Description

Bendamustine Ether Impurity is a high-purity reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Bendamustine. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of related substances. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of process-related impurities in Bendamustine API.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing of Bendamustine drug substance and drug products to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings (e.g., FDA, EMA).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (forced degradation studies).
• Process Chemistry Research: Aids in the optimization of synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Bendamustine Ether Impurity
CAS No.	1228552-02-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bendamustine Ether Related Compound; Bendamustine Impurity (Ether); Bendamustine Process Impurity; 5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl]methyl ether (probable structure); Bendamustine Alkyl Ether Impurity; Bendamustine API Impurity; Bendamustine Related Substance A (may be applicable); UNII-Contact for details
EINECS	Contact for details

Quality Control

This high-grade impurity standard is manufactured under strict quality control conditions. Each batch is characterized and qualified using advanced analytical techniques including HPLC, GC, MS, and NMR to ensure identity, purity, and traceability. Our quality system is designed to support regulatory requirements, and a comprehensive Certificate of Analysis (COA) with batch-specific data 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 (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Avoid prolonged exposure to air.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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