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Chromadex Creatine Ethyl Ester Certificate Of Analysis Interview



Posted in: Research Articles, Supplement Articles, Creatine | Feb 21, 2007



Interview with Frank Jaksch, President, CEO & cofounder of ChromaDex Research has always been the backbone of our philosophy. We're dedicated to developing the most effective supplements in the world. That's why we have always had a progressive product research and development philosophy. We stand behind our commitment to science. That's why each one of our supplements undergoes our quality-control process, which ensures that the product you buy is of the highest standard. It is important to trust only reputable manufacturers like MuscleTech to supply you with quality nutritional supplements. In manufacturing our products, we use only the highest quality ingredients and use independent laboratory analysis to confirm the potency of the ingredients listed on our labels.
Question: What are the testing procedures ChromaDex employs for creatine ethyl ester? (a) what lab analysts are looking for (b) machines, chemicals, or other apparatuses used (c) length of time the process takes
Frank Jaksch: I'll break the answer up into pieces. The method that we use for creatine ethyl ester is an HPLC [high-performance liquid chromatography] method. Also, on top of that, we specifically use ultraviolet (UV) detection for doing the determination. In terms of how much time this takes, we're pretty detailed in what we do, and an average single test in running HPLC usually takes 20 to 30 minutes or more. But we usually run things in triplicate. We run other standards and blanks and such, so a single sample can actually take upward of anywhere from four to eight hours.
Question: So what exactly are you looking for when you receive a sample of creatine ethyl ester (CEE)? Are you checking for purity and things like that?
Frank Jaksch: Typically, we're checking for purity. It depends on the nature of the sample. Sometimes we receive raw material samples, and sometimes we receive finished dosage form samples. So the goal may be slightly different. In the case of a raw material, if we received creatine ethyl ester HCL raw material, we'd be trying to report a percent purity. If it were a capsule or a tablet, we would be most likely reporting it in milligrams per serving.
Question: When you test CEE-Pro, do you test one bottle? Three bottles? How does it work?
Frank Jaksch: That's largely up to Iovate's sampling procedures. We test whatever samples are sent, typically by lot number or by sample identification. So if Iovate sends us three samples that were three different lot numbers, we would report individual results for all three. If you just sent a single sample, we would report just the single sample.
Question: Are the results then averaged for all three samples?
Frank Jaksch: No, they wouldn't be averaged. If they were three separate lots, they wouldn't be averaged. But we do run averages. We will prepare the same sample three times and then do averages. So when we receive it, for instance, the first thing we're going to do if it's a capsule is that we would check the "fill weight." So we would take 10 or 20 capsules, empty them, and check to see the fill was accurate. And then we would take an average weight, and then we would go into sample preparation, preparing that sample. And then typically we're going to prepare the sample three times, do three independent injections, and then average those numbers for a single sample.
Question: Is this method that you use to test creatine ethyl ester unique to your company, or do other companies have this sort of process?
Frank Jaksch: It has been relatively unique to us. There's not very many other contract labs that have a creatine ethyl ester test method. I'm sure that there are a couple of other labs now that are probably starting to do this analysis. But we were one of the first ones. I think we were the first one that was offering analytical testing for CEE.
Question: Could you hazard a guess as to how many labs in North America test for CEE?
Frank Jaksch: It can't be more than two or three.
Question: Obviously this demand for testing might go higher as the popularity of CEE picks up, right?
Frank Jaksch: It could, yeah. The one thing about that, though, is that testing for CEE is not easy to do, which is why I guess we got involved with it from the beginning. CEE is obviously a creatine-related compound, and testing creatine-related compounds is not easy to do. The problem centers around creatine and creatine-related compounds in general. They don't retain very well in an HPLC system.
Question: What does that mean?
Frank Jaksch: That means that -- in analytical chemistry terminology -- if you can't get a compound to retain very well, then it's difficult to separate it out from other potential impurities. This means it makes it very difficult for people to report a true purity.
Question: I guess you've found a way to work around that.
Frank Jaksch: We have been able to develop a method that, in the case of CEE, retains creatine ethyl ester extremely well.
Question: Is there a name for this process?
Frank Jaksch: I wouldn't say that there's necessarily a name for that. It's the same process that we defined at the beginning, in that we are using an HPLC system. Like anything, it can be programmed. There's a million different variables that can be modified to change the parameters that you are testing for.
Question: What are some of the typical impurities that you would find in creatine ethyl ester?
