Category
Bendamustine
CAS Number
1313020-25-5
Molecular Formula
C₁₉H₂₇Cl₂N₃O₂
Molecular Weight
400.34 g/mol
Synonym

5-[Bis(2-chloroethyl)-amino]-1-methyl-1H-benzimidazole-2-butanoic Acid Isopropyl Ester ; Isopropyl 4-(5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl)butanoate ; 4-[5-[Bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic Acid Isopropyl Ester ; 1-Methylethyl 5-[bis(2-chloroethyl)amino]-1-methyl-1H-Benzimidazole-2-butanoate ; Bendamustine Isopropyl Ester ; Bendamustine Impurity C

Keywords
Impurities
Pharmaceutical Standards
Intermediates
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 isopropyl ester impurity is used in analytical and quality control studies to detect and quantify minor process- or degradation-related products in Bendamustine formulations. It also supports stability testing and regulatory compliance, ensuring the drug’s purity, safety, and efficacy.