Tackling the Challenge of Nitrosamines
New Nitrosamine Reference Materials
Setting the Standard for Quality
Recent recalls due to nitrosamines in some commonly prescribed drugs have manufacturers grappling with how best to mitigate the risk of these impurities above acceptable levels.
Given the heightened regulatory scrutiny over these impurities and their potential to directly impact patient health, there can’t be any second-guessing when it comes to the quality of the reference materials you choose to identify, characterize and control nitrosamines in your drug product.
Thus, leveraging our deep subject matter expertise on nitrosamines, synthetic chemistry and analytical development, USP has expanded its portfolio of nitrosamine reference materials to include:
- Over 60 well-characterized Pharmaceutical Analytical Impurities (PAI)* for simple nitrosamines and NDSRIs associated with drug substances like Sitagliptin, Duloxetine, and Rasagiline
- 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.
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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.