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

Sterility testing per USP <71> — need advice

AmyNC_wife Tue, Dec 2, 2025 at 6:54 PM 11 replies 1,136 viewsPage 1 of 3
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AmyNC_wife
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Dec 2, 2025 at 6:54 PM#1

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

The four things to check on any report, in order: does it name your batch, who commissioned it, what method was used, and does it report content as well as purity. A report failing any of those is weak evidence regardless of the percentage on it.

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

If the honest answer is that nobody knows, that is a useful answer and I would rather have it.

44 14JessicaM_2024, TomFromTexas, mike.trainer_LA and 41 others
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PeptideChemSF
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Dec 2, 2025 at 7:02 PM#2

Taking the question as asked, rather than the general version of it. 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.

43 13dave_SLC, FDA_TrackerJim, ricardo_MIA and 40 others
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VanRx_Mike
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Dec 2, 2025 at 7:10 PM#3
PeptideChemSF said:
They are not contradictory, they measure different things, and this is the single most common misreading of a certificate.

No disagreement with PeptideChemSF. One condition attached. 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: Dec 2, 2025 at 10:10 PM
42 12Admin, Dr.Martinez, mike_mod and 39 others
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roxy_nash
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Dec 2, 2025 at 7:18 PM#4
AmyNC_wife 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. 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.

Last edited: Dec 3, 2025 at 1:18 AM
41 11Dr.NephBHM_UK, kim_atl_prep, sarah_TO and 38 others
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Dr.SurgeonPGH
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Dec 2, 2025 at 7:57 PM#5

From the other side of the consultation, briefly.

Vendor quality matters when discussing certificates of analysis. I've tested my last 6 batches through Janoshik and purity has ranged from 98.5% to 100.3%. Consistency is key.

For anyone new: always request the COA, and consider independent verification. The $300 for a Janoshik test is worth the peace of mind.

40 10B12Beth, RickReta_CO, PharmHunterJen and 37 others
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