Lab Testing following US FDA Requirements for Potency & Purity of Consumer Injectables • Accuracy Matters. Results You Can Trust.TrustPointeAnalytics.com Dorr, MIJoined November 2024
@brandon_collup@ogsvg Sterility, yes. As long as you use 0.22um filters and good technique (don’t contaminate while trying to filter).
No for heavy metals and endotoxin. Molecules are too small, will slip right through.
If the peak elutes at 0.5min in your lab’s COA, you aren’t getting an accurate purity or assay value
This is also why HPLC methods should be developed specifically for each peptide rather than a general screening gradient
@joejfamous@Chris_8086 Have to price in risk and risk to spend a couple years in lockup is priced pretty high
Or maybe this is just a case of “pigs get fat, hogs get slaughtered”
@TrustPointe You can see posts about it on reddit.
They would buy the raw powder and then just weigh it into the vials.
No Lypholization, no sterilization and no vacuum sealing.
Hence the term, bathtub boys.
I wouldn’t say it’s useless
In risk management, it’s always Severity of the issue * Occurrence of the issue.
Let’s assume for this example that Sterility, Endo, and Heavy Metals are all an 8/10 Severity. You won’t die, but worst case - the outcome would be unpleasant.
The likelihood that poor aseptic manufacturing causes nonsterile product is pretty high. Lots of touch-points, raws & processes that can fail, etc. We would give that an Occurrence of 6/10.
The likelihood that the raws had gram negative bacteria in them is somewhat probable as well. Bacteria are everywhere. I would say it’s less possible than accidentally introducing live microorganisms to product, so let’s say Occurrence 4/10.
The probability that these raw materials contain heavy metals is low. Peptide + sugar + filtered water. These aren’t materials known to be contaminated with heavy metals, and most people aren’t processing on equipment containing heavy metals. Occurrence 2/10.
Now assume you can only pay for one test, and look at the risk profiles:
Sterility 8*6 = 48
Endotoxin 8*4 = 32
Heavy Metals 8*2 = 16
Sterility represents 3x the risk of heavy metals.
If you have the money to do all the testing, by all means go for it. But clearly some tests cover more ground than others based on risk analysis.
@ogsvg If people want to know, we’ll offer it 🤷🏻♂️😂
In the hierarchy of things I would personally consider most to least important:
Identity, Potency, Purity
Sterility
Heavy Metals
Endotoxin
@DailyPeptide How is it self-reported?
Any reputable vendor is using third party labs. You can check the lab’s website or call the lab and verify the COA is correct.
@TrustPointe@mannyjplays@GAminos84609 The other day someone showed me a COA(not from Kovera) for metals, said it only cost $50. Didnt list method on the COA, turned out the lab used test strips made for well water. Was not surprised that the result was non detect. Big difference between Atomic Absorbance, ICP-OES,
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