Description

Bendamustine Hydrochloride Monohydrate is a nitrogen mustard derivative and bifunctional alkylating agent used as a key active pharmaceutical ingredient (API). This compound is critical for the formulation of targeted chemotherapeutic treatments, offering a distinct mechanism of action for improved therapeutic profiles. It is primarily required by pharmaceutical manufacturers and research institutions developing oncology drugs, particularly for hematologic malignancies such as chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).

Application

• Primary Active Pharmaceutical Ingredient (API) in injectable oncology formulations.
• Research and development of novel chemotherapeutic agents and combination therapies.
• Manufacturing of finished dosage forms under current Good Manufacturing Practice (cGMP) standards.
• Reference standard for analytical method development and quality control in pharmaceutical laboratories.
• Pre-clinical and clinical trial material for investigating new cancer treatment protocols.

Basic Information

Item	Details
Product Name	Bendamustine Hydrochloride Monohydrate
CAS No.	1374784-02-7
Molecular Formula	C₁₆H₂₁Cl₂N₃O₂ • HCl • H₂O
Molecular Weight	394.73 g/mol
Synonyms	Bendamustine HCl Monohydrate; 5-[Bis(2-chloroethyl)amino]-1-methyl-2-benzimidazolebutyric acid hydrochloride monohydrate; SDX-105; Treanda (brand name reference); Cytostasan; Ribomustin; 1H-Benzimidazole-1-butanoic acid, 5-[bis(2-chloroethyl)amino]-2-methyl-, hydrochloride, monohydrate
EINECS	Contact for details

Quality Control

Our Bendamustine Hydrochloride Monohydrate is manufactured and tested to meet stringent pharmaceutical-grade specifications. Quality assurance protocols align with ICH guidelines, and the product is typically characterized against relevant pharmacopeial standards (e.g., USP monographs). A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results for identity, purity, assay, and specified impurities. Our quality system ensures traceability and compliance for global regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as specified on the label. The product is hygroscopic (moisture-sensitive) and must be protected from humidity. For long-term storage, consider desiccants or inert atmosphere conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	3.5% - 5.5%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 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.