Events / Exhibitions
Exhibition Analytical Chemistry
USP Quantitative NMR Symposium Presentations
Outline
- Title
- USP Quantitative NMR Symposium
- Hosted by
- United States Pharmacopeia (USP)
- Co-sponsored
- USP-China
- Schedule
- November 16th - 17th, 2021
- Venue
- Online
- Registration fee
- Free
- Registration
- Please register from the application form URL.
Presentation details
Title: Lifecycle Approach to Method Validation of QNMR Analytical Procedure (TBD)
USP NMR General Chapters [761] and [1761] Applications of Nuclear Magnetic Resonance Spectroscopy are currently being revised by the quantitative nuclear magnetic resonance (qNMR) Expert Panel. One major purpose of this revision is to align with the proposed new USP General Chapter: The Analytical Procedure Lifecycle <1220>, which is aligned with Analytical Quality by Design (AQbD) concepts and offers a lifecycle approach to method validation, method transfer and verification of analytical procedures. In this presentation, the outline of life cycle approach to method validation for qNMR analytical procedure will be discussed, focusing on the concepts of Analytical Target Profile (ATP) utilizing Target Measurement Uncertainty (TMU), Quality Risk Management (QRM), instrument qualification and evaluation of measurement uncertainty.