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ForumsCOA & Analytical TestingParticulate matter testing — 6 month update Page 2

Particulate matter testing — 6 month update

SarahChen_PharmD Fri, Apr 19, 2024 at 2:09 AM 14 replies 1,992 viewsPage 2 of 3
TrialTracker_MD
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Apr 19, 2024 at 2:19 PM#6
Dr.SurgeonPGH 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: Apr 19, 2024 at 7:19 PM
23 18Dr.EM_Chicago, pete_RVA, CarlaRPh_TPA and 20 others
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josh_phd_bmore
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Apr 19, 2024 at 7:08 PM#7
SarahChen_PharmD said:
Two reports on the same product from two laboratories, four percentage points apart, and no method stated on either.

Third-party testing services for certificates of analysis besides Janoshik:

  • Janoshik: Gold standard for peptide community, ~$140, 10-14 day turnaround
  • Valitech: US-based, ISO 17025 accredited, ~$220
  • Eurofins: Full pharmaceutical testing suite, more expensive but comprehensive
  • ChemTox: Basic identity and purity testing, ~$110

Janoshik is the community standard but any ISO-accredited analytical lab can verify peptide identity and purity. The key is independence — don't rely solely on the vendor's own testing.

Last edited: Apr 19, 2024 at 9:08 PM
22 17Dr.ObesityLA, NurseKim_ATL, paul_denver and 19 others
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Dr.PeteFamMed
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Apr 19, 2024 at 11:57 PM#8
TrialTracker_MD 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.

Last edited: Apr 20, 2024 at 12:57 AM
21 16LindaRN_retired, tommy_boulder, hyun_seoul and 18 others
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KarenAZ_mom
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Apr 20, 2024 at 4:46 AM#9

One thing that is still open after B12Beth’s answer:

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

20 15LibrarianMeg, bri_stats, pete_manc_UK and 17 others
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SarahChen_PharmD
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Apr 21, 2024 at 3:53 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.

10 8robert_kc, dan_philly, MeganSA_TX and 7 others
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