Screening Methods for Elemental Impurities: Proposed Compendial Requirements
Event Date: June 14, 2012 at 11:00 AM EDT for North America and on June 21, 2012 at 11:00 AM CET for Europe

The revised US Pharmacopeia revised chapters on elemental impurity limits and procedures (<232> and <233>) are to be published as final in June 2012 and will become official by the end of the year. Conformance to the standards will be required starting May 1, 2014, and companies are already beginning to make changes for implementation. At the same time, the International Conference on Harmonization (ICH) working group on elemental impurities, ICH Q3D, is continuing to develop a harmonized approach for controlling these impurities, including risk-assessment recommendations and safety limits for specific metals, that meet testing and regulatory filing requirements at the global level. This webinar will focus on the quantitative screening methods and procedures for detecting elemental impurities based on the new USP chapter (ICP-based tests versus qualitative colorimetric tests). Instrumentation, key challenges, best practices, and will be addressed.

Moderator:

Angie Drakulich

Editorial Director
Pharmaceutical Technology / Pharmaceutical Technology Europe/ BioPharm International

Speaker:


Thomas Devadder

Senior Analyst
SGS Life Science Services, Germany

Kahkashan Zaidi PhD
Senior Scientist
US Pharmacopeia

Nancy Lewen
US Pharmacopeia Elemental Impurities Advisory Panel Member, and Principal Scientist
Bristol-Myers Squibb





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