Description

Bendamustine Impurity C is a specified organic impurity associated with the active pharmaceutical ingredient Bendamustine Hydrochloride. This compound is critical for pharmaceutical research, development, and quality control, serving as a key reference standard for analytical method validation and impurity profiling. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical reference materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bendamustine Hydrochloride drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the manufacturing process.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Bendamustine batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Bendamustine formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the drug's impurity profile.
• Research on Degradation Pathways: Aids in studying the chemical degradation mechanisms of Bendamustine under various stress conditions.

Basic Information

Product Name	Bendamustine Impurity C
CAS No.	1313020-25-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bendamustine Related Compound C; Bendamustine Impurity 3; 5-[5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl]-2-fluorobenzoic Acid (proposed); Bendamustine Degradation Product; Bendamustine Process Impurity; API Impurity of Bendamustine; Treanda Impurity C; Levact Impurity C
EINECS	Contact for details

Quality Control

Our Bendamustine Impurity C is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic (HPLC/UPLC) and spectroscopic (MS, NMR) techniques. We adhere to relevant ICH guidelines and support compliance with cGMP standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C. The material should be kept in a dry environment. For long-term storage, consider conditions recommended for light-sensitive and potentially hygroscopic pharmaceutical compounds.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum consistent with structure
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)	≤ 5.0% w/w

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