Compendial perspectives on botanical identity testing

Authors: SARMA, NANDAKUMARA - United States Pharmacopeia; MONAGAS, MARIA - United States Pharmacopeia; GIANCASPRO, GABIREL - United States Pharmacopeia; BRINCKMANN, JOSEF - United States Pharmacopeia; Harnly, James; KABABICK, JAMES - United States Pharmacopeia; JOHNSON, HOLLY - United States Pharmacopeia; PAIS, PILAR - United States Pharmacopeia; GAFNER, STEFAN - United States Pharmacopeia; LU, ZHENGFEI - United States Pharmacopeia; MARLES, ROBIN - United States Pharmacopeia

Submitted to: Journal of Natural Products
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 1/9/2026
Publication Date: 1/20/2026
Citation: Sarma, N., Monagas, M., Giancaspro, G., Brinckmann, J., Harnly, J.M., Kababick, J., Johnson, H., Pais, P., Gafner, S., Lu, Z., Marles, R. 2026. Compendial perspectives on botanical identity testing. Journal of Natural Products. 2(89):339-351. https://doi.org/10.1021/acs.jnatprod.5c01200.
DOI: https://doi.org/10.1021/acs.jnatprod.5c01200

Interpretive Summary: Accurate botanical identification is essential for the health and safety of consumers of botanical supplements. However, the biological complexity and various processing methods of these plant materials presents an analytical challenge. Compendial botanical identification methods provide the first line of defense against misidentification and adulteration. Compendial methods are standardized analytical procedures published in official pharmacopeias and are legally recognized for testing drugs and ensuring quality, safety, and consistency. They comprise orthogonal procedures for morphological and chemical characterization, specifications, acceptance criteria, and consistent nomenclature and labeling. Pharmacopeial standards provide guidance on development of identification and validation of methods for each botanical and matrix. This publication provides a compendial overview on the challenges of developing the methodology necessary to protect the consumer.

Technical Abstract: Quality control systems such as Good Agricultural and Collection Practices, current Good Manufacturing Practices, and regulations emphasize the importance of botanical identity verification for assuring safety and purported benefits. The inherent biological variability and chemical complexity of botanical raw materials, extracts, and fractions demand fit-for-purpose methods for the accurate identification and discrimination from confounding materials and adulterants. Compendial botanical identity testing comprises orthogonal procedures for morphological and chemical characterization; specifications and acceptance criteria versus reference standards; consistent nomenclature; and labeling. Pharmacopeial general chapters provide guidance on the system suitability and method validation tests needed for each matrix to demonstrate specificity and sensitivity.