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_____ Brought to you by Agilent Technologies _____

Impact of Analytical Methodology and Reference Standard Selection on Extractables Profiling from Single-Use Systems and Medical Devices

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  June 21, 2018

  First Session: USA 9:00am EDT, 6:00am PDT, 14:00 BST

  Repeat Session: USA 12:00pm EDT, 9:00am PDT, 17:00 BST

 

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Regulatory authorities have issued guidance (USP 1663, USP 1664, USP 661 and ISO 10993) and draft guidance (USP665) on E&L analyses for products used in the manufacturing or packaging of pharmaceuticals.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.

Another requirement for extractables profiling is to quantitate the level of extractables present in samples to perform meaningful risk assessment. This involves semi-quantitation in the absence of standards in many cases. In this webinar we will also demonstrate how the choice of reference standard selection impacts results from these studies.

We will summarize findings from our recent publication JPBA 2018, 150, 368-376. As well as, show new case studies and examples to illustrate benefits of the proposed analytical methodology

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Key Learning Objectives

  • Overview of USP 1663, USP1664, ISO10993 and Draft USP665
  • Streamlined workflow for LC/MS and GC/MS
  • Automated software-assisted feature detection, differential analysis and extractables identification for both LC/MS and GC/MS
  • Benefits of using Low Energy EI GC/Q-TOF for identification of volatiles and semi-volatiles
  • Use of reference databases of extractables representing different chemical classes for compound identification
  • Important factors to consider when performing relative quantitation to maximize accuracy

Who Should Attend

  • E&L analysts and Lab managers
  • Researchers interested in E&L Testing in Food/Pharma/Medical Device/Consumer Products/Polymer Manufacturing/CRO's/CMO's and other
  • Quality Assurance experts in above industries
  • Biopharmaceutical development teams and Bioprocess engineers
 

Speakers

Smriti Khera, Ph.D.,
Global Pharma Marketing Manager,
Agilent Technologies
Mark Jordi, Ph.D.,
President,
Jordi Labs
 

Moderator

Ann Thayer,
Contributing Editor,
C&EN Media Group
 

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