Compendial Perspectives on Botanical Identity Testing

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.