2026 at 4:22 AM 15 replies 838 viewsPage 2 of 3
quinn_sf
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Apr 28, 2026 at 1:56 AM#6
Dr.KarenChen said:
Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself…

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.

3 23tane_welly, Dr.PathRoch, mona_PHX
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denise_HTX
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Apr 28, 2026 at 10:30 AM#7

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

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

Last edited: Apr 28, 2026 at 12:30 PM
2 22NeuroNate, JessicaH_TX
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Dr.EM_Chicago
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Apr 28, 2026 at 7:04 PM#8
quinn_sf said:
Mass spectrometry confirmation for certificates of analysis: beyond HPLC purity, mass spec tells you the molecule's exact molecular weight.

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: 98.3% purity
Day 28: 99.2% 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: Apr 28, 2026 at 11:04 PM
1 21Dr.ReproEndo
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Dr.KarenChen
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Apr 29, 2026 at 3:38 AM#9

OP back with an update, since a thread like this is useless without one.

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.

50 20mike.trainer_LA, sarah_nash92, FitDadDave and 47 others
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marcus_mpls
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Apr 30, 2026 at 8:44 PM#10
Dr.EM_Chicago 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…

Agreeing with Dr.EM_Chicago, and the qualification matters more than the agreement. One addition: an unstated method makes a report close to uninterpretable. "99% pure" without the technique, the standard and the conditions is a claim, not a measurement.

Last edited: May 1, 2026 at 1:44 AM
26 24mona_PHX, andrew_nyc, Dr.EndoEP and 23 others
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