Pharmaceutical Analytical Impurities

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. Our new suite of Pharmaceutical Analytical Impurities*, together with our portfolio of 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. These impurities are supported with a product information sheet for each batch. By using impurities from your most trusted source, 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.

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Potential applications
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.

Help shape the future of Pharmaceutical Analytical Impurities.
USP’s catalog of Pharmaceutical Analytical Impurities is growing rapidly. Please tell us about the APIs for which available impurities would have the most benefit to your work. Connect with your USP Account Manager or email us at PAI@usp.org.

*Pharmaceutical Analytical Impurities are released using a process developed by USP’s subject matter experts. The release process is based on internal policies, standard operating procedures, and requirements as defined by USP’s Quality Management System. USP is an ISO 9001:2015 certified facility. PAI products are different from official USP Reference Standards.