Testing as a Service

We are not going to facilitate group buys. There is too much legal risk there. Risk is something we have been trying to get away from. That's why we don't offer these compounds ourselves anymore. If I was okay with the risk, I would just put them back up on the site and make it a ton easier for everyone. It's not like I shut down our supply chain when I closed Ceretropic. I still have, or have access to, everything I always had; more even. I just can't sell them to anyone. Facilitating a group buy would be just as much risk as a direct sale.

However, contract analytical testing is something we are working towards. That's why we are trying to get ourselves to the point of ISO-17025 certification. That's a very very difficult process, and most of the labs the other nootropics companies use are not ISO-17025 certified. You would not believe the tracking, processes, and paperwork that goes into actually being ISO-17025. Not to mention the standards being in a different league altogether. I mean, you have to run daily, or in some cases hourly, calibration curves on your machinery using validated reference standards. You have to have IQ/OQ validation for every piece of machinery you use ran by certified technicians. We just did IQ/OQ for our new UPLC and HP-TLC. Between them there are like 1,000 pages, and we need to keep those on file for FDA audits. They ran standardized analytical methods on the machine using known reference standards, and had to show they matched the results expected. This needs to be run every year on every machine. You need to have validated OOS procedures, and run OOS investigations on any result that falls outside of spec. Your methods need to be validated, which can sometimes take 6-8 months of a full-time person working on a single method. Then there are the costs of standards. The reference standards for ashwagandha alone are almost $4,000. We need to use some of each of those standards every single time we run a test, to ensure our calibration curves are correct. This is the only way to be sure your quantitative numbers are accurate. Many labs don't do that. They run a single calibration curve, then just do the math based off that old curve to get QC numbers. Most people have no idea how complex it is to do things the right way. Hell, I didn't know any of this stuff a couple years back, either. Building out an analytical testing lab has taught me a lot.

So things are much much more complex that most people realize, and I never like to do things unless I can do them right. We are working toward being able to do contract analytical testing for other people. However, I will not take on any projects until I am absolutely sure things are perfect. That does not solve all the other logistical issues with group buys, though. Those are not something easily solved. A LOT goes into things like this. I think people have this basic level view of how things go, and just think you order from a lab in China, have it tested, then everything is good. However, it's so much more than that. If you get a sample to test, you also need to test the production batch, since they may have switched it out. This happens all the time. You need to inspect every container of product that comes in, to ensure they did not sneak a different batch in with the larger one. You need to get things through customs and potential FDA holds. You need to ensure you can actually test the compound you are looking to get, and choose the analytical methods that actually give you the results you expect. NMR can only see chemical groupings that contain hydrogen. If there is something in there without a hydrogen, it can't see it. So it might look pure, but you just can see the impurity. FTIR/ATR can only see functional groups containing carbon. If there are no carbon bonds, it can't see it. It also cannot see isomers or enantiomers. HPLC/UPLC can only see things with a chromophore, unless you have something like an ELSD detector, which has its own limitations. Polarimeters can see the difference between D and L enantiomers, but not cis and trans. Raman can see cis and trans, but not D and L. Mass specs can see things with a mass, but it is often hard to separate things from one another to do that. So your methodology is super key, and the difference between having shit data or valid data. So for metals you need ICP/MS. For volatiles you need GC/MS. For larger molecules you need LC/MS. For botanicals that have a lot of similar-structured compound in them, or for proteins, you need a triple quad LC/MS-MS. For larger botanicals and species/plant part ID, you need HP-TLC. For residual solvents or pesticides you need a headspace GC. For all of these, you need validated testing methods and reference standards, and to run calibration curves to ensure the numbers are right. For an ICP/MS that means running a calibration curve with heavy metal standards every hour in some cases. You are using extremely volatile solvents and buffers that you need to properly vent and dispose of. It's an insanely complex process that many people take for granted. What goes on in the background to get these numbers would blow some people's minds.

When I just did free testing for people a few years back, that was a nice way to quickly see if something was either correct or wildly incorrect. However, it was not a valid way to see if things were properly in-spec like a real ISO-17025 lab would do. I did not even know all the limitations of the testing methodologies I was using, nor what to ask of 3rd party labs to see if they were doing things properly. For me to offer testing services to people today, I would be holding us to a much much higher standard than I even knew existed in the past. This is why I am currently not offering that service, till I am sure we are perfect and we are ISO-17025:2017 certified. I will also only offer it on methodologies I know are accurate and validated. This might be frustrating for some, but hopefully I have given a little insight into the complexities of what goes on in the background, and why it is not a simple process.