Description

Bendamustine Impurity 32/2-Hydroxypropyl 4-(5-(Bis(2-Chloroethyl)Amino)-1-Methyl-1H-Benzo[D]Imidazol-2-Yl)Butanoate is a critical process-related impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) bendamustine hydrochloride. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily used in research, development, and quality control processes within the pharmaceutical industry to monitor and control impurity levels during API synthesis.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Bendamustine Impurity 32 in drug substances and products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity profiling of bendamustine.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to ensure API purity meets pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Process Chemistry Research: Used to study and optimize the synthesis pathway of bendamustine to minimize the formation of this impurity.

Basic Information

Product Name	Bendamustine Impurity 32/2-Hydroxypropyl 4-(5-(Bis(2-Chloroethyl)Amino)-1-Methyl-1H-Benzo[D]Imidazol-2-Yl)Butanoate
CAS No.	1219709-88-2
Molecular Formula	C21H30Cl2N4O3
Molecular Weight	457.39 g/mol
Synonyms	Bendamustine Impurity 32; 2-Hydroxypropyl 4-[5-[bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl]butanoate; 2-Hydroxypropyl 4-(5-(Bis(2-Chloroethyl)Amino)-1-Methyl-1H-Benzo[D]Imidazol-2-Yl)Butanoate; Bendamustine Related Compound 32; 1-Methyl-2-[4-[(2-hydroxypropoxy)carbonyl]butyl]-5-[bis(2-chloroethyl)amino]-1H-benzimidazole; Bendamustine EP Impurity G; Bendamustine Hydroxypropyl Ester Impurity
EINECS	Contact for details

Quality Control

Our Bendamustine Impurity 32 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards. Our quality commitment aligns with ICH Q3A/B guidelines and supports cGMP compliance for our clients.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

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

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