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Mumbai, India

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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.

Mono Nitroso Metoprolol EP Impurity M

● Under Development

Catalogue No.:	VE0027784
CAS No.:	N/A
Mol. Formula:	C9H21N3O2
Mol. Weight:	203.28 g/mol

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Additional information on

Parent drug

Metoprolol

IUPAC Name

N-(2-hydroxy-3-(isopropylamino)propyl)-N-isopropylnitrous amide

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

OC(CNC(C)C)CN(N=O)C(C)C

InChI

InChI=1S/C9H21N3O2/c1-7(2)10-5-9(13)6-12(11-14)8(3)4/h7-10,13H,5-6H2,1-4H3

Description

N-Nitroso Metoprolol EP Impurity M is a nitrosamine-class analytical standard representing a critical low-level impurity observed in metoprolol production and stability studies. As a regulated nitrosamine, it requires trace-level detection and quantification to meet ICH M7 and regional nitrosamine guidance. Characterization employs sensitive techniques such as LC-MS/MS and GC-MS coupled with validated HPLC assays for routine release testing and stability profiling. Laboratories focus on robust sample preparation, limit of detection and quantification validation, and certified reference material for method accuracy. Control strategies prioritize nitrite control, process optimization and stability-indicating methods to ensure compliance and patient safety.