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New Jersey, USA
Czech Republic, EU
Mumbai, India

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Enthält: HPLC, MASS/LC-MS, 1H-NMR, FT-IR, Gehalt, Structure Elucidation Report (SER) sowie zusätzliche analytische Daten je nach Produkt.

Mono Nitroso Metoprolol EP Impurity M

● Under Development

Katalog-Nr.::	VE0027784
CAS-Nr.::	N/A
Summenformel::	C9H21N3O2
Molare Masse::	203.28 g/mol

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Zusätzliche Informationen zu

Parent drug

Metoprolol

IUPAC-Name

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

Pharmacopeial Synonyms

N/A

Synonyme

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

Beschreibung

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.