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Pharmaceutical Analytical Impurities
Stay ahead in the evolving pharma market with USP's trusted analytical reference materials.
Our PAI portfolio now has over 900 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
