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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
DanielChem_CHI
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Aug 30, 2024 at 12:23 PM#6
DataDave said:
The provenance questions are more useful than the numbers.

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 2:23 PM
16 11fiona_VT, denise_HTX, raj_cambridge and 13 others
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Dr.NateNeph
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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…

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

  • Janoshik: Gold standard for peptide community, ~$144, 10-14 day turnaround
  • Valitech: US-based, ISO 17025 accredited, ~$224
  • Eurofins: Full pharmaceutical testing suite, more expensive but comprehensive
  • ChemTox: Basic identity and purity testing, ~$114

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: Aug 30, 2024 at 4:19 PM
15 10NauseaFreeNow, SteveThurs, B12Beth and 12 others
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Dr.RenalNash
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Aug 30, 2024 at 4:15 PM#8
DanielChem_CHI said:
I am more sceptical of certificates as a category than this thread is.

My HPLC chromatogram analysis for certificates of analysis — I sent my batch to Janoshik and here's what the results showed:

Main peak retention time: 15.3 minutes (consistent with semaglutide reference standard)
Peak purity: 98.1%
Related substances: 0.7% (single impurity at 9.2 minutes — likely a synthesis intermediate)
Mass spec: m/z 4113.6 (matches expected molecular weight)

This is a clean result. The mass spec confirmation is particularly important — it proves the molecule is actually semaglutide and not a substitution.

14 9Dr.NutriCornell, pam_stl, wei_SG and 11 others
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EndoResFellow
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Aug 30, 2024 at 6:11 PM#9

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

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

Last edited: Aug 30, 2024 at 8:11 PM
13 8NurseKim_ATL, paul_denver, TinaHashiRN and 10 others
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anders_CPH
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Aug 31, 2024 at 3:29 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.

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