Quality specifications for articles of botanical origin from the United States Pharmacopeia

Phytomedicine : International Journal of Phytotherapy and Phytopharmacology
Cuiying MaGabriel Giancaspro

Abstract

In order to define appropriate quality of botanical dietary supplements, botanical drugs, and herbal medicines, the United States Pharmacopeia (USP) and the Herbal Medicines Compendium (HMC) contain science-based quality standards that include multiple interrelated tests to provide a full quality characterization for each article in terms of its identity, purity, and content. To provide a comprehensive description of the pharmacopeial tests and requirements for articles of botanical origin in the aforementioned compendia. Selective chromatographic procedures, such as high-performance liquid chromatography (HPLC) and high-performance thin-layer chromatography (HPTLC), are used as Identification tests in pharmacopeial monographs to detect species substitution or other confounders. HPLC quantitative tests are typically used to determine the content of key constituents, i.e., the total or individual amount of plant secondary metabolites that are considered bioactive constituents or analytical marker compounds. Purity specifications are typically set to limit the content of contaminants such as toxic elements, pesticides, and fungal toxins. Additional requirements highlight the importance of naming, definition, use of reference mate...Continue Reading

Citations

Jul 26, 2018·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Alessandra DurazzoStefania Sette
Dec 29, 2020·Journal of Ethnopharmacology·J A BrinckmannDavid E V Harter
Jun 9, 2020·Phytomedicine : International Journal of Phytotherapy and Phytopharmacology·Xiaoyan WangYan-Xu Chang
Apr 14, 2020·Journal of Natural Products·Nandakumara D SarmaGabriel I Giancaspro
Oct 27, 2021·Journal of Dietary Supplements·Nandakumara SarmaGabriel Giancaspro

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