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ForumsCOA & Analytical TestingBatch-to-batch purity variation — looking for input Page 3

Batch-to-batch purity variation — looking for input

anders_CPH Fri, Aug 30, 2024 at 7:28 AM 19 replies 2,061 viewsPage 3 of 4
pete_manc_UK
Senior Member
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Mar 2024
Manchester, UK
Aug 31, 2024 at 9:16 AM#11
Dr.RenalNash said:
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:…

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: Aug 31, 2024 at 3:16 PM
28 1TrialNerd_Beth, HPLC_Greg, LibrarianMeg and 25 others
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MariaRD
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Jun 2024
New Mexico
Aug 31, 2024 at 3:03 PM#12
FranDenver said:
One addition: an unstated method makes a report close to uninterpretable.

Genuinely useful, thank you. I had the facts and not the framework. Adding it to my notes with a link back to this thread.

Last edited: Aug 31, 2024 at 4:03 PM
29 2anders_CPH, Dr.NutriCornell, pam_stl and 26 others
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Dr.SportsMedIN
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Indianapolis, IN
Aug 31, 2024 at 8:50 PM#13
Dr.RenalNash said:
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:…

Mass spectrometry confirmation for certificates of analysis: beyond HPLC purity, mass spec tells you the molecule's exact molecular weight. This confirms identity — not just purity.

Why this matters: HPLC can show you a "pure" compound, but if it's pure of the WRONG compound, purity is meaningless. Mass spec at m/z 4113.58 Da confirms it's actually semaglutide. My Janoshik report includes both HPLC and mass spec.

If your testing provider only offers HPLC, consider upgrading to include mass spec for at least your first batch from a new vendor.

30 3adam_van, Dr.SurgeonPGH, rachel_ABQ and 27 others
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PeptideMeter — Independent Peptide Analytics

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lisa_labSD
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Oct 2024
San Diego, CA
Sep 1, 2024 at 2:37 AM#14
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…

My vendor review relevant to certificates of analysis: ordered 5 times from my current compounder. Consistency has been excellent.

Shipping: Same-day local pickup
Packaging: Professional, discreet, proper labeling with lot/batch numbers
Purity: 98.6% average across orders (Janoshik verified)
Customer service: Responsive within 6 hours
Price: $142/month for tirzepatide 10mg equivalent

31 4lori_vegas, Dr.PulmRoch, maya_sedona and 28 others
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Admin
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Sep 1, 2024 at 8:24 AM#15

Moderator note: the sourcing question belongs in the vendor section and has been split out. No action needed from anybody.

32 5PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 29 others
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