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ForumsCOA & Analytical TestingIs 98% purity actually good or should I be worried — need advice Page 2

Is 98% purity actually good or should I be worried — need advice

Dr.CardioMD Tue, Jan 9, 2024 at 10:22 AM 14 replies 2,095 viewsPage 2 of 3
CarlaRPh_TPA
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Jan 9, 2024 at 2:19 PM#6
DanielChem_CHI 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.

I would rather be corrected than agreed with, if it comes to it.

4 24FDA_TrackerJim, ricardo_MIA, BrianDallas92 and 1 other
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hank_denver
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Jan 9, 2024 at 3:52 PM#7
Dr.CardioMD said:
Two reports on the same product from two laboratories, four percentage points apart, and no method stated on either.

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: 99.4% purity, 0.0% total related substances. Clean chromatogram with single sharp peak at expected retention time. Exactly what you want to see.

3 23raj_cambridge, ingrid_STO, pete_nash
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NurseLeah_Nash
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Jan 9, 2024 at 5:25 PM#8
CarlaRPh_TPA said:
I am more sceptical of certificates as a category than this thread is.

COA red flags for certificates of analysis — here's what to look for when reviewing a Certificate of Analysis:

  • No HPLC data: If there's no chromatography graph, it's not a real COA
  • Exact 100% purity: Suspicious — real testing always shows slight variation
  • No batch number: Can't trace back to specific production
  • No endotoxin testing: For injectables, this is essential
  • Template looks like it was made in Word: Professional labs have standardized formats

I have seen fake COAs that are literally photoshopped. Always verify independently if possible.

2 22PeptideSynthNJ, Dr.KarenChen
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nancy_portland
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Jan 9, 2024 at 6:58 PM#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?

Last edited: Jan 9, 2024 at 7:58 PM
1 21Dr.PeteFamMed
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Dr.CardioMD
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Jan 10, 2024 at 2:26 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: Jan 10, 2024 at 8:26 AM
49 22josh_phd_bmore, roxy_nash, tony_orlando and 46 others
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