Description

Bendamustine CAS NO 97832-05-8 is a bifunctional alkylating agent belonging to the nitrogen mustard class, designed for targeted therapeutic applications. Its unique structure combines the alkylating properties of mechlorethamine with a purine-like benzimidazole ring, offering a distinct mechanism of action. This compound is essential for pharmaceutical research and development, particularly in the formulation of advanced oncology treatments.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of injectable chemotherapy drugs for the treatment of hematologic malignancies.
• Oncology Research: Critical reference standard and intermediate in preclinical and clinical studies for chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).
• Drug Development: Used in the synthesis and development of novel chemotherapeutic agents and combination therapies.
• Biochemical Research: Employed in studies investigating mechanisms of apoptosis, DNA cross-linking, and resistance pathways in cancer cells.
• GMP Manufacturing: Serves as a key starting material or intermediate in cGMP-compliant production processes for finished dosage forms.

Basic Information

Product Name	Bendamustine
CAS No.	97832-05-8
Molecular Formula	C₁₆H₂₁Cl₂N₃O₂
Molecular Weight	358.26 g/mol
Synonyms	Bendamustine Hydrochloride; SDX-105; Cytostasan; Ribomustin; Treanda; 5-{Bis(2-chloroethyl)amino}-1-methyl-2-benzimidazolebutyric acid; 1-Methyl-5-[bis(2-chloroethyl)amino]-1H-benzimidazole-2-butanoic acid; Bendamustinum
EINECS	Contact for details

Quality Control

Our Bendamustine is manufactured under strict quality systems to ensure it meets the rigorous standards required for pharmaceutical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We adhere to relevant pharmacopeial guidelines (e.g., USP, EP) and can support regulatory filings with full traceability and documentation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C) or as specified. This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions if the container is opened.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥98.0%
Water Content (KF)	≤1.0%
Related Substances (HPLC)	Individual impurity ≤0.5%; Total impurities ≤2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.