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ForumsCOA & Analytical TestingWhat even IS a COA and why should I care — my results so far Page 2

What even IS a COA and why should I care — my results so far

Dr.MetabolicMD Thu, Mar 7, 2024 at 4:44 PM 9 replies 2,096 viewsPage 2 of 2
bri_stats
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Mar 7, 2024 at 11:25 PM#6
Dr.MetabolicMD said:
Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself…

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: 99.7% purity, 0.1% total related substances. Clean chromatogram with single sharp peak at expected retention time. Exactly what you want to see.

Last edited: Mar 8, 2024 at 3:25 AM
28 23sarah_nash92, FitDadDave, RunnerRach and 25 others
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KarenAZ_mom
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Mar 8, 2024 at 2:02 AM#7

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

Why two laboratories report different purity for the same batch, and which number to believe?

Last edited: Mar 8, 2024 at 7:02 AM
27 22pete_manc_UK, anna.melb_AU, mark_tokyo and 24 others
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carl_compliance
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Mar 8, 2024 at 4:39 AM#8
bri_stats said:
HPLC results interpretation for certificates of analysis: when you get your Janoshik report back, here's what the numbers mean: Purity %: Should be…

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: 98.3% 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: Mar 8, 2024 at 7:39 AM
26 21ricardo_MIA, BrianDallas92, labquiet_amy and 23 others
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Dr.MetabolicMD
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Mar 8, 2024 at 7:16 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.

25 20Dr.ObesityMed, HealthEcon_DC, PedsEndoPhilly and 22 others
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CanadaChris
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Mar 8, 2024 at 7:52 PM#10
carl_compliance 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 carl_compliance, 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.

5 3lori_vegas, Dr.PulmRoch, maya_sedona and 2 others
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