CSL Co-Hosts Webinar on Steps to Implementing USP <232> and <233>

Francine Walker, our Technical Director, was a guest speaker on a webinar that CSL co-hosted with Spectroscopy and Milestone Inc.

Elemental impurities in pharmaceutical products can be introduced from a number of sources, including catalysts, raw materials, production processes, and packaging materials. The implementation of the new USP chapters <232> and <233> on elemental impurities, in January 2018, will redefine how the pharmaceutical industry tests for elemental impurities in drug products. These chapters, which will replace the current USP chapter <231> on the sulfide colorimetric method, require the quantitative determination of individual metal concentrations via ICP-MS and ICP-OES and will place a major emphasis on robust sample preparation.
In this seminar we educated attendees on the method requirements, defined key parameters, and discussed considerations laboratories should make as they get themselves ready to implement the new methods. Through incorporating case studies, we discussed the importance of sample preparation and choosing the correct analytical technique to maximize data quality.
Key Learning Objectives
  • Review and discuss latest requirements of USP <232> and <233>
  • Determining whether to use ICP-OES or ICP-MS
  • Importance, options, and best practices for sample preparation — specifically microwave digestion
  • Guidance for how to manage the timeline for validating the new methods
  • Real world examples for analysis of raw materials and final drug products

To watch a recording of the webinar, please register using this link: www.spectroscopyonline.com/spec/Guidance