Confirmed: AmoPure does not guarantee sterility

[iamedbile]

After the 30mg and 60mg tirzepatide from AmoPure (aka L30 and L60) both failed peptidetest.com's USP<71> style sterility testing I reached out to Alan at AmoPure.

He has confirmed that AmoPure currently does no in-house sterility testing and does not guarantee the sterility of their products. (See image)

They apparently hope to start doing sterility testing in house at some point in the future and may offer a sterility guarantee at that point, but for the foreseeable future AmoPure products should be assumed non-sterile and treated accordingly.

Personally, I will be filtering mine with a 0.22pm syringe filter.

30mg USP <71> style sterility failure: https://coa.trustpointeanalytics.com/?testRef=N5FAV9VYVU29
60mg USP <71> style sterility failure: https://coa.trustpointeanalytics.com/?testRef=M18HKKPGFXMG

 

[astroman]

Man, just about the time I was going to make my first order with them…

 

[geoguy78]

Do any vendors guarantee sterility? There have been a large number of sterility tests conducted recently of multiple vendors, and it looks like pretty much everyone has failed. I just don't see how gray market peptides could possibly be sterile, you would need to control the entire production chain from creating the raws, to lyophilization, to filling vials. I'd be concerned if there had been reports of injection site infections online, but there haven't been any. Personally, I think there's been a recent "mass hysteria" about peptide sterility and everyone went out and spent a ton of money on testing, and now we're seeing that none is sterile. FDA approved drugs through legal sources via prescription is the only way to ensure that you're 1-getting just the peptide you want (testing doesn't tell you what else is in that vial...), and 2-getting a sterile product.

 

[astroman]

Do any vendors guarantee sterility? There have been a large number of sterility tests conducted recently of multiple vendors, and it looks like pretty much everyone has failed. I just don't see how gray market peptides could possibly be sterile, you would need to control the entire production chain from creating the raws, to lyophilization, to filling vials. I'd be concerned if there had been reports of injection site infections online, but there haven't been any. Personally, I think there's been a recent "mass hysteria" about peptide sterility and everyone went out and spent a ton of money on testing, and now we're seeing that none is sterile. FDA approved drugs through legal sources via prescription is the only way to ensure that you're 1-getting just the peptide you want (testing doesn't tell you what else is in that vial...), and 2-getting a sterile product.

I’m a gambling man.

 

[Tomes]

Do any vendors guarantee sterility? There have been a large number of sterility tests conducted recently of multiple vendors, and it looks like pretty much everyone has failed. I just don't see how gray market peptides could possibly be sterile, you would need to control the entire production chain from creating the raws, to lyophilization, to filling vials. I'd be concerned if there had been reports of injection site infections online, but there haven't been any. Personally, I think there's been a recent "mass hysteria" about peptide sterility and everyone went out and spent a ton of money on testing, and now we're seeing that none is sterile. FDA approved drugs through legal sources via prescription is the only way to ensure that you're 1-getting just the peptide you want (testing doesn't tell you what else is in that vial...), and 2-getting a sterile product.

It's correct that none of these products is sterile, which must meet very specific criteria. The "sterility" tests are bacteria, mold, and yeast tests for non-sterile products (TAMC/TYMC). The USP(71) "sterility" test is a more comprehensive test but mis-named as it is not a true USP(71), which again has very specific standards.

Though there have been fails across vendors recently (which maybe came from the same contaminated raws) plenty of other tests have been "Pass." It's everyone's choice who to buy from. For me these tests provide an indicator on who is most careful with their end to end supply chain and manufacturing process. There are a lot of vendor choices out there, so I'd rather go with the ones that are the absolute best in terms of standards and test results.

 

[iamedbile]

There have been a large number of sterility tests conducted recently of multiple vendors, and it looks like pretty much everyone has failed.

I doubted this, so I went digging in a testing archive I had access to. Here's what I found:

• 22 total tests for microbial contamination (what we sometimes call "sterility")
• 14 fails
• 8 passes
• No supplier had more than one pass

I was not able to find any grey market suppliers that have a proven track record of sterility given the limited data currently available. While there have been a handful of passes I think @geoguy78's statement is generally accurate.

 

[iamedbile]

I am not, by the way, trying to beat up on AmoPure. I am certainly not trying to tell anyone who to buy from or not buy from. I'm providing information from a vendor in response to some recent testing data so that others can use it to make informed choices.

Personally, I will be filtering this product and using it in my research as planned.