Description

Bendamustine Hydrochloride CAS NO 3543-75-7 is a nitrogen mustard derivative and a bifunctional alkylating agent used as a potent antineoplastic pharmaceutical active ingredient. Its primary value lies in its unique mechanism of action, which combines alkylating properties with antimetabolite-like activity, making it effective against certain resistant cell lines. This compound is critically needed by pharmaceutical manufacturers and research institutions for the formulation of injectable chemotherapy drugs, primarily indicated for the treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).

Application

• Active Pharmaceutical Ingredient (API) in the commercial manufacture of injectable oncology drugs.
• Key component in chemotherapy formulations for treating Chronic Lymphocytic Leukemia (CLL).
• Essential raw material for drugs targeting B-cell Non-Hodgkin's Lymphoma (NHL).
• Used in clinical research and development of new antineoplastic therapies.
• Reference standard in analytical laboratories for quality control and method validation.
• Intermediate in the synthesis of novel, targeted cancer therapeutics under investigation.

Basic Information

Product Name	Bendamustine Hydrochloride
CAS No.	3543-75-7
Molecular Formula	C₁₆H₂₁Cl₂N₃O₂•HCl
Molecular Weight	394.72 g/mol
Synonyms	Bendamustine HCl; Cytostasan Hydrochloride; SDX-105; 5-[Bis(2-chloroethyl)amino]-1-methyl-2-benzimidazolebutyric acid hydrochloride; 1H-Benzimidazole-1-butanoic acid, 5-[bis(2-chloroethyl)amino]-1-methyl-, hydrochloride (1:1); Treanda (brand name formulation); Levact (brand name formulation); Ribomustin (brand name formulation)
EINECS	Contact for details

Quality Control

Our Bendamustine Hydrochloride is manufactured under strict quality systems designed for pharmaceutical actives. We adhere to current Good Manufacturing Practices (cGMP) and our quality protocols are designed to meet or exceed relevant pharmacopeial standards (e.g., USP, EP). All batches undergo comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis. A detailed Certificate of Analysis (COA) documenting purity, related substances, and other critical parameters is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term stability, storage under an inert atmosphere is recommended.

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% - 102.0% (on anhydrous basis)
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
Specific Rotation	Contact for details
pH (in solution)	Contact for details

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