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Evidence-based GLP-1 & peptide discussion since 2023
ForumsCOA & Analytical TestingSterility testing per USP <71> — need advice Page 3

Sterility testing per USP <71> — need advice

AmyNC_wife Tue, Dec 2, 2025 at 6:54 PM 11 replies 1,136 viewsPage 3 of 3
Dr.ReproEndo
Senior Member
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Jan 2024
Scottsdale, AZ
Dec 5, 2025 at 11:00 PM#11
ingrid_STO said:
Reconstituted peptide stability data for certificates of analysis: I had Janoshik test my reconstituted vial at day 1, day 14, and day 28 stored in…

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: 99.6% purity, 0.0% total related substances. Clean chromatogram with single sharp peak at expected retention time. Exactly what you want to see.

11 9mona_PHX, andrew_nyc, Dr.EndoEP and 8 others
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SleepFixSam
Member
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678
Nov 2024
Hawaii
Dec 8, 2025 at 8:17 PM#12
VanRx_Mike said:
One addition: an unstated method makes a report close to uninterpretable.

This answered a question I did not know how to ask. Sending this to two other people who asked me the same thing last week.

12 10ingrid_STO, pete_nash, hank_denver and 9 others
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SkepticalSean
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Jan 2025
Maine
Dec 11, 2025 at 5:33 PM#13
ingrid_STO said:
Reconstituted peptide stability data for certificates of analysis: I had Janoshik test my reconstituted vial at day 1, day 14, and day 28 stored in…

I tested my certificates of analysis batch through Janoshik — 97.3% purity. That's within acceptable range for compounded peptides. Turnaround was 14 business days.

The test costs ~$126 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.

13 11emma_london, tammy_FL, Dr.LipidDallas and 10 others
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Sigma-Aldrich — Research-Grade Standards

Certified reference materials, analytical reagents, and research-grade standards for peptide verification. Trusted by laboratories worldwide.

Shop Reference Standards
dave_SLC
Member
345
1,567
Aug 2024
Salt Lake City, UT
Dec 14, 2025 at 2:48 PM#14
AmyNC_wife said:
Two reports on the same product from two laboratories, four percentage points apart, and no method stated on either.

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.

14 12FranDenver, Dr.BariatricHTX, LindaRN_retired and 11 others
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Admin
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Oct 2023
Online
Dec 17, 2025 at 12:01 PM#15

Moderator note: the sourcing question belongs in the vendor section and has been split out.

15 13PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 12 others
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