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2820170-76-9N-Nitroso Bisoprolol

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Catalogue No.:	VE007662
CAS No.:	2820170-76-9
Mol. Formula:	C18H30N2O5
Mol. Weight:	354.44 g/mol

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Additional information on CAS 2820170-76-9

Parent drug

Bisoprolol

IUPAC Name

N-(2-hydroxy-3-(4-((2-isopropoxyethoxy)methyl)phenoxy)propyl)-N-isopropylnitrous amide

Pharmacopeial Synonyms

N/A

Synonyms

1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)nitrosoamino]-2-propanol;2-Propanol, 1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)nitrosoamino]

Smiles

O=NN(CC(O)COC1=CC=C(COCCOC(C)C)C=C1)C(C)C

InChI

InChI=1S/C18H30N2O5/c1-14(2)20(19-22)11-17(21)13-25-18-7-5-16(6-8-18)12-23-9-10-24-15(3)4/h5-8,14-15,17,21H,9-13H2,1-4H3

FDA Potency Category 4 NDSRI

1500 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-bisoprolol (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.

Description

N-Nitroso-Bisoprolol (CAS 2820170-76-9) is a nitrosamine impurity derived from bisoprolol, structurally characterized by N-nitrosation of the tert-alkylamino moiety to give the molecular formula C18H30N2O5 and molecular weight 354.44 g/mol. As with related N-nitrosamines, formation is typically associated with nitrosating conditions during synthesis, workup, or storage in the presence of secondary or tertiary amine precursors and nitrite sources. This class is treated as a potential genotoxic impurity under ICH M7 and related nitrosamine risk frameworks. Trace-level assignment commonly requires LC-MS/MS, high-resolution LC-MS, and confirmatory GC-MS, with control based on sub-ppm sensitivity and orthogonal structural elucidation.