Readalots Enhanced Testing

It’s asked in every source thread that I’ve seen.

1.HPLC purity (done)

2.GCMS organic/structural impurities (seldomly done, customer driven so far)

3.Metals (TBD)

4. Sterility (a must)

5. Endotoxins (no reason not to have this data)

6. GCMS residual solvents (TBD)

So we should stick to only #1 otherwise the vendors will weaponize #4 on each other and no point in any vendor collected data? Am I following?

Is that your conclusion?

Why don't the vendors weaponize the HPLC testing? 120 usd price point too much for the shills? Simple to do but customer samples wouldn't back up the result.
 
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Why don't the vendors weaponize the HPLC testing? Simple to do but customer samples wouldn't back up the result.
You answered your own question regarding the HPLC. That was figured out a long time ago on this forum.

For sterility, you can have anywhere across the batch contaminated. How would this be verified? Oh, that’s right, “blind” samples. I can’t imagine that being used nefariously.

You need to think this thru better. You ran into a burning building convinced that you would be received as a hero.
 
You ran into a burning building convinced that you would be received as a hero.
Definitely right on the first part. Nah, I didn't think I would make any friends really. Hero? Lol.

Give me your suggested list or let's iterate if you are interested. Your hypothesis this is all impossible with the criminal enterprise in play may be very accurate. Thanks for your thoughts.

Interesting as the next improvement Millard has suggested for testing is sterility.
 
Earlier version here:

Every Source should provide with each shipment ...

1. 3rd party C of A on finished product batch specific to that shipment
- endotoxin screen
- metals with ICP
- purity(ies) / concentration(s) using hplc plus ms (or gcms)

2. C of A for bulk api for each batch (hplc plus ms or gcms) upon request.

Of course Sources would do themselves a big favor if they screened for impurities as well as purity on the APIs (aka raws) upfront so no surprises on the finished batches. First things first

I added the sterility to the list after it was offered by trusted lab and based on harm reduction message here at Meso. @BigNoOne your recommendation is to remove sterility? The others would be harder to exploit.

What's your list?
 
Earlier version here:



I added the sterility to the list after it was offered by trusted lab and based on harm reduction message here at Meso. @BigNoOne your recommendation is to remove sterility? The others would be harder to exploit.

What's your list?
I hope you’re not asking me just to argue. I’ve been clear: find something that is shown to be an actual concern and you’ll get support for the testing of it.

Right now, HPLC is the only test that has any value.
 
Right now, HPLC is the only test that has any value.
Thanks for your comments. No I am not trying to argue for the sake of argument.

To clarify:

1. So you support mandatory HPLC on raws and finished products?

2. You support improving the standard to push for HPLC testing all raws before they go into finished products?

3. GCMS on all raws?

4. To address subvisible / visible (floaters) particles you recommend customers use at the least a spike vial adapter with 5 um filter?

5. Sterility: 0.2 um filtration of all finished oils by the customer? Move the sterility onus onto the customer?

6. You think asking the vendors to do endotoxin testing is useless? Hence, up to customers to blind test for surveillance if they are to find something?

7. Metals a non-issue for finished oils? A simple buyer beware on ugl oral AAS products that aren't filtered? [I would tend to agree]

8. Residual solvents: forget about it at this point? Uphill battle on suitable lab.
 
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Thanks for your comments. No I am not trying to argue for the sake of argument.

To clarify:

1. So you support mandatory HPLC on raws and finished products?

2. You support improving the standard to push for HPLC testing all raws before they go into finished products?

3. GCMS on all raws?

4. To address subvisible / visible (floaters) particles you recommend customers use at the least a spike vial adapter with 5 um filter?

5. Sterility: 0.2 um filtration of all finished oils by the customer? Move the sterility onus onto the customer?

6. You think asking the vendors to do endotoxin testing is useless? Hence, up to customers to blind test for surveillance if they are to find something?

7. Metals a non-issue for finished oils? A simple buyer beware on ugl oral AAS products that aren't filtered? [I would tend to agree]

8. Residual solvents: forget about it at this point? Uphill battle on suitable lab.
I didn’t say any of that.

We are ALL big boys that can do our own things.

I support free market

I support clean, well made, accurately dosed products at a fair price.

I don’t support any interference in the way this is done.

FIND SOMETHING I SHOULD BE CONCERNED WITH and I will support the testing of that. Anything else is a waste of time, effort, and resources.
 
??

You are sounding like QSC now. How does one measure clean?

Please provide your comments on each point above.

You don't support vendors testing raws?


Thank you.
Look. I’m getting increasingly tired of this. You keep raising this concern with NO PLAN.

1,000 vials made

What is “representative” sample size to demonstrate the shit is clean enough to put your mind at ease.

I’m not arguing this with you. Absent third party inspection and sampling, there is no way a source will be able to demonstrate the entire product line is clean.

Think it through more next time.

Any customer that wants to cough up $250+ for a sterility test can. Of course that doesn’t mean the next vial is sterile.
 
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