Hi! New here with many questions about testing

[vond4]

Hello all. RS is dealing with several health challenges and a limited budget, and so I'm drawn to bulk suppliers, but I'm concerned that the only testing I see is for purity via HPLC and there's no testing for residual solvents.

Some of the solvents used in the solid-phase peptide synthesis are extremely, extremely toxic even in small amounts (which is why the standards for research and pharmaceutical grade are different), and I'd want to make reasonably sure that anything RS came into contact with regularly wasn't going to give RS a new, entirely different health challenge. (RS accepts the risks of the substances themselves; it's the surprise contaminants I'm concerned about.)

As far as I can tell Janoshik only offers purity testing via HPLC (residual solvent testing would require gas chromatography)., though I have reached out to ask about other testing I've also reached out to QSC to find out about the results of their own residual solvent testing, but haven't heard back yet.

Does anyone know of a third party service that will provide residual solvent testing for an individual (not an accredited company or university etc)? Has anyone managed to get this done?

 

[vond4]

I figure I will update whatever I find here...

So far Jano has confirmed that they DO offer GCMS testing for harmful contaminants, but QSC merely supplied links to HPLC purity testing. I've clarified my request to QSC in case there was a misunderstanding.

I've also followed up with Jano with a few clarifying questions about available GCMS tests, but I'm actually very concerned that I can't find any publicly available GCMS residual solvent testing results. ETA: I've asked Jano how many GCMS they've done without asking about any specific vendor, just to get an idea of whether anyone is doing this testing at all.

I intend to get this testing done, but is anyone aware of any vendor that discloses the results of GCMS testing? It's wild to me that I can't find any public results...

 

[Bacchus]

It’s a bit more complicated than it looks. Many sellers who offer international shipping and delivery guarantees aren’t actual labs—they’re resellers with a good setup for handling customs.

Labs that produce these products often focus on production and may not always provide detailed testing information, especially if they aren’t set up for consumer-level testing. Resellers might source from various labs or other resellers, so they don’t always have comprehensive data on formulation ingredients, synthesis impurities, or excipient impurities.

Additionally, resellers basically can't invest in extensive testing because it can be very expensive—around $5,500 to $14,000 for a full set of tests. If you have multiple products from multiple sources, that’s a significant investment. This cost would also be more or less the same for the lab if they test every batch, which is part of the reason why the brand name is a lot more expensive.

The best you can hope for, while getting the prices you are from China is to find a seller that has: Formulation Ingredients, Peptide Synthesis Impurities, Excipient Impurities and Safety Profile of Impurities. Having that makes it much more likely that a product is safe.

But with the prices you expect from China, you will (probably) not find any batch for sale that has had these tests done.

Edit:
The concerns you have are most likely unwarranted though, as the raws the various labs use comes from a few sources.

 

[nurseratchit]

Mos

I figure I will update whatever I find here...

So far Jano has confirmed that they DO offer GCMS testing for harmful contaminants, but QSC merely supplied links to HPLC purity testing. I've clarified my request to QSC in case there was a misunderstanding.

I've also followed up with Jano with a few clarifying questions about available GCMS tests, but I'm actually very concerned that I can't find any publicly available GCMS residual solvent testing results. ETA: I've asked Jano how many GCMS they've done without asking about any specific vendor, just to get an idea of whether anyone is doing this testing at all.

I intend to get this testing done, but is anyone aware of any vendor that discloses the results of GCMS testing? It's wild to me that I can't find any public results...

Most of these contaminants should evaporate during the lyophilization process but trace amounts may remain if not thoroughly done. I don’t think you’re going to find any 100% guarantees in the gray market and you’re definitely not going to get any straight answers from Tracy at QSC.

 

[Broken Chef]

Welcome!

Sterility testing is currently being discussed on several platforms.

From what I understand, a USP 71 sterility test that utilizes an entire kit (10vials) is the best option available. I'm not a chemist and don't really understand all of this, but..

As another person said, it's not been an issue. We see the occasional ISR noted, but I've not heard of people coming down with new health issues from contaminants. There's the obvious side effects and risks that go along with any substance.

If you are concerned, the best bet is to use a .22 micron syringe filter after reconstituting and put that directly into an empty sterile vial. It's my understanding that won't remove endotoxins or viruses, but as I said, those aren't something we see as an issue. Most people don't even use the filter and are not having any problems... That's not to say it couldn't happen, and I understand your concerns.

QSC probably isn't your best bet for these concerns. They are more of a "buy from me or piss off" kind of vendor and I doubt you're going to get them to engage in meaningful discussion about sterility. They are high volume and they just don't seem to care about anything except getting your money and moving on to the next buyer... Not to say the others don't have $$ as top priority.

There are MANY other vendors, including people who organize group buys and have worked with trusted vendors for years. Referred to as "gb". A gb GENERALLY (but not always) comes with: shipping fees included, batches made to order, and 3 vial testing for purity and fill. Some gb facilitators will set up sterility testing for the buyers who are interested. Those interested then split the cost. It's about $250 for the USP 71 Sterility test, plus the cost of a kit (10 vials). There are other tests, which are additional costs, but this is not generally done as it's not proven to be an issue. The vendors have no reason to add contaminants. They want to build a good rep and continue selling, not hurt people and go out of business. I do think your concerns are a bit needlessly excessive, but you are certainly welcome to spend $1000+ testing $300 worth of product... But then the other kit that you'd use from, could be the one with bacteria, so even with all that testing, there is still no 100% guarantee the vials you use are as sterile as the ones you tested.

This is a grey market, not pharmaceutical companies in the US. If you are that concerned, I'm afraid buying brand name products from a US pharmacy might be your only option.

 

[Sheldor]

hello.

You can reach out to https://analizabialek.com/services/
They are located in Poland but are speaking English as well. Ask them, maybe they can help you