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ForumsCOA & Analytical TestingIs 98% purity actually good or should I be worried — need advice

Is 98% purity actually good or should I be worried — need advice

Dr.CardioMD Tue, Jan 9, 2024 at 10:22 AM 14 replies 2,095 viewsPage 1 of 3
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Dr.CardioMD
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Jan 9, 2024 at 10:22 AM#1

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 contradictory.

So the question, as narrowly as I can put it: whether a purity figure and a content figure can disagree without one of them being wrong.

Tell me what I have not thought of.

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kate.chem
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Jan 9, 2024 at 10:39 AM#2

Answering the narrow version, because the broad one does not have a single answer. 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.

I would rather be corrected than agreed with, if it comes to it.

Last edited: Jan 9, 2024 at 1:39 PM
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Dr.RenalNash
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Jan 9, 2024 at 10:56 AM#3
kate.chem said:
The provenance questions are more useful than the numbers.

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.

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Dr.LeslieOBGYN
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Jan 9, 2024 at 11:13 AM#4
Dr.CardioMD 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…

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.

Last edited: Jan 9, 2024 at 5:13 PM
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chris_chi24
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Jan 9, 2024 at 12:46 PM#5

Clinical perspective, offered as context rather than as advice.

My HPLC chromatogram analysis for certificates of analysis — I sent my batch to Janoshik and here's what the results showed:

Main peak retention time: 14.6 minutes (consistent with semaglutide reference standard)
Peak purity: 98.0%
Related substances: 0.4% (single impurity at 8.0 minutes — likely a synthesis intermediate)
Mass spec: m/z 4113.58 (matches expected molecular weight)

This is a clean result. The mass spec confirmation is particularly important — it proves the molecule is actually semaglutide and not a substitution.

Last edited: Jan 9, 2024 at 3:46 PM
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