Description

Bendamustine is a bifunctional alkylating agent with a unique benzimidazole ring structure, combining the properties of an alkylator and a purine analog. This dual mechanism of action makes it a critical active pharmaceutical ingredient (API) for the formulation of targeted chemotherapeutic agents. It is primarily required by pharmaceutical manufacturers and research institutions developing treatments for hematological malignancies, such as chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).

Application

• Primary Active Pharmaceutical Ingredient (API) in injectable chemotherapy formulations.
• Key component in the manufacture of lyophilized powder for reconstitution.
• Research and development of novel oncology drug combinations and delivery systems.
• Reference standard for analytical method development and quality control in pharmaceutical labs.
• Pre-clinical studies investigating mechanisms of action and resistance in cancer models.
• Production of generic oncology medications following patent expiry.

Basic Information

Product Name	Bendamustine
CAS No.	16506-27-7
Molecular Formula	C₁₆H₂₁Cl₂N₃O₂
Molecular Weight	358.26 g/mol
Synonyms	Bendamustine Hydrochloride; SDX-105; Cytostasan; Ribomustin; 5-[Bis(2-chloroethyl)amino]-1-methyl-2-benzimidazolebutyric acid; 1-Methyl-5-[bis(2-chloroethyl)amino]-2-benzimidazolebutyric acid; Bendamustin; Bendamustinum
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 high-purity standards suitable for pharmaceutical use. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming identity, purity, and impurity profiles. We adhere to cGMP guidelines to ensure reliable quality and batch-to-batch consistency for our global clientele.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The 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)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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