Description

[2H8]-Bendamustine Hydrochloride is a deuterated analog of the established chemotherapeutic agent bendamustine hydrochloride, where eight hydrogen atoms are replaced with the stable isotope deuterium. This isotopic labeling is critical for enhancing pharmacokinetic and metabolic studies, providing a powerful internal standard for precise quantitative analysis via mass spectrometry. It is an essential research tool for pharmaceutical development, clinical research, and forensic toxicology laboratories focused on oncology drug metabolism, bioanalytical method development, and drug-drug interaction studies.

Application

• Internal Standard for LC-MS/MS: Primary application as a high-purity, isotopically labeled internal standard for the accurate quantification of bendamustine and its metabolites in complex biological matrices like plasma, serum, and tissue homogenates.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Enables detailed investigation of absorption, distribution, metabolism, and excretion (ADME) profiles, crucial for preclinical and clinical development stages.
• Bioanalytical Method Development and Validation: Used to develop, optimize, and validate sensitive and specific analytical methods, ensuring regulatory compliance (FDA, EMA) for bioequivalence and therapeutic drug monitoring studies.
• Metabolic Pathway Elucidation: Aids in identifying and characterizing novel metabolites, helping to understand the complete metabolic fate of bendamustine.
• Forensic and Clinical Toxicology: Supports accurate detection and quantification of bendamustine in cases of overdose or for therapeutic drug monitoring in patient care.

Basic Information

Product Name	[2H8]-Bendamustine Hydrochloride
CAS No.	1185068-23-8
Molecular Formula	C16H13D8Cl2N3O2•HCl
Molecular Weight	~426.8 g/mol
Synonyms	Bendamustine-d8 Hydrochloride; Deuterated Bendamustine HCl; 5-[(2-{4-[Bis(2-{2H3}oxyethyl)amino]phenyl}-1H-benzimidazol-1-yl)({2H2})methyl]-1-methyl-1H-1,2,4-triazole-3-carboxylic acid hydrochloride; SDX-105-d8 HCl; LY-357729-d8; Treanda-d8; Ribomustin-d8; Cytostasan-d8; 1H-Benzimidazole-2-butanoic acid, 5-[bis(2-{2H3}oxyethyl)amino]-1-methyl-, 2-{4-[({2H2})chloro({2H2})methyl]phenyl}-, hydrochloride (1:1)
EINECS	Contact for details

Quality Control

Our [2H8]-Bendamustine Hydrochloride is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing key parameters such as isotopic purity (deuterium incorporation), chemical purity by HPLC, and identity confirmation by NMR and MS. We adhere to relevant guidelines for reference standards to support your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This compound is hygroscopic (moisture-sensitive) and light-sensitive; prolonged exposure to ambient conditions should be avoided to maintain stability and purity. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture ingress.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity	≥98 atom % D
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH limits

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