Description

Bendamustine Deschloro Dimer Impurity is a critical process-related impurity and degradation product of the antineoplastic agent Bendamustine Hydrochloride. Its identification and control are essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. This impurity is primarily required by pharmaceutical R&D laboratories, quality control units, and regulatory affairs departments for analytical method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Bendamustine Hydrochloride API and its formulations.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/LC-MS methods to monitor impurity profiles.
• Stability and Forced Degradation Studies: Employed to identify and quantify degradation pathways of Bendamustine, supporting regulatory filings (e.g., ICH guidelines Q1A, Q3B).
• Process Chemistry & Impurity Profiling: Used to optimize synthesis routes, establish impurity acceptance criteria, and ensure batch-to-batch consistency.
• Quality Control & Release Testing: Serves as a system suitability standard and for setting specifications in drug substance and drug product release.
• Regulatory Compliance & Submission: Provides necessary data for Investigational New Drug (IND), New Drug Application (NDA), and other global regulatory dossiers.

Basic Information

Product Name	Bendamustine Deschloro Dimer Impurity
CAS No.	1391052-61-1
Molecular Formula	C₂₄H₃₂Cl₂N₄O₄
Molecular Weight	511.44 g/mol
Synonyms	Deschloro Bendamustine Dimer; Bendamustine Dimer Impurity (Deschloro); 5-[[[5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl]carbonyl]amino]-1-methyl-1H-benzimidazole-2-carboxylic acid 2-chloroethyl ester; Bendamustine Related Compound Dimer (Deschloro); SDX-105 Deschloro Dimer Impurity; UNII-Not Assigned; TREANDA Impurity D (Deschloro Dimer)
EINECS	Contact for details

Quality Control

Every batch of Bendamustine Deschloro Dimer Impurity is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using advanced techniques like HPLC, LC-MS, NMR, and IR to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH, USP, and other relevant pharmaceutical guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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