Category
Bendamustine
CAS Number
1228551-91-4
Molecular Formula
C₃₂H₄₁Cl₃N₆O₄
Molecular Weight
680.07 g/mol
Synonym

Bendamustine Trichloroethyl Dimer Impurity; Bendamustine Dimer Impurity; 4-[5-({2-[(4-{5-[bis(2-Chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl}butanoyl)oxy]ethyl}(2-chloroethyl)amino)-1-methyl-1H-benzimidazol-2-yl]butanoic Acid; 4-[5-({2-[(4-{5-[Bis(2-chloroethyl)amino]-1-methyl-1H -benzimidazol-2-yl}butanoyl)oxy]ethyl}(2-chloroethyl)amino)-1-methyl-1H -benzimidazol-2-yl]butanoic acid; Bendamustine Related Compound H;Bendamustine Trichloroethyl Dimer Impurity; Bendamustine Dimer Impurity; 4-[5-({2-[(4-{5-[bis(2-Chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl}butanoyl)oxy]ethyl}(2-chloroethyl)amino)-1-methyl-1H-benzimidazol-2-yl]butanoic Acid; 4-[5-({2-[(4-{5-[Bis(2-chloroethyl)amino]-1-methyl-1H -benzimidazol-2-yl}butanoyl)oxy]ethyl}(2-chloroethyl)amino)-1-methyl-1H -benzimidazol-2-yl]butanoic acid; Bendamustine Related Compound H

Keywords
Intermediates
Heterocycles
Impurities
Pharmaceutical Standards
Amines
Fine Chemicals
Impurities manufacturer and Suppliers in Hyderabad india
Slide_1
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 Bendamustine chloro dimer impurity is a process- or degradation-related impurity formed when two molecules of Bendamustine react via their reactive chloroethyl groups, creating a dimeric structure. This impurity is significant in analytical and quality control studies, as it can impact the drug’s stability, potency, and safety, making its detection and quantification essential for regulatory compliance.