Description

Bendamustine is a bifunctional alkylating agent belonging to the class of nitrogen mustard derivatives. This compound is of significant commercial and therapeutic importance due to its unique mechanism of action, which combines alkylating and antimetabolite properties. It is primarily required by the pharmaceutical industry for the development and manufacturing of active pharmaceutical ingredients (APIs) used in targeted cancer therapies, particularly for hematological malignancies.

Application

• Pharmaceutical API Synthesis: Primary use as the active pharmaceutical ingredient in injectable formulations for chemotherapy.
• Oncology Drug Manufacturing: Key intermediate in the production of finished dosage forms for the treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL).
• Clinical Research & Development: Serves as a reference standard and building block in preclinical and clinical studies for novel cancer treatment regimens.
• Biopharmaceutical Intermediates: Used in the synthesis of more complex, targeted therapeutic agents and antibody-drug conjugates (ADCs).
• Contract Manufacturing (CMO): Supplied to contract manufacturing organizations for the production of generic and branded oncology medications.
• Regulatory & Quality Control: Employed as a high-purity analytical standard for method validation, stability testing, and regulatory submissions (e.g., FDA, EMA).

Basic Information

Product Name	Bendamustine
CAS No.	1219709-86-0
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; LY-309887
EINECS	Contact for details

Quality Control

Our Bendamustine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. Certificates of Analysis (COA) are provided, detailing results from tests such as HPLC assay, related substances, residual solvents, and heavy metals, in compliance with ICH guidelines and current Good Manufacturing Practice (cGMP) standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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