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ForumsCOA & Analytical TestingBatch-to-batch purity variation — looking for input Page 4

Batch-to-batch purity variation — looking for input

anders_CPH Fri, Aug 30, 2024 at 7:28 AM 19 replies 2,061 viewsPage 4 of 4
carl_compliance
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Raleigh, NC
Sep 1, 2024 at 2:11 PM#16

Clinical perspective, offered as context rather than as advice.

Community-verified vendors for certificates of analysis: I maintain a spreadsheet of Janoshik-verified test results submitted by community members. Across 48 submitted tests:

  • 85% tested at ≥98% purity
  • 10% tested at 95-98% purity
  • 5% 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: Sep 1, 2024 at 5:11 PM
33 6labquiet_amy, emily_PDX, Dr.SleepRoch and 30 others
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jennifer_SEA
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Seattle, WA
Sep 1, 2024 at 7:58 PM#17
lisa_labSD said:
My vendor review relevant to certificates of analysis: ordered 5 times from my current compounder.

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 the refrigerator.

Day 1: 99.0% purity
Day 14: 98.3% purity
Day 28: 98.4% purity

Minimal degradation over 28 days when properly refrigerated. This confirms the standard 28-day beyond-use date is appropriate. Beyond 28 days, I'd reconstitute a fresh vial to be safe.

34 7Dr.ReproEndo, lucas_SP_BR, lisa_labSD and 31 others
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SarahChen_PharmD
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Sep 2, 2024 at 1:45 AM#18
lisa_labSD said:
My vendor review relevant to certificates of analysis: ordered 5 times from my current compounder.

Thank you — that is the clearest version of this I have read, and I have read a lot of them.

35 8paul_denver, TinaHashiRN, robert_kc and 32 others
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paige_pharma
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Sep 2024
Omaha, NE
Sep 2, 2024 at 7:31 AM#19

Adding the clinical framing, because it changes how the question reads.

Vendor quality matters when discussing certificates of analysis. I've tested my last 4 batches through Janoshik and purity has ranged from 97.1% to 100.5%. 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.

36 9lisa_labSD, adam_van, Dr.SurgeonPGH and 33 others
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mike_mod
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Sep 2, 2024 at 1:17 PM#20

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.

8 6PurityPaulOR, MaxMetOK, MounjBrad and 5 others
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