Tackling the Challenge of Nitrosamines
An expanding catalog of Nitrosamine Pharmaceutical Analytical Impurities (PAIs)
Setting the Standard for Quality
The detection of carcinogenic nitrosamines in some commonly prescribed drugs has manufacturers grappling with how best to mitigate the risk of these impurities above acceptable levels.
There can be no second-guessing with the quality of reference materials used to evaluate drug quality issues that have direct impact on patient health and regulatory outcomes, like those in case of nitrosamines. You deserve the best.
USP has thus, leveraging on its deep subject matter expertise on nitrosamines, synthetic chemistry and analytical development, expanded its portfolio of nitrosamines reference materials to include:
- Over 60 well characterized nitrosamines Pharmaceutical Analytical Impurities for simple nitrosamines and NDSRIs associated with drug substances like Sitagliptin, Duloxetine, Rasagiline, etc.
- Eight nitrosamine Reference Standards.
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.
Sign up to be notified when future USP Nitrosamine Impurities are released.
Help shape the future of nitrosamine PAIs.
USP’s catalog of nitrosamines PAIs is growing rapidly. Please let us know if you need particular nitrosamine reference materials that is not available with USP. 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. PAI products are not required for compendial compliance.