Description

Bendamustine Impurity 16 is a designated impurity of the antineoplastic agent Bendamustine Hydrochloride, identified by CAS NO 914626-65-6. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this specific impurity during drug substance and product manufacturing. It is an essential material for analytical method development and validation, stability studies, and regulatory compliance submissions within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Bendamustine Hydrochloride.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing and validating stability-indicating methods to separate and quantify Bendamustine Impurity 16 from the active pharmaceutical ingredient (API) and other related substances.
• Quality Control & Batch Release Testing: Used in pharmaceutical QC laboratories to ensure drug substance and drug product batches meet stringent impurity profile specifications as per ICH guidelines.
• Stability Studies & Forced Degradation: Employed to identify and track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Documentation: Supports the preparation of regulatory filings (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Bendamustine, supporting formulation optimization.

Basic Information

Product Name	Bendamustine Impurity 16
CAS No.	914626-65-6
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}-1H-benzimidazol-2-amine; Bendamustine Related Compound 16; Bendamustine Impurity J; Bendamustine Degradant; UNII-8K3V7B3K1F; 8K3V7B3K1F
EINECS	Contact for details

Quality Control

Our Bendamustine Impurity 16 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods, including HPLC purity, related substances, and structural confirmation. We support compliance with ICH Q3A, Q3B, and Q6A guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.