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Evidence-based GLP-1 & peptide discussion since 2023
ForumsCOA & Analytical TestingSterility testing per USP <71> — need advice Page 2

Sterility testing per USP <71> — need advice

sarah_TO Fri, May 16, 2025 at 12:02 PM 13 replies 1,420 viewsPage 2 of 3
TrialNerd_Beth
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May 16, 2025 at 4:42 PM#6
VendorMark 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.

44 14RickReta_CO, PharmHunterJen, TomTeleRx and 41 others
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Dr.PeteFamMed
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Minneapolis, MN
May 16, 2025 at 6:32 PM#7
sarah_TO said:
Two reports on the same product from two laboratories, four percentage points apart, and no method stated on either.

I tested my certificates of analysis batch through Janoshik — 98.7% purity. That's within acceptable range for compounded peptides. Turnaround was 10 business days.

The test costs ~$130 but gives you actual HPLC chromatography data plus mass spec confirmation. For the peace of mind alone, it's worth every penny. I test every new batch from a new vendor.

Last edited: May 16, 2025 at 7:32 PM
43 13tommy_boulder, hyun_seoul, jim_asheville and 40 others
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andrew_nyc
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May 16, 2025 at 8:22 PM#8
TrialNerd_Beth 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.

42 12PharmD_Rodriguez, julia.endo, JessicaM_2024 and 39 others
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Sigma-Aldrich — Research-Grade Standards

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LeilaHI
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May 16, 2025 at 10:12 PM#9

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

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

Last edited: May 17, 2025 at 3:12 AM
41 11LondonLisa, mike_nyc, VendorMark and 38 others
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sarah_TO
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May 17, 2025 at 6:59 AM#10

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.

9 7DanielChem_CHI, marco_milano, pam_columbus and 6 others
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