Description

Bendamustine Impurity 25/1-Hydroxypropan-2-Yl 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, 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 validate analytical methods and monitor impurity levels during drug production.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Bendamustine Impurity 25 in drug substance and drug product testing.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to ensure Bendamustine HCl meets stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to monitor the formation and growth of this specific impurity under various stress conditions to determine drug shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Used by R&D scientists to understand and optimize the synthesis pathway of Bendamustine to minimize the formation of this impurity.

Basic Information

Product Name	Bendamustine Impurity 25/1-Hydroxypropan-2-Yl 4-(5-(Bis(2-Chloroethyl)Amino)-1-Methyl-1H-Benzo[D]Imidazol-2-Yl)Butanoate
CAS No.	1219709-89-3
Molecular Formula	C21H30Cl2N4O3
Molecular Weight	457.39 g/mol
Synonyms	Bendamustine Impurity 25; 1-Hydroxypropan-2-yl 4-[5-[bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl]butanoate; Bendamustine Related Compound 25; 2-Hydroxypropyl 4-(5-(bis(2-chloroethyl)amino)-1-methyl-1H-benzo[d]imidazol-2-yl)butanoate; Isopropyl Alcohol Ester of Bendamustine Acid; Bendamustine Isopropyl Ester Impurity; 1-Methyl-2-[4-[(1-methylethoxy)carbonyl]butyl]-5-[bis(2-chloroethyl)amino]-1H-benzimidazole
EINECS	Contact for details

Quality Control

Our Bendamustine Impurity 25 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data, including batch-specific results for purity and related substances, are provided to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is moisture-sensitive; keep the container in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

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

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