Current initiatives for the validation of analytical methods for botanicals

•The path from single laboratory validation to Official Method status is described.•Common sources of reference material and their roles in validation are described.•Performance characteristics are the deciphering factors in determining a method's suitability.•Chemometrics and design of experiment are used for efficient method development.•Fast analytical methods with efficient use of materials are industry priorities. The demand for validated analytical methods for botanicals has grown in response to the increasing consumer market for botanical supplements. Government initiatives to increase the availability of validated analytical methods and botanical reference material have led to the publication of numerous validation studies in scientific journals. Single laboratory validation and collaborative validation studies are structured to confirm a method's ruggedness and fit for purpose. The performance characteristics and statistical protocols followed throughout a validation study vary with the source of guidelines. Analytical techniques and priority methods are influenced by the need for fast-screening techniques, the limited availability of reference material, market value, and the prevalence of contaminants in botanical supplements.