Description

Bendamustine Bis-Mercapturic Acid-D6 is a stable isotope-labeled analog of a key bendamustine metabolite, specifically designed for use as an internal standard in quantitative bioanalytical studies. This high-purity reference material is critical for ensuring the accuracy and reliability of pharmacokinetic and metabolic profiling data in pharmaceutical research and development. It is an essential tool for analytical chemists and researchers in pharmaceutical companies, contract research organizations (CROs), and academic institutions focused on oncology drug development and bioanalysis.

Application

• Quantitative Bioanalysis: Serves as a deuterated internal standard for the precise quantification of bendamustine and its metabolites in biological matrices (e.g., plasma, serum, urine) using LC-MS/MS and GC-MS techniques.
• Pharmacokinetic (PK) Studies: Enables accurate measurement of drug concentration-time profiles to determine absorption, distribution, metabolism, and excretion (ADME) parameters.
• Metabolite Identification & Profiling: Aids in the structural confirmation and quantification of bendamustine mercapturate pathway metabolites in in vitro and in vivo studies.
• Method Development & Validation: Used as a critical component in developing, optimizing, and validating robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Provides essential standardization for bioanalytical data supporting Phase I-III clinical trials of bendamustine and related compounds.
• Doping Control & Forensic Analysis: Can be utilized as a reference standard in specialized testing for prohibited substances.

Basic Information

Product Name	Bendamustine Bis-Mercapturic Acid-D6
CAS No.	1356930-62-5
Molecular Formula	C₂₄H₂₇D₆N₅O₈S₂
Molecular Weight	Contact for details
Synonyms	Bendamustine D6 Mercapturate; Bendamustine Bis-N-Acetyl-L-cysteine-D6 Adduct; 5-[Bis(2-{[(2R)-2-acetamido-3-[(carboxy-D3)methyl-D3]sulfanylpropanoyl]amino}ethyl)amino]-1-methyl-1H-benzimidazole-2-butanoic acid; Bendamustine Mercapturic Acid Conjugate-D6; Stable Isotope-Labeled Bendamustine Metabolite; Bendamustine-NAC-D6; Internal Standard for Bendamustine Bioanalysis
EINECS	Contact for details

Quality Control

Every batch of Bendamustine Bis-Mercapturic Acid-D6 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for isotopic purity and chemical identity. Certificates of Analysis (COA) detailing batch-specific results for assay, isotopic enrichment, and purity are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dedicated freezer. This compound is hygroscopic (moisture-sensitive); ensure containers are sealed under inert atmosphere or with desiccant to maintain stability and purity. Allow the sealed container to reach room temperature before opening to minimize moisture ingress.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥95%
Isotopic Purity (Deuterium Enrichment)	≥98 atom % D
Water Content (KF)	≤1.0%
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.