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Analysis of Elemental Impurities

Course Information:

Course Description:


This course will cover the revisions of chapters <232> / <233> that appeared in Second Supplement to USP 35–NF 30 (official Dec 1, 2012) for analysis of Elemental Impurities in pharmaceutical materials. The course addresses the elements and how limits are set. It will explain how it applies to products and goes through a brief method description. Recent changes will be highlighted as well as the implementation timeframe.

Who Should Attend:


Analytical chemists, QC managers, QA managers, compliance managers, lab managers, production managers and any individual in the pharmaceutical industry with an interest in the application of ICP and ICP-MS to the analysis of metals in API’s, excipients, and drug products.

Duration:


3 Hours

Learning Objectives and Course Outline:


Learning Objectives
  • Explain the recent changes that occured in the Chapters <232> and <233> in the Second Supplement to USP35 and the implementation timeframe for the new requirements to become official
  • Understand the issues associated with USP Chapter <231>--Heavy Metals that resulted in development of new proposed chapters on elemental impurities
  • Understand the scope and context of USP’s new chapters on elemental impurities
  • Develop an understanding of how the limits are applied to products
  • Explain proposed procedures and acceptance criteria

Contact Information:


PharmEd@usp.org