Strategies for E&L: Improve study quality, reliability and adherence to guidance

  • 60 Minutes

60 Minutes
  • Overview

    Regulatory authorities have issued guidance (USP 1663, USP 1664, USP 661 and ISO 10993) and draft guidance (USP665) on E&L analyses for products used in the manufacturing or packaging of pharmaceuticals. These documents provide recommendations regarding methods of identification but leave decisions as to the exact analytical methodology to the sponsor. Extractables profiling involves extensive use of LC/MS and GC/MS to get a complete picture of volatile, semi-volatile and non-volatile organics from complicated extracts and samples with high matrix background peaks. The sample preparation and data analysis and processing methodology used can have a significant impact on the results. In this webinar we will review our proposed approach for streamlining LC/MS and GC/MS data analysis and use both automated feature detection and differential analysis to simplify workflows and improve productivity. We will also go into why and how this methodology is preferable over manual data processing and leads to improved result quality and identification of true positives.
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    Brought to you by:

    Agilent Technologies
  • Speakers

    Smriti Khera, Ph.D.,
    Global Pharma Marketing Manager,
    Agilent Technologies
    Mark Jordi, Ph.D.,
    Jordi Labs
    Ann Thayer,
    Contributing Editor,
    C&EN Media Group