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ForumsCOA & Analytical TestingBatch-to-batch purity variation — looking for input Page 2

Batch-to-batch purity variation — looking for input

anders_CPH Fri, Aug 30, 2024 at 7:28 AM 19 replies 2,061 viewsPage 2 of 4
HPLC_Greg
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Aug 30, 2024 at 12:23 PM#6
Dr.ObesityLA 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.

Last edited: Aug 30, 2024 at 6:23 PM
16 11SallyK_inj, CryptoCarl, MariaRD and 13 others
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quinn_sf
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Aug 30, 2024 at 2:19 PM#7
anders_CPH said:
I have a certificate reporting 99.2% purity and 6.1mg content on a vial sold as 5mg, and I cannot work out whether those two numbers are consistent or…

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, 0.3% total related substances. Clean chromatogram with single sharp peak at expected retention time. Exactly what you want to see.

Last edited: Aug 30, 2024 at 8:19 PM
15 10Dr.PathRoch, mona_PHX, andrew_nyc and 12 others
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Dr.GastroMayo
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Aug 30, 2024 at 4:15 PM#8
HPLC_Greg said:
I am more sceptical of certificates as a category than this thread is.

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: 99.2% purity
Day 14: 98.0% 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.

14 9COA_Karl, MikeFit_NJ, InsuranceTom and 11 others
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Sigma-Aldrich — Research-Grade Standards

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SkepticalSean
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Aug 30, 2024 at 6:11 PM#9

One thing that is still open after JessicaM_2024’s answer:

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

13 8tammy_FL, Dr.LipidDallas, alex_tucson and 10 others
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anders_CPH
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Aug 31, 2024 at 3:29 AM#10

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.

Last edited: Aug 31, 2024 at 7:29 AM
27 0ChrisMacros, KetoKyle, CanadaChris and 24 others
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