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ForumsCOA & Analytical TestingSterility testing per USP <71> — need advice Page 2

Sterility testing per USP <71> — need advice

maya_sedona Sat, Aug 17, 2024 at 1:10 PM 15 replies 1,956 viewsPage 2 of 3
LabKate
Senior Member
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Aug 17, 2024 at 2:32 PM#6
LarryQC_SD said:
The provenance questions are more useful than the numbers.

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.

21 16JenMemphis, pat_auckland, Dr.GastroMayo and 18 others
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VendorMark
Senior Member
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Texas
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Aug 17, 2024 at 3:04 PM#7
maya_sedona 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 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: 97.7% average across orders (Janoshik verified)
Customer service: Responsive within 1 hours
Price: $135/month for semaglutide 2.4mg equivalent

20 15KristenIndy, MarkLI_maint, Dr.PeteFamMed and 17 others
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sean_dublin
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Dublin, IE
Aug 17, 2024 at 3:36 PM#8
LabKate 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: 99.7% purity, 0.3% total related substances. Clean chromatogram with single sharp peak at expected retention time. Exactly what you want to see.

19 14gary_naperville, sean_dublin, hannah_MT and 16 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.

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DeniseRN_TPA
Member
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Aug 2024
Tampa, FL
Aug 17, 2024 at 4:08 PM#9

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

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

18 13LindaRN_retired, tommy_boulder, hyun_seoul and 15 others
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maya_sedona
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Sedona, AZ
Aug 17, 2024 at 6:40 PM#10

Reporting back.

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.

22 20Dr.RaviCardio, jennifer_SEA, tyler_CSCS and 19 others
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