Frank Jaksch: From what we've seen so far, you can see creatine itself [creatine monohydrate without an ethyl ester bond], potentially, or creatinine [a waste product of creatine].
Question: Which of the two are you more likely to find?
Frank Jaksch: Creatinine has seemed to be the most common impurity.
Question: Are there any special machines or apparatuses that you use during testing?
Frank Jaksch: During the initial process when we started looking at CEE, we were actually using HPLC with mass spec detection. Mass spec, unfortunately, doesn't make a good quality control tool. It's a fairly sophisticated piece of equipment, and it's usually used for research. We have full analytical capability, including several different forms of mass spec. But at the beginning we did use mass spec as a tool to solve the analytical problem with CEE.
Question: Do you still use this mass spec detection method?
Frank Jaksch: Not with the current method. The method now just uses the UV detection method.
Question: How does the UV method work?
Frank Jaksch: Right now, we're just using a single wavelength of UV to determine creatine ethyl ester. You don't need to get any more sophisticated than that. Typically, just a single fixed wavelength works fine.
Question: What do you see for the future of CEE testing?
Frank Jaksch: Moving into the future, there's going to be a lot of confusion out there regarding CEE. It's no different than many other dietary supplements on the market. There's different labs, and different companies are going to use different test methods. We've already seen these problems on a day-to-day basis. There are companies that we report a purity to, and it's lower than what they were expecting to see. We show our data, and then we get into an argument where they'll go back to their raw material or contract manufacturer, and the manufacturer will say, "Oh, we tested it," but they used a different method from our method. And I'm sure you guys have heard all that before. But when we go back and start evaluating the problems, the other companies are generally using inappropriate methods to perform determination of these compounds. We're pretty particular about doing testing the right way, and follow proper protocols. And since our core business is in the reference standard side of things, we have to understand analytical methods. Analytical methods very important to the industry. In the United States and internationally, there's a huge push toward standardizing analytical methods for dietary supplements.
Question: Do you foresee the day when we have standardized methods of testing for dietary supplements?
Frank Jaksch: It's a long ways away, because everybody argues over what is in fact going to be the appropriate method. It will solve itself relatively quickly once it really starts to move. But the momentum will not start for several years, though. "The tests that we have done for CEE-Pro, both of them have been well within the specifications that they were supposed to be, in terms of the creatine ethyl ester content [in CEE-Pro] in the caplets that were tested."
Question: Are you confident that ChromaDex is using the finest methods in the industry to test for CEE, such that you set the industry standard?
Frank Jaksch: We're very confident in the ability of our method right now. We're very confident with it. CEE methods started with somebody just approaching us, saying "We need a reference standard developed for this." And that's all we were approached with: "Can we develop a reference standard?" The answer was, "Yeah, we can." And back in December [2004], we developed the CEE reference standard.
Question: Do you test any other companies for CEE?
Frank Jaksch: Yeah, we do testing across the board.
Question: How did the MuscleTech supplement CEE-Pro rate, according to your testing methods?
Frank Jaksch: The tests that we have done for CEE-Pro, both of them have been well within the specifications that they were supposed to be, in terms of the creatine ethyl ester content [in CEE-Pro] in the caplets that were tested.
Question: So did CEE-Pro fall within acceptable parameters every time, basically? [Note: Iovate's acceptable range for CEE-Pro, for creatine ethyl ester, is 90 to 120 per cent of the label claim.]
Frank Jaksch: From the testing we've done, anywhere from about 94 or 95 percent to 103 percent.
Question: Do you find some other companies are testing and getting incredibly low or poor results?
Frank Jaksch: We've found products [from other companies] that have been low. We found some that are so low that there really isn't any [CEE] there! [laughs]
Question: Really? So almost zero?
Frank Jaksch: Well they've obviously received the wrong raw materials. Somebody was representing the wrong raw material as CEE. And that's happened on a couple occasions. We've found products [from other companies] that have been low. We found some that are so low that there really isn't any [CEE] there! [laughs]
Question: Anything else you'd like to add, Frank?
Frank Jaksch: Just that to finish off, with the type of analytical test methods that are used, companies do have to discriminate very much and scrutinize the contract testing labs that they use, and the types of methods that they're using to differentiate. Because HPLC methods can be used against you, meaning that if you accept at face value what somebody else is reporting, they may be using a test method to hide something. And we've seen these issues before, and I think CEE will hopefully come clear very soon. And there still are some very challenging analytical methods out there.




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