Learning Tracks

USP Excipient Nomenclature and Advanced Analytical Procedures for Characterization of Polymeric Excipients

Monday, October 21, 2024

3:15 p.m. - 4:15 p.m.

Brookside

This presentation will introduce the USP Excipient Nomenclature Guidelines released to the public in 2023 and is the first USP nomenclature guidelines for excipients. Applications of more advanced analytical techniques for complex excipients lead to appropriate naming. This discussion will also delve into how the guidelines help align the names in USP/NF standards, FDA inactive ingredient database, and the FDA global substance registration system; address FDA’s Q1 sameness requirements for complex generics to indicate excipient types in meeting the needs of complex generics and innovative therapeutics; and to guide stakeholders to understand excipient composition and profiles.

Hong Wang
Senior Manager, Science & Standards Excipients, USP

Brett Howard, J.D., PhD
Senior Director, US Regulatory Policy
Global External Affairs, USP