2020–2025 Simple Excipients Expert Committee Work Plan

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Focus Areas

  • Inorganic minerals
  • Small molecules
  • Sweeteners

Expert Committee Charge

The Simple Excipients Expert Committee is charged with developing new and revising existing monographs and their associated reference standards for pharmaceutical excipients. The Expert Committee advocates for the use of excipient standards for pharmaceutical use. It also employs the stakeholder engagement model by collecting information, convening stakeholders, communicating formally and informally (PF, journal articles, Stimuli articles and e-newsletters) and sharing information through educational courses and allowing meeting Observers.

Key Issues

Working with Stakeholders to address the following Key Issues:

  • Developing new and revising existing USP-NF monographs and associated RS though the introduction of more specific analytical tests for Identification, assay, impurities and other tests that help to establish the quality of the pharmaceutical excipient
  • Collaborating with the Excipients Test Methods Expert Committee in identifying opportunities to introduce improved analytical tests that add to the existing list of compendial tests
  • Developing guidelines to define excipient nomenclature, impurities and composition, co-processed, and novel excipients
  • Advocating for the use and implementation of USP-NF excipient monographs and associated standards for pharmaceutical use

 

Subcommittees and Expert Panels

  • Talc Methods Expert Panel
  • Lactoses Joint Subcommittee
  • Small Molecules Subcommittee
  • Inorganic Minerals Subcommittee
  • Sweeteners Subcommittee

Standards Development

  • The latest documentary standard ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here. 

Learn more about the impact of this EC and its Associated Expert Bodies

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