🍪 CompoundTalk uses cookies to improve your experience, analyze traffic, and personalize content. By continuing to use this site, you agree to our Cookie Policy.
Evidence-based GLP-1 & peptide discussion since 2023
ForumsCOA & Analytical TestingSterility testing per USP <71> — need advice Page 2

Sterility testing per USP <71> — need advice

Dr.RaviCardio Thu, Apr 9, 2026 at 9:46 AM 13 replies 672 viewsPage 2 of 3
Dr.ObesityMed
VIP Member
3,456
19,234
Nov 2023
Denver, CO
Online
Apr 9, 2026 at 10:16 PM#6
NurseKim_ATL said:
They are not contradictory, they measure different things, and this is the single most common misreading of a certificate.

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.

10 5EndoResFellow, PharmacoVig_BOS, SurmountFan_IN and 7 others
Reply Quote Save Share Report
TrialTracker_MD
Senior Member
2,345
15,678
Jan 2024
Maryland
Apr 10, 2026 at 3:13 AM#7
Dr.RaviCardio said:
Two reports on the same product from two laboratories, four percentage points apart, and no method stated on either.

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: 14.6 minutes (consistent with semaglutide reference standard)
Peak purity: 99.3%
Related substances: 0.4% (single impurity at 8.1 minutes — likely a synthesis intermediate)
Mass spec: m/z 4113.58 (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.

9 4stefan_berlin, Dr.EM_Chicago, pete_RVA and 6 others
Reply Quote Save Share Report
Dr.SurgeonPGH
Senior Member
1,345
6,789
Mar 2024
Pittsburgh, PA
Apr 10, 2026 at 8:11 AM#8
Dr.ObesityMed said:
I am more sceptical of certificates as a category than this thread is.

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: 99.2% purity, 0.0% total related substances. Clean chromatogram with single sharp peak at expected retention time. Exactly what you want to see.

8 3PharmHunterJen, TomTeleRx, DoseLogDan and 5 others
Reply Quote Save Share Report

Sigma-Aldrich — Research-Grade Standards

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

Shop Reference Standards
RegAffairsDC
Member
678
3,456
May 2024
Washington, DC
Apr 10, 2026 at 1:09 PM#9

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

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

Last edited: Apr 10, 2026 at 3:09 PM
7 2sean_dublin, hannah_MT, Dr.SportsMedIN and 4 others
Reply Quote Save Share Report
Dr.RaviCardio
VIP Member
2,890
15,678
Jan 2024
New York, NY
Apr 11, 2026 at 12:58 PM#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.

9 7jason_sac26, chris_chi24, tampaLisa73 and 6 others
Reply Quote Save Share Report

Similar Threads

HPLC vs UPLC for peptide purity — method comparison study18 replies
Mass spectrometry for peptide identity verification — ESI-MS guide7 replies
Endotoxin testing methods — LAL vs recombinant Factor C17 replies
Red flags on COAs — how to spot a fake certificate5 replies
USP reference standards for peptide verification — sourcing guide3 replies
ForumsNewTrendingMembersAccount

Log In

Forgot password?
No account? Register