Risks of non-compliance: managing impurity control and challenges with reference materials
Sponsored by 
USP2026-09-23T13:00:002026-09-23T13:00:002026-09-23T14:00:00
USP explored the latest approaches to organic impurity analysis and scientific solutions to support pharmaceutical quality, including regulatory expectations and practical applications of the USP Reference Standards.
Organic impurities remain a key challenge throughout the drug development lifecycle, compromising product quality, patient safety, and regulatory compliance. As such, their identification, monitoring and quantification is essential to quality control. Regulatory requirements for impurity analysis demand robust and stringent approaches, with the ICH guidelines providing a key framework for establishing appropriate standards.
To support the identification and control of organic impurities, USP provides Impurity Reference Standards for a wide range of drug products. These standards provide a recognised reference point for impurity assessment and quality control across the product lifecycle.
This webinar will provide a brief introduction and background to organic impurity analysis in drug substances and products, starting with exploring the ICH guidelines and subsequent guidance.
Watch on demand through your free European Pharmaceutical Review membership.
Regulatory expectations will be discussed using publicly available case examples, including Complete Response Letters, which illustrate how insufficient information on organic impurities, including nitrosamines and extractables/leachables, has contributed to FDA requests for application resubmission or other action. These cases will also highlight key considerations when testing impurities and developing and validating analytical methods.
The webinar explored solutions for impurities, considering how USP’s standards, reference materials and analytical methods can support robust impurity profiling.
Key learning points:
- The role and importance of organic impurity control.
- ICH guidance for identifying and controlling organic impurities.
- FDA expectations and considerations on impurity testing and qualification.
- Real-world examples of the impacts and limitations of using non-compendial reference materials in impurity analysis.
- Understanding how USP solutions support reliable impurity testing.