N-Nitrosodiethylamine

CAS Number	55-18-5
Molecular Formula	C4H10N2O
Molecular Weight	102.137 g/mol
InChI Key	WBNQDOYYEUMPFS-UHFFFAOYSA-N
LogP	0.5
Synonyms	Diethylnitrosamine 55-18-5 Diethylnitrosoamine NDEA N-Ethyl-N-nitrosoethanamine N,N-Diethylnitrosamine N,N-Diethylnitrosoamine Nitrosodiethylamine Ethanamine, N-ethyl-N-nitroso- Diethylnitrosamide Diethylamine, N-nitroso- Diaethylnitrosamin N-Nitroso-N,N-diethylamine DEN (mutagen) Ethylamine, N-nitrosodi- DENA N,N-diethylnitrous amide RCRA waste number U174 N-Diethylnitrosamine NSC 132 DEN Nitrosamine, diethyl- N-Nitroso-diaethylamine C4H10N2O UNII-3IQ78TTX1A Diaethylnitrosamin [German] CCRIS 239 N-Ethyl-N-nitroso-ethanamine HSDB 4001 N-Nitroso-diaethylamine [German] EINECS 200-226-1 RCRA waste no. U174 BRN 1744991 3IQ78TTX1A 1,1-Diethyl-2-oxohydrazine AI3-62031 CHEBI:34873 WBNQDOYYEUMPFS-UHFFFAOYSA-N N-Nitrosodiethlamine

Applications:

HPLC Method for Analysis of N-Nitrosodiethylamine on Newcrom R1 Column

N-Nitrosodiethylamine (NDEA) or Diethylnitrosamine is potential carcenogenic agent was found in some blood pressure medications. Those medications were recalled by FDA with the concern of high concentration of the chemical. SIELC developed simple and fast HPLC method to measure presence of NDEA in drug formulations. This UV based method allows to detect ppb level of the compound in solution. Simple mobile phase comprised of acetonitrile (MeCN) and water with detection at 2** nm using Newcrom R1 column can be used to detect both the API and the NDEA.

Condition
Column	Newcrom R1, 4.6x150 mm, 5 µm, 100A
Mobile Phase	MeCN - 20-80%
Buffer	No
Flow Rate	1.0 ml/min
Detection	UV, 232 nm

Description
Class of Compounds	Carcinogen, Zwitterionic, Hydrophobic
Analyzing Compounds	NDMA

N-Nitrosodiethylamine
Valsartan

HPLC Method for Detection of NDEA in Valsartan Drug Substance

Valsartan products are used to treat high blood pressure and congestive heart failure. On July 13, 2018, FDA announced a recall of valsartan tablets because of the potential for certain products to contain an impurity, N-nitrosodimethylamine (NDMA). Nitrosamine impurities is classified as a probable human carcinogen and is believed to have been introduced into the finished products as a result of the manufacturing process of the drug substance. SIELC developed simple and fast HPLC method to measure presence of NDEA in drug formulations. This UV based method allows to detect ppb level of the compound in solution. Simple mobile phase comprised of acetonitrile (MeCN) and water with detection at 232 nm using Newcrom R1 column can be used to detect both the API and the NDEA.

Condition
Column	Newcrom R1, 4.6x150 mm, 5 µm, 100A
Mobile Phase	Gradient MeCN - 10-75%, 12 min
Buffer	H3PO4- 0.1%
Flow Rate	1.0 ml/min
Detection	UV, 232 nm

Description
Class of Compounds	Drug, Carcinogen, Zwitterionic, Hydrophilic, Hydrophobic, Ionizable
Analyzing Compounds	NDEA, Valsartan