Natural Products Insider

NOV-DEC 2018

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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70 INSIDER November/December 2018 but not re-verifi ed at the time of sale, after the material may have degraded in storage. Without verifi ed references—the critical factor on which results are based—a test method is a house of cards waiting for the next stiff breeze. 6 What is the analytical range or limit of quantifi cation (LOQ), and how was the range determined? Methods are only applicable within a certain range of concentration. Some of the most sensitive and specifi c methods that go down to parts-per-trillion are useless or require modifi cation at higher concentrations. Likewise, excellent precision and accuracy needs to be demonstrated at the lowest LOQ, which requires that the LOQ was properly determined. 7 What is the expected within-lab variation of the method? This is a/the central metric for method precision, usually in the form of percent of RSD (repeatability standard deviation) for numerical results. Alternatively, this number can be measured as a false rejection or acceptance rate for binary methods like identity or pathogens. The more of a substance there is, the more precise the method should be. 8 Is this method included in the scope of a lab certifi cation? ISO 17025 certifi cation, the most common lab profi ciency certifi cation standard in the United States, is something that many labs hold and promote. What many labs fail to disclose are the specifi c methods under the scope. If a method wasn't in the scope, then it wasn't reviewed and is not certifi ed. 9 Does the test report include the method reference, as well as correct units and signifi cant fi gures, and other relevant information? How are disputed and out-of- specifi cation (OOS) results dealt with? Testing is clear sailing until an unexpected or OOS result emerges. Does the lab automatically re-run samples that are OOS? What are the steps they take in an OOS investigation? A brand must demand transparency from its lab, but it must also share information with the lab. If the brand doesn't provide information on the composition of the sample, expected range of the analyte and, in some cases, how it was processed, then labs must take a leap of faith on selecting or approving the appropriate method. And method validity and reliability abhor leaps of faith. The one takeaway to remember about ensuring valid results: It takes two to make a thing go right. Blake Ebersole has led a number of botanical quality initiatives and formed collaborations with dozens of universities and research centers. As president of NaturPro Scientifi c (naturproscientifi c.com), Ebersole established quality compliance and product development services for supplements and ingredients such as ID Verifi ed™. Follow him on Twitter at @NaturalBlake. Contract Labs

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