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ForumsCOA & Analytical TestingBatch-to-batch purity variation — acceptable ranges Page 2

Batch-to-batch purity variation — acceptable ranges

kate.chem Sat, Jun 6, 2026 at 4:15 AM 15 replies 505 viewsPage 2 of 3
dave_SLC
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Jun 6, 2026 at 5:24 AM#6
kate.chem said:
The provenance questions are more useful than the numbers.

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.

38 8mike_mealprep, NicoleRaleigh, james_edin and 35 others
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rick_sfbay
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Jun 6, 2026 at 5:51 AM#7

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?

37 7NicoleRaleigh, james_edin, FranDenver and 34 others
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PharmHunterJen
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Jun 6, 2026 at 6:18 AM#8
dave_SLC said:
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…

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.

36 6kevin_tulsa, Dr.PainCLE, mike_mealprep and 33 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.

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kate.chem
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Jun 6, 2026 at 6:45 AM#9

Closing the loop on my own question.

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.

35 5jennifer_SEA, tyler_CSCS, VanRx_Mike and 32 others
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tom_AK
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Jun 6, 2026 at 8:54 AM#10
PharmHunterJen said:
HPLC results interpretation for certificates of analysis: when you get your Janoshik report back, here's what the numbers mean: Purity %: Should be…

Agreed, and mass spec answers a question purity does not: identity. High purity tells you one thing dominates the chromatogram, not that it is the molecule you ordered. A mass within about a dalton of expected is the identity check.

Last edited: Jun 6, 2026 at 12:54 PM
21 19Dr.RaviCardio, jennifer_SEA, tyler_CSCS and 18 others
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