USP Pharmaceutical Analytical Impurities
Used together with official USP Reference Standards, USP PAIs provide a comprehensive solution for your research and analytical needs
The global supply chain for medicines includes manufacturers and suppliers of drug products and their ingredients from around the world. To safeguard patient and practitioner trust in medicines, manufacturers must ensure that impurities in their drug products and their ingredients are properly controlled regardless of who makes them and how they are produced.
Thus, impurity analysis and profiling is critical during drug development and throughout the product life cycle. USP’s new suite of Pharmaceutical Analytical Impurities, used together with official USP Reference Standards, provides for a comprehensive solution to your research and analytical needs.
Pharmaceutical Analytical Impurities are released through a USP quality process designed to ensure identity and quality appropriate for analytical applications. The release process follows rigorous internal policies, standard operating procedures, and USP Quality Management System requirements.
These impurities are supported with a product information sheet for each batch. USP’s Pharmaceutical Analytical Impurities, like official USP Reference Standards, can help you to save time and resources and reduce risks associated with quality and consistency.
Pharmaceutical Analytical Impurities, along with the accompanying product information sheet, can be used to:
- Conduct analytical tests during early formulation feasibility studies.
- Perform spiking studies during process R&D to demonstrate depletion upon recrystallization.
- Identify or confirm peaks by comparing retention times and/or spectra.
- Determine relative response factors.
- Determine degradation impurities produced during stress studies.
- Identify unknown impurities that formed during ICH stability conditions.
- Identify impurities that are present in the Reference Listed Drug.
- Develop, validate, and transfer analytical methods.
- Release Active Pharmaceutical Ingredients (API) or drug products by testing for impurities not listed in monographs.
Please note: PAI items are supported with a product information sheet and material safety data sheet for each lot. PAI products are different from official USP Reference Standards.
Are there products that you’d like to see added to the USP Pharmaceutical Analytical Impurities range? Send us your suggestions at email@example.com with “Suggestion for New USP PAI” in the subject line.