Authentication quantitation and detection of adulteration in botanical dietary supplements using an automated chemometric platform

Abstract The objective of this SBIR Phase I proposal is to test the feasibility for development of an automated platform that can perform the followingIdentify botanical components of dietary supplements throughout the supply chain by use of chemicalanalysis and integrated pattern recognition softwareDetect the presence of adulteration by use of HPLCand UHPLCanalysis of bioactive compounds andby use of orthogonal data from other analytical instrumentse gterpene analysis by GCAutomate the quantification of the key bioactive compoundsInnovative aspects of the proposed research are the restructuring of proven MIDI Incsoftware for HPLC analysis of bioactive components of botanical dietary supplements and use of orthogonal GC data from metabolitessuch as terpenesThe MIDI software has been cited in more thanpublications and both the HPLC and GC microbiology systems have FDAkclearance as medical devices for species level identificationThusthe basic system is shown to be scientifically valid but needs modification and additions to target botanical dietary supplementsproposed MIDI platformBotanical reference materialsBRMswill be analyzed and the patterns stored electronicallyreducing the need for these expensive materialsChemical analysis patterns of materials throughout the dietary supplement supply chain will also be electronically stored to enable changes due to processing and authentication in all steps of manufacturingThe proposed technology should improve precision of compound naminglower labor costsreduce human errorsimprove turn around time for analysisas well as meeting the objectives aboveHoweverthe keys to success are that it should improve human health due to improvements in quality control of botanical dietary supplementsmake it possible for the industry to largely self regulate and aid the FDA in regulation of the industryThe result should improve human health though removal of adulterated or low quality products from the market Narrative In a recent Council for Responsible NutritionCRNsurveyof Americans take dietary supplementsand while most are safe and may be usefulsome are low quality and others are adulteratedThis SBIR proposal will test the feasibility of development of an innovative platform for species level authentication of botanical dietary supplementsdetection of adulterationand quantitation of bioactive compoundsThe software platform will be fully automatedgive precision chemical analysis and be the basis for industry standards aimed at improving human health