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ForumsCOA & Analytical TestingHas anyone dealt with moisture content analysis for lyophilized peptides? Page 3

Has anyone dealt with moisture content analysis for lyophilized peptides?

newstart_MO Thu, May 30, 2024 at 8:42 AM 54 replies 2,788 viewsPage 3 of 11
LarryQC_SD
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Jan 2024
San Diego, CA
Jun 3, 2024 at 9:05 PM#11
sean_dublin 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:…

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, 0.1% total related substances. Clean chromatogram with single sharp peak at expected retention time. Exactly what you want to see.

Last edited: Jun 3, 2024 at 10:05 PM
28 1NurseKim_ATL, paul_denver, TinaHashiRN and 25 others
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emily_PDX
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Nov 2024
Portland, OR
Jun 6, 2024 at 11:52 AM#12
paige_pharma said:
Agreed, and mass spec answers a question purity does not: identity.

Bookmarking. The distinction being drawn above is the one nobody else makes. Printing the relevant bit and taking it with me.

29 2PharmD_Rodriguez, julia.endo, JessicaM_2024 and 26 others
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Dr.CardioMD
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Jun 9, 2024 at 2:38 AM#13
sean_dublin 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.

30 3tony_orlando, Dr.NephBHM_UK, kim_atl_prep and 27 others
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PeptideMeter — Independent Peptide Analytics

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bri_stats
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May 2024
Seattle, WA
Jun 11, 2024 at 5:23 PM#14
newstart_MO 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…

Community-verified vendors for certificates of analysis: I maintain a spreadsheet of Janoshik-verified test results submitted by community members. Across 46 submitted tests:

  • 82% tested at ≥98% purity
  • 12% tested at 95-98% purity
  • 6% tested at <95% purity (concerning)

The vendors with consistently high purity results are listed in the Vendor Directory. We update monthly based on new community submissions.

Last edited: Jun 11, 2024 at 9:23 PM
31 4JessicaM_2024, TomFromTexas, mike.trainer_LA and 28 others
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mike_mod
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Jun 14, 2024 at 8:06 AM#15

Moderator note: two posts asking for a source have been merged into one. Please search the thread before asking again. No action needed from anybody.

32 5PurityPaulOR, MaxMetOK, MounjBrad and 29 others
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