Category
Bendamustine
CAS Number
109882-26-0
Alternate CAS Number
109882-27-1(Freebase)
Molecular Formula
C₁₆H₂₂ClN₃O₃·ClH
Molecular Weight
376.28 g/mol
Synonym

5-[(2-chloroethyl)(2-hydroxyethyl)amino]-1-methyl-1H-Benzimidazole-2-butanoic acid hydrochloride ; 4-(5-((2-Chloroethyl)(2-hydroxyethyl)amino)-1-methyl-1H-benzo[d]imidazol-2-yl)butanoic acid hydrochloride ; Bendamustine Monohydroxy Acid Impurity ; Bendamustine USP Related Compound E (HCl); 4-(5-((2-Chloroethyl)(2-hydroxyethyl)amino)-1-methyl-1H-benzo[d]imidazol-2-yl)butanoic acid hydrochloride; 1H-Benzimidazole-2-butanoic acid, 5-[(2-chloroethyl)(2-hydroxyethyl)amino]-1-methyl-, hydrochloride (1:1); 1H-Benzimidazole-2-butanoic acid, 5-[(2-chloroethyl)(2-hydroxyethyl)amino]-1-methyl-, Monohydrochloride; Bendamustine Related Compound E (USP - Base);

Keywords
Impurities
Metabolites.
Pharmaceutical Standards
Fine Chemicals
Impurities manufacturer and Suppliers in Hyderabad india
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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.

Bendamustine monohydroxy acid, an impurity of Bendamustine hydrochloride, is primarily monitored to ensure drug purity and safety in pharmaceutical formulations. It is used in quality control and stability studies to assess degradation pathways during manufacturing and storage.