Over 200 New Pharmaceutical Analytical Impurities have been added to our catalog.
Our PAI portfolio now has over 700 impurity analytical reference materials covering over 150 Active Pharmaceutical Ingredients (APIs) across 35 therapeutic categories. PAI products include impurities listed in USP monographs but not available as USP Reference Standards as well as critical degradants and process impurities. As a leading provider of official Reference Standards trusted by thousands of manufacturers and regulators around the world, USP offers PAI analytical reference materials to support your impurity-related needs.
Why you need Pharmaceutical Analytical Impurities
USP’s Pharmaceutical Analytical Impurities (PAI)* advances your early analytical R&D and process development. Each USP PAI is supported by its own Product Information Sheet with details on identity and purity and can be used in various applications:
- conduct analytical tests during early formulation feasibility studies
- determine degradation impurities produced during stress studies
- develop, validate and transfer analytical methods
- perform spiking studies during process R&D to demonstrate depletion upon recrystallization
- retention times and/or spectra
- determine relative response factors
- identify unknown impurities that formed during ICH stability conditions
- identify impurities which are present in the Reference Listed Drug
- test for and profile impurities not listed in drug substance and drug product monographs
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 related to nitrosamine drug substance-related impurities (NSDRIs).
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 USP’s Analytical Materials Technical Services team at AMtech@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. PAI products are not required for compendial compliance.