Tackling the Challenge of Nitrosamines

New Nitrosamine Pharmaceutical Analytical Impurities (PAIs) 

USP's portfolio of nitrosamine solutions now includes Pharmaceutical Analytical Impurities for an expanding variety of simple nitrosamines and nitrosamine drug substance-related impurities (NDSRIs). 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.

Setting the Standard for Quality

Our nitrosamine portfolio includes highly characterized Reference Standards and new nitrosamine PAIs, some of which are listed below.

Item # Description Item # Description

N-Nitroso Atenolol Solution


N-Nitroso Bisoprolol Solution


N-Nitroso Labetalol Solution


N-Nitroso Metoprolol Solution


N-Nitroso Propranolol Solution

1A04450 N-Nitroso Quinapril
1A03930 N-Nitrosodipropylamine (NDPA) Solution 1A04020 1-Methyl-4-nitrosopiperazine (MNP) Solution
1A04060 N-Nitrosopyrrolidine (NPYR) Solution 1A04190 1-Cyclopentyl-4-nitrosopiperazin (CPNP) Solution
1A04400 N-Nitrosoiminodiacetic acid 1A04080 1-(2-Methoxyphenyl)-4-nitrosopiperazine Solution
1A04420 1-Benzhydryl-4-nitrosopiperazine 1A04440 2-(4-Nitrosopiperazin-1-yl)pyrimidine
1A04410 4-Nitrosopiperazine-1-ethanol 1A04100 4-Nitrosopiperzine-1-ethanol Solution
1A04380 N-Nitroso Dabigatran Etexilate    
1175800 Deutero N-Nitrosodimethylamine (NDMA-d6)  1466607 N-Nitrosomethylphenylamine (NMPA)
1466641 N-Nitrosodibutylamine (NDBA) 1466674 N-Nitrosodimethylamine (NDMA)
1466652 N-Nitrosodiethylamine (NDEA) 1466685 N-Nitrosoethylisopropylamine (NEIPA)
1466663 N-Nitrosodiisopropylamine (NDIPA) 1466696 N-Nitrosomethylaminobutyric Acid (NMBA)


USP Nitrosamines Exchange: A knowledge-based, online community for all-things nitrosamine.

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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 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.