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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.

Dinitroso Metoprolol EP Impurity M

● Under Development

Catalogue No.:	VE0027788
CAS No.:	N/A
Mol. Formula:	C9H20N4O3
Mol. Weight:	232.28 g/mol

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Additional information on

Parent drug

Metoprolol

IUPAC Name

N,N’-(2-hydroxypropane-1,3-diyl)bis(N-isopropylnitrous amide)

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

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

InChI

InChI=1S/C9H20N4O3/c1-7(2)12(10-15)5-9(14)6-13(11-16)8(3)4/h7-9,14H,5-6H2,1-4H3

Description

Dinitroso Metoprolol EP Impurity M is a characterized process-related impurity detected during Metoprolol manufacture and stability studies, exhibiting distinct chromatographic retention and UV absorbance signatures that facilitate detection by HPLC with PDA and confirmation by LC-MS. Structural analysis suggests a dinitroso substitution arising from nitrosation side reactions under acidic or oxidative conditions, impacting impurity profile and degradation pathways. Comprehensive profiling, quantitation and identification are required for impurity qualification in line with ICH Q3A/Q3B, with limits set by toxicological evaluation. Control strategies focus on reagent selection, process parameter optimization and validated analytical methods for routine release and stability monitoring to maintain product quality.