Description

Bendamustine Impurity 13/Ethyl 4-(5-((2-Hydroxyethyl)Amino)-1-Methyl-1H-Benzo[D]Imidazol-2-Yl)Butanoate is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and analytical profiling of the active pharmaceutical ingredient (API) Bendamustine, ensuring drug safety and efficacy. It is essential for analytical chemists, quality assurance professionals, and researchers in pharmaceutical manufacturing and regulatory compliance sectors who require reliable standards for method development, validation, and impurity monitoring.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Bendamustine Impurity 13 in drug substance and finished product analysis.
• Analytical Method Development & Validation: A critical component for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Research on Degradation Pathways: Facilitates studies into the chemical stability and degradation mechanisms of Bendamustine.

Basic Information

Product Name	Bendamustine Impurity 13/Ethyl 4-(5-((2-Hydroxyethyl)Amino)-1-Methyl-1H-Benzo[D]Imidazol-2-Yl)Butanoate
CAS No.	1366085-72-4
Molecular Formula	C18H26N4O3
Molecular Weight	346.43 g/mol
Synonyms	Bendamustine Impurity 13; Ethyl 4-[5-[(2-hydroxyethyl)amino]-1-methyl-1H-benzimidazol-2-yl]butanoate; 1H-Benzimidazole-2-butanoic acid, 5-[(2-hydroxyethyl)amino]-1-methyl-, ethyl ester; Bendamustine Related Compound 13; Bendamustine EP Impurity J; Bendamustine Hydrochloride Impurity 13; 1366085-72-4; Ethyl 4-(5-((2-Hydroxyethyl)amino)-1-methyl-1H-benzo[d]imidazol-2-yl)butanoate
EINECS	Contact for details

Quality Control

Our Bendamustine Impurity 13 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, impurity profile, and analytical data, supporting compliance with cGMP and ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, the container must be kept tightly sealed in a cool, dry place to prevent degradation and absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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