Description

Bendamustine Impurity 5 is a designated impurity of the antineoplastic agent Bendamustine Hydrochloride, a critical reference standard for analytical and regulatory purposes. This compound is essential for pharmaceutical research and development, enabling the accurate identification, quantification, and control of related substances in active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the global pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards (e.g., USP, EP, ICH).

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Bendamustine Hydrochloride and its related products.
• Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of the API and drug formulations.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity data to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to identify and track potential degradation products.
• Research & Development: Facilitates impurity profiling and characterization during the synthesis process development and scale-up of Bendamustine.

Basic Information

Product Name	Bendamustine Impurity 5
CAS No.	1138238-08-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-{[(2-{4-[Bis(2-chloroethyl)amino]phenyl}-1H-benzimidazol-1-yl)carbonyl]amino}-2-methylbenzoic Acid; Bendamustine Related Compound 5; Bendamustine Impurity C; Bendamustine Hydrochloride Impurity 5; UNII-9V3I8Q2Y1F; 9V3I8Q2Y1F; Benzimidazole-5-carboxamide impurity of Bendamustine
EINECS	Contact for details

Quality Control

Our Bendamustine Impurity 5 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and identity confirmation. Each batch is supplied with a comprehensive Certificate of Analysis (COA) that includes data from orthogonal techniques such as HPLC, MS, and NMR. We support compliance with ICH guidelines and relevant pharmacopeial standards for impurity reference materials.

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 COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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