Overview of USP and Ph.Eur. Allowable Adjustments for HPLC Monograph Methods
Join us for a talk focused on reversed-phase chromatography and best practices to selecting a reproducible starting point for your initial method development.
These tips will help you leverage HPLC and UHPLC column particle morphologies to improve or optimize a specific aspect of your separations. We will discuss separation tradeoffs such as maximizing the relative speed of analysis of your method, versus the need for increased selectivity or compound retention.
We will also present ways for improving your method's reproducibility through robust method development and ways to ensure reproducibility through the lifecycle of the method.
Overview of USP and the relation to US FDA
Allowable adjustments per USP General Chapter <621>
Overview of Ph.Eur. and the relation to EDQM
Allowable adjustments per Ph.Eur. General Notice 2.2.46. Chromatographic Separation Techniques
Presenter: Phil Koerner, PhD (Pharmaceutical Market Development Manager, Phenomenex)
