Description

Bendamustine Impurity 9 is a specified impurity and degradation product of the antineoplastic agent Bendamustine Hydrochloride. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation. It is primarily used by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Bendamustine drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bendamustine Hydrochloride active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine batch testing to ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines) for impurity limits.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Bendamustine Impurity 9
CAS No.	1869075-90-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bendamustine Related Compound 9; Bendamustine Degradant 9; Bendamustine Process Impurity 9; 4-[5-[Bis(2-chloroethyl)amino]-1-methyl-2-benzimidazolyl]butanoic acid (putative); Bendamustine Hydrochloride Impurity 9; Bendamustine Impurity C (potential designation); Bendamustine Specified Impurity
EINECS	Contact for details

Quality Control

Our Bendamustine Impurity 9 is manufactured under strict quality systems. Each batch is characterized and tested using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure high purity and structural identity. Certificates of Analysis (COA) are provided, detailing purity, chromatographic data, and batch-specific results. Our quality commitment aligns with ICH guidelines for impurity reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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