Mastering impurity profiling: USP’s evolving standards and strategies
Sponsored by 
USP2025-10-15T11:00:00
Watch our webinar with USP as they explored new approaches for impurity profiling - unveiling new frameworks, analytical tools, and regulatory insights that are reshaping pharmaceutical quality standards.
Watch our webinar with USP as they explored new approaches for impurity profiling - unveiling new frameworks, analytical tools, and regulatory insights that are reshaping pharmaceutical quality standards.
This webinar gave a quick introduction and background on impurities in drug substances and products. Major ICH Guidelines on impurities will be explained on a high level, as will be other guidelines derived from them, before diving into the respective USP quality standards around impurities.
Key learning points:
- How USP addresses impurities in general
- How specific challenges like DEG/EG contamination, Nitrosamines, and Extractables & Leachables are approached in the USP-NF
- How Pharmaceutical Analytical Impurities can complement the work with USP Reference Standards for impurities