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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 Eltrombopag Impurity 1

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Catalogue No.:	VE0010235
CAS No.:	N/A
Mol. Formula:	C12H13N3O2
Mol. Weight:	231.25 g/mol

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Additional information on N-Nitroso Eltrombopag Impurity 1

Parent drug

Eltrombopag

IUPAC Name

2-(3,4-dimethylphenyl)-5-methyl-1-nitroso-1H-pyrazol-3(2H)-one

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

O=C1N(C2=CC=C(C)C(C)=C2)N(N=O)C(C)=C1

InChI

InChI=1S/C12H13N3O2/c1-8-4-5-11(6-9(8)2)14-12(16)7-10(3)15(14)13-17/h4-7H,1-3H3

Description

N-Nitroso Eltrombopag Impurity 1 is a nitrosamine-related degradant of eltrombopag, structurally defined by N-nitrosation of the parent heteroaromatic amine motif. With molecular formula C12H13N3O2 and molecular weight 231.25 g/mol, it represents a potentially genotoxic process- or storage-derived impurity arising under nitrosating conditions, especially in the presence of secondary amine precursors and reactive nitrite species. Such entities are evaluated within the regulatory framework for nitrosamine impurities and ICH M7 principles. Trace determination typically requires LC-MS/MS with high-resolution MS confirmation, and, where volatility permits, GC-MS for orthogonal characterization.