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ForumsCOA & Analytical TestingInter-lab variability in peptide testing — July 2024

Inter-lab variability in peptide testing — July 2024

JennaRN Fri, Apr 5, 2024 at 2:00 AM 32 replies 2,715 viewsPage 1 of 7
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JennaRN
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Apr 5, 2024 at 2:00 AM#1

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

The bit I cannot resolve on my own is why two laboratories report different purity for the same batch, and which number to believe.

Practical detail welcome, however dull — the duller the better.

42 12Dr.KarenChen, Dr.NateNeph, PharmD_Rodriguez and 39 others
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SarahChen_PharmD
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Apr 5, 2024 at 2:24 AM#2

Short answer first, then the reasoning. The provenance questions are more useful than the numbers. Does the report name the batch on your vial. Is the date consistent with when that batch existed. Is it addressed to the vendor or to the person who paid for the test. Was the sample taken from general stock or supplied by the vendor. A perfect certificate for a different batch is worth nothing, and vendor-supplied samples are the most common way a genuine report ends up misleading.

41 11NurseKim_ATL, paul_denver, TinaHashiRN and 38 others
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WendyG_ATL
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Apr 5, 2024 at 2:48 AM#3
SarahChen_PharmD said:
The provenance questions are more useful than the numbers.

SarahChen_PharmD has the substance of this right. The condition it depends on is worth stating. One addition: an unstated method makes a report close to uninterpretable. "99% pure" without the technique, the standard and the conditions is a claim, not a measurement.

40 10traveltech_sara, AttorneyGrant, DebRD_ATL and 37 others
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JessicaM_2024
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Apr 5, 2024 at 3:12 AM#4
JennaRN said:
Two reports on the same product from two laboratories, four percentage points apart, and no method stated on either.

This matches mine closely enough to be worth saying so. 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.

39 9Dr.PainCLE, mike_mealprep, NicoleRaleigh and 36 others
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LindaRN_retired
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Apr 5, 2024 at 5:20 AM#5

From the other side of the consultation, briefly.

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: 98.2% purity
Day 28: 97.0% 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.

38 8mike_nyc, VendorMark, COA_Karl and 35 others
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