Modernizing LC Methods as per Harmonized USP Chapter 621
On December 1, 2022 a harmonized standard for General Chapter 621 Chromatography was released. This standard incorporates the USP with 2.2.46. Chromatographic Separation Techniques European Pharmacopoeia (EuPh) and 2.01 Liquid Chromatography Japanese Pharmacopeia (JP) texts. Harmonization of these regulatory guidance provides increased method flexibility through the employment of modernized of chromatographic tools without the need for full monograph re-validation.
The extent to which the various parameters of a compendial chromatographic test may be adjusted without fundamentally modifying the pharmacopeial analytical procedures is defined in U.S. Pharmacopeia (USP) General Chapter 621 Chromatography.
In this presentation, we combine the gradient method adjustments described in this chapter to achieve both column and system modernization for the USP monograph separation of antiviral drug abacavir sulfate.
Key Learning Objectives:
- Learn how to modernize the HPLC column and reduce operation costs using the USP 621 allowable adjustments
- Learn how to modernize the LC platform and further reduce operation costs using the USP 621 allowable adjustments
- Leverage Empower CDS fields to apply the updated chromatography reporting calculations
Who Should Attend:
- Scientists and lab managers involved with compendial methods with a drive towards modernization, productivity and compliance.
Presenter: Catharine Layton (Principal Scientist, Scientific Operations, Waters Corporation)
