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

Sterility testing per USP <71> — need advice

sarah_TO Fri, May 16, 2025 at 12:02 PM 13 replies 1,420 viewsPage 1 of 3
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sarah_TO
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May 16, 2025 at 12:02 PM#1

Two reports on the same product from two laboratories, four percentage points apart, and no method stated on either.

The narrow version of the question is whether a purity figure and a content figure can disagree without one of them being wrong.

Not looking for reassurance. Looking for the part I have got wrong.

49 19andrew_nyc, Dr.EndoEP, GraceAZ_72 and 46 others
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VendorMark
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May 16, 2025 at 12:22 PM#2

Answering the narrow version, because the broad one does not have a single answer. Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself calibrated, the gradient and column, the detection wavelength, and where the integration baseline was drawn. A percentage point or two between competent labs is expected. What is not expected is a large gap, and the usual explanation there is that one report is not of the batch in your hand.

Last edited: May 16, 2025 at 2:22 PM
48 18KristenIndy, MarkLI_maint, Dr.PeteFamMed and 45 others
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VanRx_Mike
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May 16, 2025 at 12:42 PM#3
VendorMark said:
Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself…

Agreed, and mass spec answers a question purity does not: identity. High purity tells you one thing dominates the chromatogram, not that it is the molecule you ordered. A mass within about a dalton of expected is the identity check.

47 17Admin, Dr.Martinez, mike_mod and 44 others
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amy_econ_NJ
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May 2024
Princeton, NJ
May 16, 2025 at 1:02 PM#4
sarah_TO said:
Two reports on the same product from two laboratories, four percentage points apart, and no method stated on either.

Same position here, arrived at the long way round. They are not contradictory, they measure different things, and this is the single most common misreading of a certificate. Purity is a relative area measurement: the main peak as a percentage of total peak area in the chromatogram. Content is an absolute mass measurement against a reference standard. A vial can be 99% pure and contain 6.1mg — pure material, overfilled — or 99% pure and contain 3mg, which is pure material and a short fill. Purity tells you what fraction of what is there is the right molecule; content tells you how much of it there is. You need both, and a certificate with only purity is telling you half the story.

Last edited: May 16, 2025 at 4:02 PM
46 16gary_naperville, sean_dublin, hannah_MT and 43 others
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Dr.DermMIA
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May 16, 2025 at 2:52 PM#5

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 60 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.

45 15SurmountFan_IN, PeptideChemSF, A1cHero_PHX and 42 others
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