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.
| USP NITROSAMINE IMPURITIES | |||
|---|---|---|---|
| Item # | Description | Item # | Description |
| 1A04220 | 1A04250 | ||
| 1A04240 | 1A04200 | ||
| 1A04230 | 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) |
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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.