Endotoxins and Sterility?

[Skydweller007]

So I’ve noticed that most peptide vendors test for purity and volume. But most don’t check for endotoxins and sterility? How often are those a problem?

 

[peptideusername]

How often are those a problem?

Basically never.

I have seen a number of endotoxin tests and none of them have ever come close to the USP/FDA limit of 5 EU/mL for parenteral injections. I'm not saying it's impossible, but I am saying it's fairly improbable.
And sterility testing is almost moot when you consider filtering your peptides. Why waste money on a sterility test when you can just spend that money on filters and sterilize your peps yourself?

 

[bbrewer]

Basically never.

I have seen a number of endotoxin tests and none of them have ever come close to the USP/FDA limit of 5 EU/mL for parenteral injections. I'm not saying it's impossible, but I am saying it's fairly improbable.
And sterility testing is almost moot when you consider filtering your peptides. Why waste money on a sterility test when you can just spend that money on filters and sterilize your peps yourself?

So true, I have never seen an endotoxin test of concern. And just because one vial is sterile, does not mean the others are. I point this out in almost every group testing group I have been in. But then we vote and the majority wants to test for both plus heavy metals. Like clockwork someone says "It's only a little extra per vial to be safe and look how much money you are already saving."

 

[frankpeptid]

Basically never.

I have seen a number of endotoxin tests and none of them have ever come close to the USP/FDA limit of 5 EU/mL for parenteral injections. I'm not saying it's impossible, but I am saying it's fairly improbable.
And sterility testing is almost moot when you consider filtering your peptides. Why waste money on a sterility test when you can just spend that money on filters and sterilize your peps yourself?

I don't think syringe filters are able to sterilize everything

 

[peptideusername]

I don't think syringe filters are able to sterilize everything

Feel free to think whatever you want.
But the pore size of the filters I have are smaller than bacteria so it will physically filter bacteria out of the solution. I'm sure you're technically correct, which is the best kind of correct.

My point remains the same: use the money to filter every vial instead of spending that money on testing only one vial.

 

[Benito Camela]

I saw the whole Jano interview on youtube today; this becomes an issue after 4 weeks of the vial being reconstituted. I would love to see these tests on a vial that has been used weekly for 4-6 months...

 

[BooneDonk]

Feel free to think whatever you want.
But the pore size of the filters I have are smaller than bacteria so it will physically filter bacteria out of the solution. I'm sure you're technically correct, which is the best kind of correct.

My point remains the same: use the money to filter every vial instead of spending that money on testing only one vial.

I second this X1,000! I paid less than the cost of 10 filters than the cost of the one vial of KLOW I donated to test. Results were within margin of error for my recon as it were, but now I know for the other 8 vials. I did YOLO on number 1 to zero regrets. YMMV as I have recently figured out what that means.

 

[randompersonrandom]

YMMV as I have recently figured out what that means.

I will use this going forward when I use a phrase that's new to me.

 

[YoYoFat]

Basically never.

I have seen a number of endotoxin tests and none of them have ever come close to the USP/FDA limit of 5 EU/mL for parenteral injections. I'm not saying it's impossible, but I am saying it's fairly improbable.

Help me understand. I’ve seen 5EU/mL and 10EU/mL as the upper limit.

But the test results come back by as “xEU/vial,” not “xEU/mL.” How do we know the mL used in the testing?

What x would be acceptable when the test reports as xEU/vial?

 

[nevets]

Help me understand. I’ve seen 5EU/mL and 10EU/mL as the upper limit.

But the test results come back by as “xEU/vial,” not “xEU/mL.” How do we know the mL used in the testing?

What x would be acceptable when the test reports as xEU/vial?

Whatever mL you use to reconstitute. If you use 3mL take the test result and divide by 3 to obtain the xEU/mL.

 

[IshimaruKenta]

So true, I have never seen an endotoxin test of concern. And just because one vial is sterile, does not mean the others are. I point this out in almost every group testing group I have been in. But then we vote and the majority wants to test for both plus heavy metals. Like clockwork someone says "It's only a little extra per vial to be safe and look how much money you are already saving."

And to the opposite, just because one vial failed sterility does not mean that the other vials will too, or that the entire batch is. You'll also see that no vendor guarantees sterility at all. If that matters to you (in general), filter, or choose big pharma. 🤷‍♂️