Description

Bendamustine Bis-Mercapturic Acid is a key metabolite and analytical reference standard of the chemotherapeutic agent bendamustine hydrochloride. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in oncology drug development and regulatory compliance activities.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of bendamustine and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance mechanisms, and excretion profiles of bendamustine.
• Bioanalytical Method Development: Essential for developing and validating sensitive HPLC, LC-MS, or LC-MS/MS assays for clinical trial sample analysis.
• Impurity Profiling and Characterization: Employed as a known impurity or degradation product standard to ensure drug substance and product purity.
• Toxicology and Safety Assessment: Utilized in studies to understand the safety profile and potential toxicities associated with bendamustine metabolism.
• Regulatory Submissions: Provides critical data to support Investigational New Drug (IND) and New Drug Application (NDA) filings with agencies like the FDA and EMA.

Basic Information

Product Name	Bendamustine Bis-Mercapturic Acid
CAS No.	956344-34-6
Molecular Formula	C24H34N4O8S2
Molecular Weight	570.67 g/mol
Synonyms	Bendamustine Dimer; Bendamustine Bis-Mercapturate; 4-[5-[Bis(2-{[(2S)-2-[(carboxymethyl)carbamoyl]-1-(2-hydroxyethyl)-2-sulfanylethyl]carbamoyl}ethyl)amino]-1-methyl-1H-benzimidazol-2-yl]butanoic acid; Bendamustine Mercapturic Acid Dimer; Bendamustine Cysteine Conjugate Dimer
EINECS	Contact for details

Quality Control

Our Bendamustine Bis-Mercapturic Acid is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with relevant guidelines for reference standards. Specifications can be tailored to meet specific pharmacopeial or internal method requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. Allow the container to reach room temperature before opening to minimize moisture condensation. Store in a dry, well-ventilated area away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH limits

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