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Focus Areas
- Cellulosics
- Fats and Oils
- Polymers
- Starches
- Stearates
- Waxes
Expert Committee Charge
- The Complex 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 co-processed excipients/novel excipients, excipient nomenclature and impurities Advocating for the use and implementation of USP-NF excipient monographs and associated standards
- Advocating for the use and implementation of USP-NF excipient monographs and associated standards for pharmaceutical use
Subgroups and Expert Panels
- Excipient Science Strategy Joint Subcommittee
- Polysorbates Joint Subcommittee
- PLGA Joint Subcommittee
- Excipient Composition and Impurities Joint Subcommittee
- Cellulosics Subcommittee
- Polymers Subcommittee
- Fats, Oils, and Waxes Subcommittee
- Starches Subcommittee
- Stearates 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
- Our Work on Excipients
- Excipients Newsletter
- Novel Excipients: New Hope for Therapeutic Innovations
- 2017 USP-FDA Workshop
- Excipients Priority List - new and modernized
- Excipient Characterization: USP’s AAPS Chalk Talk Videos
- Excipients Stakeholder Forum
Articles
- Challenges and Opportunities in Developing Up-to-Date USP–NF Excipients PART 1
- Challenges and Opportunities in Developing Up-to-Date USP–NF Excipient Monographs PART 2
- Challenges and Opportunities in Developing Up-to-Date USP–NF Excipient Monographs PART 3
- Characterization of Polymeric Excipients
- USP Novel Excipients Survey: Stakeholders’ Views on the Current State of Excipient Innovation
Contact
- Catherine Sheehan, DRSc, MS., MS., Senior Director - Excipients, cxs@usp.org
- Richard Lew, MS., Expert Committee Manager- Excipients, rll@usp.org