Overview
ExcipientFest attracts Pharmaceutical Scientists from the Americas and around the world to a unique two day forum for cutting-edge scientific developments. ExcipientFest features in-depth technical talks on Excipient Technology, New Drug Applications and Regulatory Issues from industry’s top-pharmaceutical experts. The seminar is designed to have a total science focus and to be true to the role of functionality of pharma ingredients in the formulation process.
USP is proud to continue its partnership with ExcipientFest in 2018 to bring focus to our role in standard setting for excipients. This year, we will also highlight the global supply chain risk mitigation benefits of our Ingredient Verification Program for Excipients. Visit us at Booth #2 to answer any questions you may have about USP and our focus on quality of ingredients in global drug manufacturing.
USP at ExcipientFest
Educational Program
Tuesday, May 1, 9:30 – 10:15 am, Hall B
Development of Up-to-Date Methods for USP/NF Excipient Standards
Hong Wang, Ph.D., Senior Manager, Science – Excipients
Abstract: The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that publishes monograph standards for identification and testing of drug products, excipients, foods and dietary supplements, among other related products. USP’s monographs and over 3500 reference standards are used in more than 140 countries for regulatory and industry quality control. Supported by FDA and by public and industry outreach efforts, the USP monograph Up-to-Date initiative continues to improve the relevance and quality of excipient standards to help qualify excipients for their intended use and assure the quality of pharmaceutical products, in furtherance of USP’s stated mission of improving global public health. Compendial standards in existence for a long period of time require updates to keep pace with current regulatory and safety requirements and to incorporate advances in analytical methodology and metrological science. The modernization replaces outdated and nonspecific methodology with analytical procedures that provide improved specificity, accuracy, precision, and sensitivity. USP expert committees work with external stakeholders and internal laboratories to develop up-to-date methods that provide unique identity and better characterization of an excipient. This presentation provides examples of recent up-to-date approaches that significantly improve the quality of excipient standards.
USP Posters:
Q&A sessions will be in the afternoon of Tuesday, May 1
- Risk Assessment & Sourcing Strategies for APIs & Excipients
Stephen W. Andruski, Ph.D. - Molecular Weight Determination for Guar Gum: Feasibility of High Performance Size Exclusion Chromatography Coupled with Light Scattering Methodology for Compendial Use
Joshua Bhattacharya, Natalia Kouznetsova, Mitan Gokulgandhi, Nadejda Soukhova, Jennifer Belsky - USP Up-To-Date Quality Standards for Excipients
Saccharin Family Monographs – Focus on Assay and Impurity
Tong (Jenny) Liu, Changhai Yin, Jesse Jiang, Catherine Sheehan