Description

Bendamustine Dihydroxy Impurity is a critical pharmaceutical reference standard used in the analytical profiling of the active pharmaceutical ingredient, Bendamustine Hydrochloride. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by serving as a known marker for quality control testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and validation of Bendamustine-based chemotherapeutic agents.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the dihydroxy impurity in Bendamustine Hydrochloride drug substance and finished products.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods for Bendamustine.
• Stability Studies and Forced Degradation: Employed to monitor the formation of this specific degradant under various stress conditions (e.g., hydrolytic, oxidative) to establish product shelf-life.
• Quality Control and Batch Release Testing: Serves as a system suitability component and an external standard in routine QC assays to ensure every batch meets stringent purity specifications.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research and Development: Used in R&D to study the degradation pathways and chemical behavior of Bendamustine, aiding in formulation optimization.

Basic Information

Product Name	Bendamustine Dihydroxy Impurity
CAS No.	109882-29-3
Molecular Formula	C₁₆H₂₁Cl₂N₃O₃
Molecular Weight	374.26 g/mol
Synonyms	5-[Bis(2-chloroethyl)amino]-1-methyl-2-nitro-1H-benzimidazol-7-ol; Bendamustine Dihydroxy Degradant; Bendamustine Related Compound; Bendamustine Impurity; 1H-Benzimidazole-7-ol, 5-[bis(2-chloroethyl)amino]-1-methyl-2-nitro-; Bendamustine Hydroxy Impurity; Bendamustine Degradation Product
EINECS	Contact for details

Quality Control

Our Bendamustine Dihydroxy Impurity is manufactured under strict quality systems 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 techniques like HPLC, LC-MS, and NMR. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. For long-term storage, consider storing at 2-8°C. 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 matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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