Description

Busulfan-D8 is a deuterated analog of the alkylating antineoplastic agent Busulfan, specifically labeled with eight deuterium atoms. This stable isotope-labeled compound is an essential internal standard for the precise and accurate quantification of Busulfan in biological matrices using advanced analytical techniques like LC-MS/MS. It is a critical tool for pharmaceutical research, clinical laboratories, and contract research organizations (CROs) engaged in pharmacokinetic studies, therapeutic drug monitoring, and bioanalytical method development and validation.

Application

• Internal Standard for Bioanalysis: Primary use as a stable isotope-labeled internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the quantification of Busulfan in plasma, serum, and other biological samples.
• Pharmacokinetic and Toxicokinetic Studies: Enables precise measurement of drug concentration-time profiles, essential for determining key parameters like clearance, half-life, and volume of distribution in preclinical and clinical research.
• Therapeutic Drug Monitoring (TDM): Supports accurate TDM protocols for patients undergoing high-dose Busulfan conditioning regimens prior to hematopoietic stem cell transplantation, helping to individualize dosing and minimize toxicity.
• Bioanalytical Method Development: Used in the development, validation, and quality control of robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Metabolism Studies: Aids in investigating the metabolic pathways and stability of Busulfan in vitro and in vivo.
• Reference Material for Quality Control: Serves as a high-purity certified reference material for calibrating instruments and ensuring data integrity in analytical laboratories.

Basic Information

Product Name	Busulfan-D8
CAS No.	116653-28-2
Molecular Formula	C6H6D8O6S2
Molecular Weight	186.27 g/mol (deuterated form)
Synonyms	1,4-Bis(methanesulfonoxy)butane-D8; Tetramethylene bis(methanesulfonate)-D8; BSF-D8; Myleran-D8; Butanediol dimethanesulfonate-D8; 1,4-Butanediol dimethanesulfonate-D8; Deuterated Busulfan; [2H8]-Busulfan
EINECS	Contact for details

Quality Control

Our Busulfan-D8 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical integrity, suitable for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic enrichment, chemical purity, and absence of interfering impurities. We support research and development that adheres to GLP (Good Laboratory Practice) and relevant regulatory guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container sealed in a dry and well-ventilated place. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
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.