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ForumsCOA & Analytical TestingHow to commission independent testing — need advice

How to commission independent testing — need advice

wendy_avl Thu, May 2, 2024 at 11:19 PM 18 replies 2,066 viewsPage 1 of 4
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wendy_avl
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Oct 2024
Asheville, NC
May 2, 2024 at 11:19 PM#1

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

The question I want answered is whether a purity figure and a content figure can disagree without one of them being wrong.

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

12 7SleepFixSam, PurityPaulOR, MaxMetOK and 9 others
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pete_manc_UK
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Mar 2024
Manchester, UK
May 2, 2024 at 11:27 PM#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.

If somebody has the primary source to hand I would rather cite it than paraphrase it.

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GraceAZ_72
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Tucson, AZ
May 2, 2024 at 11:35 PM#3
pete_manc_UK said:
The provenance questions are more useful than the numbers.

Agreeing with pete_manc_UK, and the qualification matters more than the agreement. 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.

Last edited: May 3, 2024 at 3:35 AM
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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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MaxMetOK
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Dec 2024
Oklahoma
May 2, 2024 at 11:43 PM#4
wendy_avl 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. 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.

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TinaHashiRN
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Raleigh, NC
May 3, 2024 at 12:23 AM#5

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

Mass spectrometry confirmation for certificates of analysis: beyond HPLC purity, mass spec tells you the molecule's exact molecular weight. This confirms identity — not just purity.

Why this matters: HPLC can show you a "pure" compound, but if it's pure of the WRONG compound, purity is meaningless. Mass spec at m/z 4113.58 Da confirms it's actually semaglutide. My Janoshik report includes both HPLC and mass spec.

If your testing provider only offers HPLC, consider upgrading to include mass spec for at least your first batch from a new vendor.

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