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1116-54-7N-Nitrosodiethanolamine (NDIEA)

● Under Development

Catalogue No.:	VE006105
CAS No.:	1116-54-7
Mol. Formula:	C4H10N2O3
Mol. Weight:	134.13 g/mol

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Additional information on CAS 1116-54-7

Parent drug

Nitroso inhouse impurity

IUPAC Name

Nitrosobis(2-hydroxyethyl)amine

Smiles

C(CO)N(CCO)N=O

InChI

InChI=1S/C4H10N2O3/c7-3-1-6(5-9)2-4-8/h7-8H,1-4H2

FDA Potency Category 1 NDSRI

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

Pharmacopoeial Synonyms

N/A

Other Synonyms

N,N-bis(2-hydroxyethyl)nitrous amide; Nitrosoimino diethanol; Ethanol, 2,2′-(nitrosoimino)bis-; Diethylamine, 2,2′-dihydroxy-N-nitroso-

Shipping Condition

Ambient Temperature

Description

N-Nitrosodiethanolamine (NDIEA), CAS 1116-54-7, is a low-molecular-weight nitrosamine impurity of molecular formula C4H10N2O3 and molecular weight 134.13 g/mol. This compound is structurally consistent with nitrosative conversion of diethanolamine under conditions involving nitrite, acidic media, or process contamination. As a member of the N-nitrosamine class, it is treated as a potentially genotoxic impurity within modern regulatory frameworks, including ICH M7 risk assessment. Quantification typically requires highly selective LC-MS/MS or GC-MS methods, often with isotopically labeled internal standards, because trace-level determination is challenged by volatility, matrix effects, and background contamination.

References

Fan, T. Y., Goff, U., Song, L., Fine, D. H., Arsenault, G. P., & Biemann, K. (1977). N-Nitrosodiethanolamine in cosmetics, lotions and shampoos. Food and Cosmetics Toxicology, 15(5), 423?430. https://doi.org/10.1016/s0015-6264(77)80007-2 ?