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.

  1. 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
  2. Eight USP Reference Standards to support methods in General Chapter <1469> Nitrosamine Impurities
EXAMPLES OF USP NITROSAMINE REFERENCE MATERIALS
Item # Description Item # Description
1A04000 N-Nitroso Duloxetine Solution 1A08890 N-Nitroso Cinacalcet Solution
1A11180 N-[(2-Isopropylthiazol-4-yl)methyl]-N-methylnitrous amide (NITMA) 1A04020 1-Methyl-4-Nitrosopiperazine Solution
1A05430 N-Nitroso Atomoxetine Solution 1466696 N-Nitrosomethylaminobutyric Acid (NMBA)
1A04360 N-Nitroso Sitagliptin Amine 1A03960 N-Nitroso Sitagliptin Amine Solution 
1A04030 N-Nitroso Rasagiline Solution 1A05410 Deutero N-Nitrosodiethylamine Solution
1A05420 Deutero N-Nitrosodibutylamine Solution 1A04380 N-Nitroso Dabigatran Etexilate 
1A03930 N-Nitrosodipropylamine Solution 1A03940 N-Nitrosomethylphenidate Solution
1A04390 N-Nitroso Tamsulosin  1A03950 N-Nitrosopiperidine Solution
1A04200 N-Nitroso Metoprolol Solution 1A04240 N-Nitroso Labetalol Solution
1A04230 N-Nitroso Propranolol Solution 1A04220 N-Nitroso Atenolol Solution 
1A04250 N-Nitroso Bisoprolol Solution  1A03920 N-Nitroso Varenicline Solution
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)    
EXAMPLES OF USP NITROSAMINE REFERENCE MATERIALS
Item # Description
1A04000 N-Nitroso Duloxetine Solution
1A08890 N-Nitroso Cinacalcet Solution
1A11180 N-[(2-Isopropylthiazol-4-yl)methyl]-N-methylnitrous amide (NITMA
1A04020 1-Methyl-4-Nitrosopiperazine Solution
1A05430 N-Nitroso Atomoxetine Solution
1A04020 1-Methyl-4-Nitrosopiperazine Solution
1A04360 N-Nitroso Sitagliptin Amine
1A03960 N-Nitroso Sitagliptin Amine Solution 
1A04030 N-Nitroso Rasagiline Solution
1A05410 Deutero N-Nitrosodiethylamine Solution
1A05420 Deutero N-Nitrosodibutylamine Solution
1A04380 N-Nitroso Dabigatran Etexilate 
1A03930 N-Nitrosodipropylamine Solution
1A03940 N-Nitrosomethylphenidate Solution
1A04390 N-Nitroso Tamsulosin 
1A03950 N-Nitrosopiperidine Solution
1A04200 N-Nitroso Metoprolol Solution
1A04240 N-Nitroso Labetalol Solution
1A04230 N-Nitroso Propranolol Solution
1A04220 N-Nitroso Atenolol Solution 
1A04250 N-Nitroso Bisoprolol Solution 
1A03920 N-Nitroso Varenicline Solution
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. 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.