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Documentation

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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.

N-Nitroso Metoprolol EP Impurity H

● Under Development

Catalogue No.:	VE0027736
CAS No.:	N/A
Mol. Formula:	C14H22N2O4
Mol. Weight:	282.34 g/mol

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Additional information on

Parent drug

Metoprolol

IUPAC Name

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

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

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

InChI

InChI=1S/C14H22N2O4/c1-11(2)16(15-19)9-13(18)10-20-14-5-3-12(4-6-14)7-8-17/h3-6,11,13,17-18H,7-10H2,1-2H3

Description

N-Nitroso Metoprolol EP Impurity H is a nitrosamine-class impurity observed during metoprolol manufacturing and degradation. As a potential genotoxic impurity it requires strict control through identification of nitrosation pathways, raw material screening, and process parameter optimization. Analytical characterization typically employs sensitive techniques such as GC-MS and LC-MS/MS with validated sample preparation to achieve low ng/g detection limits and quantification limits in compliance with regulatory expectations including ICH M7. Root cause analysis focuses on nitrosating agents, tertiary amine precursors and aqueous acidic conditions. Robust control strategies include reagent selection, scavengers, pH control, and in-process monitoring to mitigate formation risk.