Category
Bendamustine
CAS Number
109882-30-6
Alternate CAS Number
109882-29-3(HCl Salt)
Molecular Formula
C₁₆H₂₃N₃O₄
Molecular Weight
321.37 g/mol
Synonym

5-[Bis(2-hydroxyethyl)amino]-1-methyl-1H-benzimidazole-2-butanoic Acid; 4-(5-(Bis(2-hydroxyethyl)amino)-1-methyl-1H-benzo[d]imidazol-2-yl)butanoic Acid; 4-{5-[bis(2-Hydroxyethyl)amino]-1-methyl-1H-benzimidazol-2-yl}butanoic Acid Hydrochloride; 4-{5-[Bis(2-hydroxyethyl)amino]-1-methyl-1H -benzimidazol-2-yl}butanoic acid; Bendamustine Related Compound A (USP);

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.

Bendamustine dihydroxy impurity is a degradation product of Bendamustine formed when the active drug undergoes hydrolysis, often during storage or in aqueous solutions. It can affect the stability, potency, and safety of the pharmaceutical formulation, making its identification and control critical in quality assessments.