ERP Proposal SPDS Set 2

AOAC Expert Review Panel for AOAC Stakeholder Panel on Dietary Supplements (SPDS) Set 2 Ingredients Summaries of Expertise

BALASURAMANIAN, MURALI Area of Expertise: Quality assessment of Indian Botanicals

I have total experience of over 29 years in the field of Testing Similar experience in chromatograpic techniques. I have been associated with Natural Remedies (Herbal product manufacturing organisation) for about 19 years, where we test the quality of botanicals extracts and their formulations. In the past 19 years my laboratory personnel have tested over 1500 batches Ashwagandha roots and its extracts. We are the leaders in commercially introduce chromatographic methods for evaluation of quality. Developed and validated over 50 chromatographic methods including that of Ashwagandha. Submitted about 100 monographs to IP (Indian Pharmacopoeia) Ayurvedic Pharmacopoeia of India and USP. Analytical method validation for Assay and identity of most of the monographs of Indian medicinal plants (about 12 plants approximately 40 monographs) in USP is provided by us. We have expertise in testing Identity ,Assay, Heavy metals solvent residue Mycotoxins and Pesticides residues. Natural Remedies also supply the Phytochemical reference substance of many Indian botanicals including Ashwagandha. BHATT, PREMAL Area of Expertise: Varied Premal is an Associate Scientific Liaison for the Food Program Unit at US Pharmacopeial Convention (USP) since 2011. Previously, he worked as a Scientist II for USP’s R&D Laboratory from 2005 to 2011. As a Scientific Liaison-Foods, Premal is engaged in developing standards for identity, purity, and authenticity of food components. One of the areas of Premal’s interest is developing such standards for various spices. Premal has a background in analytical chemistry with more than 25 years of experience in various laboratory settings, such as pharmaceutical, chemical, and waste management. Premal holds two Master of Science degrees in Plant Pathology; one from Kansas State University and one from Gujarat Agricultural University, Anand, India. Premal has authored ten research papers in peer-reviewed journals. My laboratory background is in method development: I have been engaged in chromatographic and spectroscopic method development for about 12 years, of which roughly 3 years in generic pharma (LC, GC, titrimetry, IR) and the rest – working for a dietary supplement manufacturer (LC, UPLC, IC, GC, GC-MS, SEC, ICP-OES, NIR, IR, KF, ISE, dissolution). I also spent about 13 years at NIH performing separations of biologically-derived compounds, extracting analytes of interest from physiological fluids, setting up and optimizing bioassays such as ELISA. The largest segment of my time was spent on analysis of dietary supplement ingredients and finished products, both of botanical and non- botanical origin. I have worked to develop the current iteration of chondroitin CPC titration (as published in USP), developed and validated methods for MSM and oil-soluble vitamins, developed and optimized a fast Omega-3 marine oils analysis (poster at AOAC 2011), re-optimized peroxide, acid and anisidine value analyses; I was the AOCS approved chemist in AOCS/GOED Nutraceutical Oils in 2011. I also established in-house metals analysis by ICP-OES, and built incoming raw materials NIR library. Of the botanical analytes, I have hands-on experience with milk thistle, curcuminoids/turmeric, green tea extract, cranberry extract and a suite of methods for cruciferous analytes. The above list is not exhaustive. FULL CV: http://www.jotform.com/uploads/christopherdent/51735966869173/320777138031109893/resume (1).pdf FULL CV: http://www.jotform.com/uploads/christopherdent/51735966869173/320733235947214614/P. Bhatt.Resume.pdf BZHELYANSKY, ANTON Area of Expertise: Methodologies in Dietary Supplements

I have provided analytical support to finished dosage formulators, and actively participated in formulation,