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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

sarah_TO Fri, May 16, 2025 at 12:02 PM 13 replies 1,420 viewsPage 3 of 3
Dr.RaviCardio
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May 17, 2025 at 11:42 AM#11
andrew_nyc said:
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…

Vendor quality matters when discussing certificates of analysis. I've tested my last 3 batches through Janoshik and purity has ranged from 97.4% to 99.0%. Consistency is key.

For anyone new: always request the COA, and consider independent verification. The $300 for a Janoshik test is worth the peace of mind.

Last edited: May 17, 2025 at 12:42 PM
10 8pete_manc_UK, anna.melb_AU, mark_tokyo and 7 others
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NauseaFreeNow
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May 17, 2025 at 4:25 PM#12
VanRx_Mike said:
Agreed, and mass spec answers a question purity does not: identity.

Thank you — that is the clearest version of this I have read, and I have read a lot of them. I will report back once I have actually tried it.

11 9maya_sedona, stefan_berlin, Dr.EM_Chicago and 8 others
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JenMemphis
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May 17, 2025 at 9:08 PM#13
andrew_nyc said:
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…

My vendor review relevant to certificates of analysis: ordered 6 times from my current compounder. Consistency has been excellent.

Shipping: 3-day with temperature monitor
Packaging: Professional, discreet, proper labeling with lot/batch numbers
Purity: 98.7% average across orders (Janoshik verified)
Customer service: Responsive within 1 hours
Price: $127/month for tirzepatide 10mg equivalent

Last edited: May 18, 2025 at 2:08 AM
12 10NurseAsh_DET, BenResearch_OR, MikeKY_noInsulin and 9 others
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lucas_SP_BR
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May 18, 2025 at 1:51 AM#14
sarah_TO said:
Two reports on the same product from two laboratories, four percentage points apart, and no method stated on either.

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: 99.4% purity, 0.0% total related substances. Clean chromatogram with single sharp peak at expected retention time. Exactly what you want to see.

13 11KarenAZ_mom, zoe_NC, Dr.ObesityLA and 10 others
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Admin
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May 18, 2025 at 6:34 AM#15

Moderator note: good thread. Keeping it here rather than moving it, because the question is general enough to be useful. Report rather than reply if it drifts again.

Last edited: May 18, 2025 at 10:34 AM
14 12PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 11 others
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