Drug Nitroso Impurities

Nitrosoamines refer to any molecule containing nitroso (-N-N=O) functional group. According to WHO, these impurities are probable human carcinogens. Therefore they are of great concern. Although they are also present in some foods and drinking water supplies, their presence in medicines is nonetheless considered unacceptable. The recommended AI limit of 26.5 ng/day* is equal to the class-specific limit for nitrosamine impurities based on the most potent, robustly tested nitrosamine, N- nitrosodiethylamine (NDEA). The API and drug product manufacturers should take the appropriate action to check the levels of nitrosamine impurities in their products. Further, the API manufacturers should design the ROS (route of synthesis) for API development in such a way as to prevent the formation of nitrosamine impurities or to minimize its formation to the given limits. To quantify the presence of these impurities, we need impurity standards.

Image	Details
	Impurity Name: 1-(3-Chlorophenyl)-4-nitrosopiperazine IUPAC Name: 1-(3-chlorophenyl)-4-nitrosopiperazine CAS Number: 2219339-13-4 Molecular Formula: C10H12ClN3O Molecular Weight: 225.70 Status: available
	Impurity Name: N-Nitroso Propafenone IUPAC Name: N-nitroso-2-[2-[3-(propylamino)-2-hydroxypropoxy]phenyl]propiophenone CAS Number: 3036581-87-7 Molecular Formula: C21H26N2O4 Molecular Weight: 370.45 Status: available
	Impurity Name: N-Nitroso Chlorpromazine IUPAC Name: N-nitroso-2-chloro-10-(3-dimethylaminopropyl)phenothiazine CAS Number: 55855-44-2 Molecular Formula: C16H16ClN3OS Molecular Weight: 333.84 Status: available
	Impurity Name: N-Nitrosopiperidine IUPAC Name: N-nitrosopiperidine CAS Number: 100-75-4 Molecular Formula: C5H10N2O Molecular Weight: 114.15 Status: available
	Impurity Name: Mefenamic Acid Nitroso Impurity IUPAC Name: N-nitroso-2-[(2,3-dimethylphenyl)amino]benzoic acid CAS Number: 2114-63-8 Molecular Formula: C15H14N2O3 Molecular Weight: 270.28 Status: available
	Impurity Name: N-Nitroso Gatifloxacin IUPAC Name: N-nitroso-1-cyclopropyl-6-fluoro-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxoquinoline-3-carboxylic acid CAS Number: NA Molecular Formula: C19H21FN4O5 Molecular Weight: 404.39 Status: available
	Impurity Name: N-Nitroso Moxifloxacin IUPAC Name: N-nitroso-1-cyclopropyl-7-[(1S,6S)-2,8-diazabicyclo[4.3.0]nonan-8-yl]-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic acid CAS Number: NA Molecular Formula: C21H23FN4O5 Molecular Weight: 430.44 Status: available
	Impurity Name: N-Nitroso Albendazole IUPAC Name: N-nitroso-methyl [5-(propylthio)-1H-benzimidazol-2-yl]carbamate CAS Number: NA Molecular Formula: C12H14N4O3S Molecular Weight: 294.30 Status: available
	Impurity Name: N-Nitroso Ambroxol IUPAC Name: N-nitroso-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol CAS Number: NA Molecular Formula: C13H17Br2N3O2 Molecular Weight: 407.10 Status: available
	Impurity Name: N-Nitroso-Atomoxetine IUPAC Name: N-nitroso-N-methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine CAS Number: 3028194-77-3 Molecular Formula: C17H20N2O2 Molecular Weight: 284.36 Status: available
	Impurity Name: N-Nitroso-Atenolol IUPAC Name: N-nitroso-4-[2-hydroxy-3-(propan-2-ylamino)propoxy]benzamide CAS Number: 134720-04-0 Molecular Formula: C14H21N3O4 Molecular Weight: 295.33 Status: available
