Category
Binimetinib
CAS Number
NA
Molecular Formula
C₂₁H₂₂BrF₂N₅O₄
Molecular Weight
526.33 g/mol
Synonym

5-((4-bromo-2-fluorophenyl)(nitroso)amino)-N-(2-(tert-butoxy)ethoxy)-4-fluoro-1-methyl-1H-benzo[d]imidazole-6-carboxamide ; Binimetinib Tertiary Amide Nitroso Impurity;

Keywords
Fine Chemicals
Metabolites.
Impurities manufacturer and Suppliers in Hyderabad india
Aromatics
Amines
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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.

The Binimetinib Tertiary Amide Nitroso Impurity is primarily monitored in pharmaceutical manufacturing to ensure the safety and quality of the final drug product. It is used in analytical studies for impurity profiling, helping detect and quantify trace nitroso compounds in binimetinib batches, and plays a key role in regulatory compliance by ensuring adherence to safety guidelines for potential genotoxic impurities.