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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

55-18-5N-Nitrosodiethylamine (NDEA)

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Catalogue No.:	VL3850024
CAS No.:	55-18-5
Mol. Formula:	C4H10N2O
Mol. Weight:	102.14 g/mol

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Additional information on CAS 55-18-5

Parent drug

Irbesartan/ Losartan/ Valsartan

IUPAC Name

Diethylnitrosamine

Pharmacopeial Synonyms

N/A

Synonyms

N,N-diethylnitrous amide; N,N-Diethylnitrosamine; Ethanamine, N-ethyl-N-nitroso-; N-Ethyl-N-nitroso-ethanamine

Smiles

CCN(CC)N=O

InChI

InChI=1S/C4H10N2O/c1-3-6(4-2)5-7/h3-4H2,1-2H3

Shipping Condition

Ambient Temperature

FDA Potency Category Compound‑specific NDSRI

26.5 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N‑Nitrosodiethylamine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.

Description

N-Nitroso Diethylamine (NDEA), CAS 55-18-5, is a low-molecular-weight nitrosamine impurity with the formula C4H10N2O and molecular weight 102.14 g/mol. It is commonly associated with secondary amine nitrosation during synthesis, solvent contamination, or oxidative degradation pathways, and is regarded as a potent genotoxic impurity. In pharmaceutical risk assessment, NDEA is evaluated under ICH M7 principles and related nitrosamine control expectations because of its carcinogenic concern. Determination generally requires highly selective methods such as GC-MS, GC-MS/MS, or LC-MS/MS, often with isotopically labeled internal standards to achieve sub-ppb quantification and confirmatory identification.