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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.

What I am after is whether a purity figure and a content figure can disagree without one of them being wrong.

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

26 21wanda_boise, NurseAsh_DET, BenResearch_OR and 23 others
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LarryQC_SD
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San Diego, CA
Aug 17, 2024 at 1:16 PM#2

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

25 20paul_denver, TinaHashiRN, robert_kc and 22 others
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sophie_paris
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Paris, FR
Aug 17, 2024 at 1:22 PM#3
LarryQC_SD 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.

24 19MariaRD, AussieAnna, BethLabQueen and 21 others
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ben_calgary
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Oct 2024
Calgary, CA
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…

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: Aug 17, 2024 at 7:28 PM
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andrew_nyc
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Aug 17, 2024 at 2:00 PM#5

Clinical perspective, offered as context rather than as advice.

COA red flags for certificates of analysis — here's what to look for when reviewing a Certificate of Analysis:

  • No HPLC data: If there's no chromatography graph, it's not a real COA
  • Exact 100% purity: Suspicious — real testing always shows slight variation
  • No batch number: Can't trace back to specific production
  • No endotoxin testing: For injectables, this is essential
  • Template looks like it was made in Word: Professional labs have standardized formats

I have seen fake COAs that are literally photoshopped. Always verify independently if possible.

22 17JessicaM_2024, TomFromTexas, mike.trainer_LA and 19 others
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