Let your voice be heard!
Join the Excipients Stakeholder Forum – Shape the Future of USP Excipients Standards
The United States Pharmacopeial Convention (USP) will host a virtual Excipients Stakeholder Forum on December 9 and 11, 2025, at 8:30 a.m. – 12:30 p.m. EST, each day. Please join us online as we gather stakeholder feedback to help contribute to the future of USP excipients standards.
Registration is free, and advance registration is required.
Why attend?
We are seeking input from stakeholders in areas such as:
1. Influence the Future of USP Standards
Stakeholders will have a unique opportunity to directly contribute to the evolution of USP excipient standards. By sharing their insights and challenges, participants can interact and help to shape practical, science-based guidelines that reflect real-world complexities in excipient characterization.
2. Clarify Regulatory and Scientific Ambiguities
The distinction between minor components and organic impurities is often unclear and inconsistently interpreted. This event offers a platform to:
- Gain clarity on definitions and expectations on <1068> Excipient Composition and Organic Impurities chapter in development
- Discuss pain points with peers and experts,
- Explore case studies and regulatory perspectives that can inform better compliance and formulation strategies.
3. Collaborate with Industry Leaders
Attendees will connect with a diverse group of stakeholders—including scientists, regulators, formulators, and quality professionals. This collaborative environment fosters:
- Knowledge exchange
- Strategic partnerships
- And a deeper understanding of emerging trends and technologies in excipient development and analysis.
Who should attend?
- Excipient Manufacturers and Suppliers
- Pharmaceutical Scientists and Formulators
- Quality Assurance and Quality Control Specialists
- Analytical Chemists
- Academics and Researchers
- Regulatory Agency Representatives and Pharmacopeial Officials
- CDMO, CLO and CMO’s
New General Chapter Prospectus: General Chapter Prospectus: Excipient Composition and Organic Impurities | USP-NF
Preliminary agenda:
Day 1:
- What is an excipient of the Future?
- USP Compendial process for Developing Excipients Composition and impurities standards
- Overview of pharmacopeial standards-setting for excipients across globe: Commonalities/Differences
- USP overview of <1068> Excipient Composition and Organic Impurities in development
- Industry perspective: Excipient Composition and Nomenclature
Day 2:
- US FDA perspective on Excipients Quality standards
- Application of USP standard setting approaches to characterize different types of excipients utilizing stakeholder engagement
- Industry Case Study: Does less of an excipient “impurity” always mean better quality?
- Overview of <320> NMR Spectroscopy for the Determination of Degree of Hydrolysis for Polyvinyl Alcohol and Vinyl Alcohol Homopolymer, and Monomer Ratio for Vinyl Alcohol and Vinyl Acetate Copolymer (TBC)
- USP’s overview of approaches to developing standards for PLG and PLGA type excipients
- Panel Discussion: Title/Topics: “Live prospectus” Discussion on <1068> Excipient Composition and Organic Impurities development; Expectations and next steps
Secure your spot today and be part of the conversation!
Don’t miss this opportunity.
Meeting Details:
Date and Time & Venue
- December 9, 8:30 a.m. – 12:30 p.m. EST
- December 11, 8:30 a.m. – 12:30 p.m. EST
- Location: Virtual (Webex Link will be shared soon)
Register (Final agenda and Speaker details will be shared soon.)