N-Nitroso Phenylephrine
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78658-64-7N-Nitroso Phenylephrine

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Catalogue No.:VE0011182
CAS No.:78658-64-7
Mol. Formula:C9H12N2O3
Mol. Weight:196.2 g/mol

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100 mg $129.00
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Additional information on CAS 78658-64-7

Parent drug

Phenylephrine

IUPAC Name

(R)-N-(2-Hydroxy-2-(3-hydroxyphenyl)ethyl)-N-methylnitrous Amide

Pharmacopeial Synonyms

N/A

Synonyms

3-[(1R)-1-hydroxy-2-[methyl(nitroso)amino]ethyl]phenol; Benzenemethanol, 3-hydroxy-a-[(methylnitrosoamino)methyl]-, (R)- (9CI)

Smiles

CN(C[C@@H](C1=CC(=CC=C1)O)O)N=O

InChI

InChI=1S/C9H12N2O3/c1-11(10-14)6-9(13)7-3-2-4-8(12)5-7/h2-5,9,12-13H,6H2,1H3/t9-/m0/s1

FDA Potency Category 2 NDSRI

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

Description

N-Nitroso Phenylephrine (CAS 78658-64-7) is a nitrosamine impurity associated with the secondary amine functionality of phenylephrine-derived structures, arising during nitrosation, oxidative stress, or process contamination from nitrite sources. With formula C9H12N2O3 and molecular weight 196.2 g/mol, it contains an N-nitroso group linked to a chiral aminoalcohol scaffold, a structural alert relevant to genotoxic impurity assessment under ICH M7. Trace determination typically requires highly selective LC-MS/MS, often complemented by high-resolution MS or GC-MS after derivatization, due to low expected concentration and matrix interference.

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