Description

Bendamustine Desmethyl Impurity is a key pharmaceutical reference standard and impurity used in the research, development, and quality control of the anticancer drug Bendamustine Hydrochloride. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in oncology drug production and compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of the desmethyl impurity in Bendamustine Hydrochloride active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating high-performance liquid chromatography (HPLC), UPLC, and mass spectrometry methods.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure drug substance and product specifications are met per ICH guidelines.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA).
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Bendamustine to minimize the formation of this impurity.

Basic Information

Product Name	Bendamustine Desmethyl Impurity
CAS No.	41515-13-3
Molecular Formula	C₁₅H₂₁Cl₂N₃O₂
Molecular Weight	346.25 g/mol
Synonyms	Desmethyl Bendamustine; 5-[(1-Methyl-2-{[(2-{[(2-chloroethyl)amino]carbonyl}phenyl)amino]carbonyl}ethyl)amino]-1H-benzimidazol-2-yl carbamic acid tert-butyl ester (IUPAC); Bendamustine Impurity D; Bendamustine Related Compound D; Bendamustine N-Desmethyl Impurity; LY 357729 Desmethyl Impurity; SDX-105 Desmethyl Impurity; Treanda Impurity D
EINECS	Contact for details

Quality Control

Our Bendamustine Desmethyl Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. It is characterized and qualified using advanced techniques including HPLC, GC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles. The product is suitable for use under current Good Manufacturing Practice (cGMP) and ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	98.0% - 102.0%

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