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Analysis of Extractables and Leachables: Methodologies, Regulations, Best Practices Series

Highly publicized incidents and stricter regulatory controls have put a sharper focus on the analysis of extractable and leachable compounds in pharmaceutical products. In this two-part webinar series, we will make a comprehensive review of current analytical methodologies and the regulatory landscape, as well as showing best practices for designing and setting up a study.

Key Learning Objectives

• Broad understanding of E&L analysis and its importance

• Regulatory landscape governing E&L analysis
     o Overview of USP chapters <661>, <1663>, <1664>

• Concentration thresholds used for E&L quantitation

• Best practices in E&L study design
     o Selection of Extraction conditions
     o Confident Identification of Unknowns
     o Quantitative Strategies

• Use of complementary and orthogonal analytical technologies in real world E&L analysis
     o GC/MS and GC/Q-TOF
     o Headspace GC analysis
     o LC/MS and LC/Q-TOF
     o Two dimensional LC
     o ICP-MS
     o Ion mobility Mass Spectrometry

• Overview of available software tools for compound identification and differential analysis
     o Mass Hunter structure determination tools
     o Mass Profiler Professional
     o Mass Hunter Profinder
     o PCA analysis
     o Personal Compound Database Libraries for E&L screening

• Future perspectives on where analysis of E&L is headed in terms of practice and new analytical technology

Speakers   

PART ONE


Smriti Khera, Ph. D
Global Pharma Segment Marketing Manager
Agilent Technologies, Inc.


Mark Jordi, Ph.D.
President
Jordi Labs


Moderator:

Celia Arnaud
Senior Editor
C&EN


PART TWO


Kevin Rowland
Laboratory Manager
Jordi Labs


David Weil, Ph.D.
Sr. Application Scientist
Agilent Technologies, Inc.


Moderator:

Stu Borman
Senior Correspondent
C&EN

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