Helping to Ensure Reliability and Stability of Drug Reference Materials
Global regulatory agencies, including the U.S. FDA, are increasingly concerned about nitrosamine impurities in medicines and their potential carcinogenic risks. With growing pressure to ensure compliance while avoiding delays in product approvals and release, there can’t be any second guessing when it comes to the quality of the reference materials you choose to identify, characterize, and quantify nitrosamines including Nitrosamine Drug Substance-Related Impurities (NDSRIs) in your drug products.
Recent product recalls linked to nitrosamine impurities in some commonly prescribed drugs have further highlighted the need for reliable analytical tools to help mitigate risk of impurities exceeding acceptable limits.
Leveraging our deep subject matter expertise on nitrosamines, synthetic chemistry and analytical method development, USP’s expanded portfolio of nitrosamine reference materials can help you achieve confidence in your analytical testing results.
- Over 60 well-characterized USP Pharmaceutical Analytical Impurities (PAI)* for simple nitrosamines and nitrosamine drug substance related impurities (NDSRIs) associated with drug substances like Sitagliptin, Duloxetine, Rasagiline, and Cinacalcet
- Eight USP Reference Standards to support methods in General Chapter <1469> Nitrosamine Impurities
USP Nitrosamines Exchange: A knowledge-based, online community for all-things nitrosamine.
Join USP's Nitrosamines Exchange for real-time conversations and insights from industry leaders. Learn about the latest strategies for reducing the risks related to nitrosamines.
Unlock the USP Case Study: Carcinogenic Potency Categorization Approach (CPCA) for NDSRI Evaluation
Help shape the future of Pharmaceutical Analytical Impurities.
USP’s catalog of Pharmaceutical Analytical Impurities is growing rapidly. However, please tell us if you do not find a Nitrosamine required for your analytical work, by connecting with your USP Account Manager or emailing 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. PAI products are not required for compendial compliance.