The deadline for implementation of the new elemental impurities guidelines for drug products and ingredients is fast approaching. Implementation is scheduled for January 2018, by which time manufacturers of pharmaceutical drug products must comply with USP <232>/<233> and ICH Q3D.
Recent harmonization between USP <232> and ICH Q3D, has resulted in complete alignment of the number of analytes and PDEs. In this webinar we will summarize the most recent updates.
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Pharmaceutical products can be a complex mix of excipients and APIs, requiring reliable solubilization and accurate analysis. The webinar will address the recommended approach for the preparation and testing of excipients by ICP-MS and ICP-OES.
Case studies will be presented for both instruments, highlighting workflow operation from sample decomposition to data analysis and reporting.
Participants Will Learn:
- The timeline for developing analysis methods for compliance with ICH Q3D and USP <232>/<233>
- Attributes of ICP-MS and ICP-OES
- Challenges and solutions for matrix dissolution
- Method validation requirements
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Speakers
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Mark Kelinske,
Applications Chemist,
Agilent Technologies
Alexandra Taylor,
Associate Editor,
C&EN
