A Perspective on Additional Approaches Beyond Organic Marker Compounds While Developing Analytical Monographs for Botanicals

Most of the Pharmacopoeia and other monographs that provide the quality specifications for botanicals typically contain identification and physicochemical tests, assays, and limits for contaminants. The assay methods generally involve quantitative determination of known organic compounds, commonly known as markers. The authors explore and propose that there is a need for additional approaches beyond markers, especially for botanicals derived from traditional knowledge and use. Preliminary data on few selected botanicals are additionally provided to communicate the thought process.