Category
Nintedanib
CAS Number
1168150-46-6
Molecular Formula
C18H15NO4
Molecular Weight
309.3 g/mol
Synonym

Methyl (E)-3-(methoxy(phenyl)methylene)-2-oxoindoline-6-carboxylate;(3E)-2,3-Dihydro-3-(methoxyphenylmethylene)-2-oxo-1H-Indole-6-carboxylic Acid Methyl Ester;Methyl (E)-3-(methoxy(phenyl)methylene)-2-oxoindoline-6-carboxylate;

Keywords
Pharmaceutical Standards
Impurities
Intermediates
Metabolites.
Fine Chemicals
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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Nintedanib Impurity 3 is employed as a reference standard in pharmaceutical analysis to detect, identify, and quantify related impurities formed during the synthesis or degradation of nintedanib. It supports impurity profiling, stability studies, and analytical method validation to ensure product quality and regulatory compliance.