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

Sterility testing per USP <71> — need advice

Dr.RaviCardio Thu, Apr 9, 2026 at 9:46 AM 13 replies 672 viewsPage 1 of 3
Dr.RaviCardio
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Apr 9, 2026 at 9:46 AM#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.

So the question, as narrowly as I can put it: why two laboratories report different purity for the same batch, and which number to believe.

I have searched first, so if this is covered somewhere point me at it and I will read it.

15 10pete_manc_UK, anna.melb_AU, mark_tokyo and 12 others
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Dr.BariatricHTX
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Apr 9, 2026 at 10:38 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.

14 9pete_RVA, CarlaRPh_TPA, steph_laguna and 11 others
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KetoKyle
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Apr 9, 2026 at 11:30 AM#3
Dr.BariatricHTX said:
They are not contradictory, they measure different things, and this is the single most common misreading of a certificate.

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.

13 8pat_auckland, Dr.GastroMayo, JakeBK_lifts and 10 others
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sarah_TO
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Apr 9, 2026 at 12:22 PM#4
Dr.RaviCardio 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. 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.

12 7carl_compliance, DanielChem_CHI, marco_milano and 9 others
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newstart_MO
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Apr 9, 2026 at 5:19 PM#5

From the other side of the consultation, briefly.

My vendor review relevant to certificates of analysis: ordered 4 times from my current compounder. Consistency has been excellent.

Shipping: 2-day priority with gel ice
Packaging: Professional, discreet, proper labeling with lot/batch numbers
Purity: 97.5% average across orders (Janoshik verified)
Customer service: Responsive within 4 hours
Price: $133/month for semaglutide 2.4mg equivalent

11 6RunnerRach, TrialNerd_Beth, HPLC_Greg and 8 others
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