Category
Nintedanib
CAS Number
1174335-83-1
Molecular Formula
C20H16ClNO5
Molecular Weight
385.8 g/mol
Synonym

 Methyl (E)-1-(2-chloroacetyl)-3-(methoxy(phenyl)methylene)-2-oxoindoline-6-carboxylate;Methyl (3E)-1-(2-chloroacetyl)-3-[methoxy(phenyl)methylidene]-2-oxo-2,3-dihydro-1H-indole-6-carboxylate;

Keywords
Impurities
Metabolites.
Pharmaceutical Standards
Intermediates
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 2 is used as a reference standard in pharmaceutical quality control to identify and quantify process- or degradation-related impurities during nintedanib synthesis and storage. It aids impurity profiling, method validation, and regulatory compliance to ensure the safety and quality of nintedanib products.