Partner Series—Application of FTIR and NIR to Meeting the 100% Identity Requirement for Dietary Supplements: Which Technique is the Right Choice

INSIDER Partner Series

Today’s dietary supplement industry has become highly regulated and one of the most common FDA warning letter points is that companies had failed to establish a scientifically valid identity technique.  To meet the high throughput demands of today’s supplement manufacturers, many companies have turned to the use of FTIR (MIR) and NIR spectroscopy.  While both of these techniques are very powerful and effective for identity, there have been significant issues with the way that the techniques have been implemented.  This webinar will build upon the prior webinars by helping companies determine when to select FTIR (MIR) and when to select NIR.  Further, guidelines for approaching the development and validation of methods using molecular spectroscopy will be discussed.  Attendees will gain valuable insight into application of these techniques and will be able to better develop and implement valid identity methods.   Historical use of NIR in the DS industry was mostly flawed due to a lack of understanding about the way to gather and utilize data.  Properly developed and validated, the techniques are very robust and defendable as quality identity methods.  Application of the new AOAC POI Validation Criteria for Botanical Identity Methods and how they apply to FTIR and NIR will be discussed as well.

Learn about:

• How to decide if FTIR or NIR is the proper technique to use for identity testing
• What you need to do to assure your methods will be scientifically valid and withstand FDA review
• Why companies have had historical problems with NIR and how to avoid these common pitfalls
• How the new AOAC POI Botanical Identity Validation Guidelines apply to molecular spectroscopy methods
• Avoiding common mistakes made in the industry and how to succeed with FTIR and NIR

Speaker:

James Neal-Kababick is the founder and director of Flora Research Laboratories and serves on numerous regulatory agency, AOAC and trade association committees focused on dietary supplement.  He was the founding Chair of the Methods Committee on Dietary Supplements for AOAC and was named Fellow of AOAC for outstanding contributions to his field of science and service to the organization; AOAC’s second highest honor bestowed to scientists.  James  pioneered the field of Phytoforensic Science which is the application of analytical techniques from microscopy to mass spectroscopy to detect adulteration in the global food supply chain.  He’s and adjunct professor at Bastyr University where he teaches botanical.  For almost 20 years, James has developed  and implementing analytical solutions for the Nutraceutical industry.  He is a collaborative research partner with some of the world’s largest scientific instrument companies helping them advance their technologies to meet the needs of the dietary supplement industry.




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