Nitrosamines

Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. EU regulators first became aware of nitrosamines in medicines in mid-2018 when nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were detected in blood pressure medicines known as 'sartans'. There is a very low risk that nitrosamine impurities at the levels found in medicines could cause cancer in humans.

  • FDA has been investigating the presence of impurities, called nitrosamines, in some types of medications.
  • Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines.
  • FDA, in collaboration with regulatory counterparts around the world, has set internationally-recognized acceptable daily intake limits for nitrosamines. If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate.
  • Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.
  • Patients taking prescription medications with potential nitrosamine impurities should not stop taking their medications. Patients should talk to their health care professionals about concerns and other treatment options.
  • Consumers taking over-the-counter medications with potential nitrosamine impurities may consider using other OTC products approved for their condition.
  • Find information about medications that have been recalled due to potential nitrosamine impurities on the FDA recalls webpage.
  • The agency is working to determine the source of these impurities and will keep the public informed.

  • The European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and has provided guidance to marketing authorisation holders to avoid the presence of nitrosamine impurities.

1-Nitroso 1,2,4-triazole
nitrosamine impurity chemical structure
CAT Number CHR-9122018-4226
CAS Number 70890-80-1
Mol.F C2H2N4O2
Mol.Wt 114.063 g/mol
Inventory status In-Stock
N-Ethyl-N-nitrosourea
nitrosamine impurity chemical structure
CAT Number CHR-9122018-4225
CAS Number 759-73-9
Mol.F C₃H₇N₃O₂
Mol.Wt 117.11 g/mol
Inventory status In-Stock
N-Nitroso dibutylamine
nitrosamine impurity chemical structure
CAT Number CHR-9122018-0301
CAS Number 924-16-3
Mol.F C8H18N2O
Mol.Wt 158.241 g/mol
Inventory status In-Stock
N-Nitroso Diethylamine (NDEA)
nitrosamine impurity chemical structure
CAT Number CHR-9122018-0305
CAS Number 55-18-5
Mol.F C4H10N2O
Mol.Wt 102.135 g/mol
Inventory status In-Stock
N-Nitroso dimethylamine (NDMA)
nitrosamine impurity chemical structure
CAT Number CHR-9122018-0306
CAS Number 62-75-9
Mol.F C2H6N2O
Mol.Wt 74.082 g/mol
Inventory status In-Stock
N-Nitrosodiisopropylamine (NDIPA)
nitrosamine impurity chemical structure
CAT Number CHR-9122018-0303
CAS Number 601-77-4
Mol.F C6H14N2O
Mol.Wt 130.188 g/mol
Inventory status In-Stock
N-Nitrosoethyl isopropyl amine (NEIPA)
nitrosamine impurity chemical structure
CAT Number CHR-9122018-0304
CAS Number 16339-04-01
Mol.F C5H12N2O
Mol.Wt 116.2 g/mol
Inventory status In-Stock
N-Nitrosomorpholine
nitrosamine impurity chemical structure
CAT Number CHR-9122018-1541
CAS Number 59-89-2
Mol.F C4H8N2O2
Mol.Wt 116.118 g/mol
Inventory status In-Stock
N-Nitroso-N methylaniline
nitrosamine impurity chemical structure
CAT Number CHR-9122018-0302
CAS Number 614-00-6
Mol.F C7H8N2O
Mol.Wt 136.151 g/mol
Inventory status In-Stock
N-Nitroso-N-metyl-4-aminobutyric acid (NMBA)
nitrosamine impurity chemical structure
CAT Number CHR-9122018-1137
CAS Number 61445-55-4
Mol.F C5H10N2O3
Mol.Wt 146.145 g/mol
Inventory status In-Stock
1-Methyl-3-nitro-1-nitrosoguanidine
nitrosamine impurity chemical structure
CAT Number CHR-9122018-3595
CAS Number 70-25-7
Mol.F C2H5N5O3
Mol.Wt 147.093 g/mol
Inventory status In-Stock
N-Nitroso Aceclofenac
nitrosamine impurity chemical structure
CAT Number CHR-9122018-4851
CAS Number NA
Mol.F C16H12Cl2N2O5
Mol.Wt 383.18 g/mol
Inventory status In-Stock
N-Nitroso N-Desmethyl DEBA
nitrosamine impurity chemical structure
CAT Number CHR-9122018-4625
CAS Number NA
Mol.F C9H20N2O3
Mol.Wt 204.27 g/mol
Inventory status In-Stock
N-Nitroso Nifedipine
nitrosamine impurity chemical structure
CAT Number CHR-9122018-4907
CAS Number NA
Mol.F C17H17N3O7
Mol.Wt 375.34 g/mol
Inventory status In-Stock
N-Nitroso-Felodipine
nitrosamine impurity chemical structure
CAT Number CHR-9122018-4908
CAS Number NA
Mol.F C18H18Cl2N2O5
Mol.Wt 413.25 g/mol
Inventory status In-Stock
N-Nitrosopiperidine (NPIP)
nitrosamine impurity chemical structure
CAT Number CHR-9122018-1582
CAS Number 100-75-4
Mol.F C5H10N2O
Mol.Wt 114.146 g/mol
Inventory status In-Stock