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

Sterility testing per USP <71> — need advice

maya_sedona Sat, Aug 17, 2024 at 1:10 PM 15 replies 1,956 viewsPage 1 of 3
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maya_sedona
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Sedona, AZ
Aug 17, 2024 at 1:10 PM#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.

The question I want answered is why two laboratories report different purity for the same batch, and which number to believe.

Numbers rather than impressions, if you have them.

26 21wanda_boise, NurseAsh_DET, BenResearch_OR and 23 others
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mike_nyc
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Aug 17, 2024 at 1:16 PM#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: Aug 17, 2024 at 5:16 PM
25 20stefan_berlin, Dr.EM_Chicago, pete_RVA and 22 others
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LipidDoc_ATL
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Aug 17, 2024 at 1:22 PM#3
mike_nyc said:
They are not contradictory, they measure different things, and this is the single most common misreading of a certificate.

That is correct as far as it goes, and here is where it stops going. 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.

24 19AttorneyGrant, DebRD_ATL, KristenIndy and 21 others
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kevin_tulsa
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Aug 17, 2024 at 1:28 PM#4
maya_sedona 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…

Can confirm the pattern maya_sedona describes. 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.

23 18quinn_sf, NurseLeah_Nash, gary_naperville and 20 others
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GenomicsKate
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Aug 17, 2024 at 2:00 PM#5

From the other side of the consultation, briefly.

My vendor review relevant to certificates of analysis: ordered 5 times from my current compounder. Consistency has been excellent.

Shipping: Same-day local pickup
Packaging: Professional, discreet, proper labeling with lot/batch numbers
Purity: 97.6% average across orders (Janoshik verified)
Customer service: Responsive within 6 hours
Price: $150/month for semaglutide 2.4mg equivalent

Last edited: Aug 17, 2024 at 7:00 PM
22 17claudia_zurich, nancy_portland, rick_sfbay and 19 others
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