Catégorie
Bendamustine
Numéro CAS
109882-26-0
Autre numéro CAS
109882-27-1(Freebase)
Formule moléculaire
C₁₆H₂₃Cl₂N₃O₃
Masse moléculaire
376.28 g/mol
Synonyme

 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); Bendamustine HP-1 Impurity ; 

Mots-clés
Impurities
Fine Chemicals
Metabolites.
Pharmaceutical Standards
Impurities manufacturer and Suppliers in Hyderabad india
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 Impurity, also known Bendamustine HP-1 Impurity, Bendamustine Related Compound E (CAS No. 109882-27-1, Free Base; 109882-26-0, HCl; Molecular Formula: C₁₆H₂₃Cl₂N₃O₃ ; Molecular Weight: 376.28 g/mol), is a recognized degradation impurity of Bendamustine Hydrochloride. It is closely monitored in pharmaceutical formulations to ensure drug purity, quality, and patient safety, and plays a critical role in evaluating degradation pathways during manufacturing, storage, and stability studies. This impurity is widely used as a reference standard in impurity profiling, stability testing, and analytical method development and validation using HPLC and LC–MS techniques for pharmaceutical quality control. Manasa Life Sciences, Hyderabad, India, supplies high-purity Bendamustine Monohydroxy Acid Impurity to pharmaceutical companies, API manufacturers, CROs, and research laboratories worldwide. Manufactured under stringent quality management systems and aligned with ICH, USFDA, EMA, EP, and USP regulatory expectations, the product is provided with comprehensive documentation, including COA, GMP, GDP, MSDS/SDS, and technical data sheets, ensuring complete traceability, regulatory compliance, and reliable performance for research, development, and analytical applications..