Abstract |
The United States Food and Drug Administration (FDA) is responsible for monitoring the safety and efficacy of pharmaceuticals, food supply, cosmetics, as well as other biological products. While the production of manmade drugs is strictly governed by FDA regulations, dietary supplements, including homeopathic remedies, are not subject to the same rigorous rules and guidelines because they are classified as foods, not drugs. As a result, supplement companies are tasked with developing tools and methods for evaluating the identity and safety of their products, with little guidance from the US FDA or US Pharmacopeia for how to screen materials. In the present study, we demonstrate the use of direct, high-resolution mass spectrometry approaches to screen raw materials to be used in natural, dietary supplements. Specifically, the Direct Analysis in Real Time (DART) ionization source is used to directly desorb and ionize molecules from raw materials. A high-resolution Orbitrap mass spectrometer is used to separate and detect ions based on the mass-to-charge ratios. Key chemical components in these raw materials were identified with this approach and used to classify/grade these bulk natural products. Many compounds have been detected in these materials including curcumin and tumerone in Turmeric. Finally, the applicability of this approach to detect and identify adulterants in the materials, including pesticides and herbicides, will also be presented.
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