Overview of USP and Ph.Eur. Allowable Adjustments for HPLC Monograph Methods

ZÁZNAM | Proběhlo Út, 23.2.2021
V tomto webináři se budeme věnovat přehledu USP a vztahu k americkému FDA, přehledu Ph.Eur. a povolené úpravy na Ph.Eur. Obecná poznámka 2.2.46. Chromatografické separační techniky.
Phenomenex: Overview of USP and Ph.Eur. Allowable Adjustments for HPLC Monograph Methods
Phenomenex: 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)

Phenomenex
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