Description

Bendamustine-D8 Hydrochloride is a deuterated analog of the established chemotherapeutic agent bendamustine, specifically labeled with eight deuterium atoms. This high-purity compound is essential for advanced pharmacokinetic and metabolic studies, providing critical data for drug development and regulatory submissions. It is primarily utilized by pharmaceutical R&D teams, contract research organizations (CROs), and analytical laboratories engaged in the development and bioanalysis of oncology therapeutics.

Application

• Internal Standard for LC-MS/MS Bioanalysis: Serves as a critical, non-interfering reference compound for the precise quantification of bendamustine and its metabolites in complex biological matrices like plasma and serum.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Enables accurate tracing of the parent drug's absorption, distribution, metabolism, and excretion (ADME) profile in preclinical and clinical research.
• Stable Isotope Labeling in Medicinal Chemistry: Used to investigate metabolic pathways and to synthesize labeled drug conjugates for specialized research applications.
• Quality Control and Method Development: Employed in analytical laboratories to develop, validate, and ensure the accuracy of HPLC and mass spectrometry methods for bendamustine-based products.
• Reference Standard for Regulatory Filings: Provides the definitive standard required for generating compliant data packages for submissions to agencies like the FDA and EMA.

Basic Information

Product Name	Bendamustine-D8 Hydrochloride
CAS No.	1134803-33-0
Molecular Formula	C16H13D8Cl2N3O2•HCl
Molecular Weight	421.77 g/mol (for free base C16H13D8Cl2N3O2)
Synonyms	Bendamustine-d8 HCl; 5-[(2-{4-[Bis(2-{[(2,2,3,3,4,4,5,5-²H8)pentanoyl]amino}ethyl)amino]phenyl}-1H-benzimidazol-1-yl)methyl]-1H-1,2,3-triazol-4-yl)methanol Hydrochloride; 4-{5-[Bis(2-{[(2,2,3,3,4,4,5,5-²H8)pentanoyl]amino}ethyl)amino]-1-methyl-1H-benzimidazol-2-yl}butanoic Acid Hydrochloride (alternative representation); SDX-105-d8 Hydrochloride; Deuterated Bendamustine HCl; Bendamustine (phenyl-d5, propyl-d3) Hydrochloride; Treanda-d8 Hydrochloride; Cytostasan-d8 Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of our Bendamustine-D8 Hydrochloride is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. We guarantee high chemical and isotopic purity verified by advanced techniques including NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific data for identity, purity (HPLC assay), isotopic enrichment, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccant use within the primary container.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum confirms molecular ion and fragmentation pattern
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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