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

Batch-to-batch purity variation — looking for input

Dr.EndoIndy Mon, May 26, 2025 at 6:39 AM 17 replies 1,487 viewsPage 1 of 4
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Dr.EndoIndy
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May 26, 2025 at 6:39 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.

What I am after is why two laboratories report different purity for the same batch, and which number to believe.

I would rather have one careful answer than five confident ones.

44 14mia_MS2, LeilaHI, marcus_mpls and 41 others
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BenResearch_OR
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May 26, 2025 at 8:47 AM#2

Short answer first, then the reasoning. 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 26, 2025 at 9:47 AM
43 13PharmD_Rodriguez, julia.endo, JessicaM_2024 and 40 others
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NurseKim_ATL
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May 26, 2025 at 10:55 AM#3
BenResearch_OR said:
They are not contradictory, they measure different things, and this is the single most common misreading of a certificate.

BenResearch_OR 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.

Last edited: May 26, 2025 at 3:55 PM
42 12ingrid_STO, pete_nash, hank_denver and 39 others
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JakeSmashed95
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May 26, 2025 at 1:03 PM#4
Dr.EndoIndy 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. 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 11Dr.LipidDallas, alex_tucson, kevin_tulsa and 38 others
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Dr.ReproEndo
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May 27, 2025 at 1:46 AM#5

From the other side of the consultation, briefly.

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: 15.2 minutes (consistent with semaglutide reference standard)
Peak purity: 98.7%
Related substances: 0.6% (single impurity at 9.2 minutes — likely a synthesis intermediate)
Mass spec: m/z 4113.6 (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: May 27, 2025 at 2:46 AM
40 10carl_compliance, DanielChem_CHI, marco_milano and 37 others
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