Fan Wu, Richard Creekmore, Chris Moreton, Brian Carlin, Galina Holloway, Hong Wang, Catherine Sheehan

Correspondence should be addressed to: Galina Holloway, Senior Principal Scientist, Science-Excipients, US Pharmacopeia, Rockville, MD 20852-1790; email: gvh@usp.org.

In this Stimuli article, the Excipient Composition and Impurities Joint Subcommittee (JS) proposes new definitions of excipient components and describes rationale for the changes from the original definitions presented in the first Stimuli article “The Complexity of Setting Compendial Specifications for Excipient Composition and Impurities”. The new definitions are the result of the JS’s work on a new information general chapter on excipient composition and impurities, considering feedback from stakeholders, responses to surveys, as well as discussions on the excipient components with the Excipient Nomenclature Joint Subcommittee.