	Impurity Name: N-Nitroso Bupropion IUPAC Name: N-nitroso-2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one CAS Number: 2763780-10-3 Molecular Formula: C13H17ClN2O2 Molecular Weight: 268.74 Status: available
	Impurity Name: N-Nitroso-Desloratadine IUPAC Name: N-nitroso-8-chloro-6,11-dihydro-11-(piperidin-4-ylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine CAS Number: 1246819-22-6 Molecular Formula: C19H18ClN3O Molecular Weight: 339.82 Status: available
	Impurity Name: N-Nitroso Piperazine IUPAC Name: N-nitrosopiperazine CAS Number: 5632-47-3 Molecular Formula: C4H9N3O Molecular Weight: 115.13 Status: available
	Impurity Name: N-Nitroso Sertraline IUPAC Name: N-[(1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-yl]-N-methylnitrous amide CAS Number: NA Molecular Formula: C17H16Cl2N2O Molecular Weight: 335.23 Status: available
	Impurity Name: N-Nitroso Vildagliptin IUPAC Name: N-nitroso-[(3-hydroxyadamantan-1-yl)amino]acetylpyrrolidine-2-carbonitrile CAS Number: 3034601-47-0 Molecular Formula: C17H24N4O3 Molecular Weight: 332.40 Status: available
	Impurity Name: N-Nitroso Bisoprolol IUPAC Name: N-nitroso-1-[4-[(2-isopropoxyethoxy)methyl]phenoxy]-3-(propan-2-ylamino)propan-2-ol CAS Number: 2820170-76-9 Molecular Formula: C18H30N2O5 Molecular Weight: 354.44 Status: available
	Impurity Name: 2-Methyl-1-Nitrosopiperazine IUPAC Name: 2-methyl-1-nitrosopiperazine CAS Number: 1172850-85-9 Molecular Formula: C5H11N3O Molecular Weight: 129.16 Status: available
	Impurity Name: N-Nitroso Metoprolol IUPAC Name: N-nitroso-1-(isopropylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol CAS Number: 138768-62-4 Molecular Formula: C15H24N2O4 Molecular Weight: 296.37 Status: available
	Impurity Name: N-Nitroso Nifedipine IUPAC Name: N-nitroso-dimethyl 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)pyridine-3,5-dicarboxylate CAS Number: NA Molecular Formula: C17H17N3O7 Molecular Weight: 375.33 Status: available
	Impurity Name: N-Nitroso Olanzapine IUPAC Name: N-nitroso-2-methyl-4-(4-methylpiperazin-1-yl)-10H-thieno[2,3-b][1,5]benzodiazepine CAS Number: NA Molecular Formula: C17H19N5OS Molecular Weight: 341.43 Status: available
	Impurity Name: N-Nitroso Amlodipine IUPAC Name: N-nitroso-3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate CAS Number: NA Molecular Formula: C20H24N3O6Cl Molecular Weight: 437.88 Status: available
	Impurity Name: N-Nitroso Sitagliptin IUPAC Name: N-nitroso-3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazine CAS Number: 2892260-32-9 Molecular Formula: C6H6F3N5O Molecular Weight: 221.14 Status: available
	Impurity Name: N-Nitroso Valsartan Cyano Desvaleryl Methyl Ester IUPAC Name: N-nitroso-methyl (S)-2-(1H-tetrazol-5-yl)phenylvalerate CAS Number: NA Molecular Formula: C20H21N3O3 Molecular Weight: 351.40 Status: available
	Impurity Name: N-Nitroso Valsartan Impurity 1 IUPAC Name: N-nitroso-(S)-2-(1H-tetrazol-5-yl)phenylvaleramide CAS Number: 2254485-68-0 Molecular Formula: C19H20N6O3 Molecular Weight: 380.40 Status: available
	Impurity Name: N-Nitroso Tofacitinib IUPAC Name: N-nitroso-3-[(3R,4R)-4-methylpiperidin-3-yl]-3-oxopropanenitrile CAS Number: NA Molecular Formula: C13H18N6O Molecular Weight: 274.32 Status: available
	Impurity Name: N-Nitroso Despropyl Ropinirole IUPAC Name: N-nitroso-4-(2-dipropylaminoethyl)-1,3-dihydro-2H-indol-2-one CAS Number: NA Molecular Formula: C13H17N3O2 Molecular Weight: 274.32 Status: available