Description

Busulfan is a bifunctional alkylating agent belonging to the class of sulfonic acid esters, widely recognized for its potent cytoreductive properties. This high-purity active pharmaceutical ingredient (API) is critical for conditioning regimens prior to hematopoietic stem cell transplantation. It is essential for pharmaceutical manufacturers and research institutions developing advanced oncology and hematology treatments, where consistent quality and reliable supply are paramount.

Application

• Oncological Therapeutics: Primary use as a conditioning agent (myeloablative) prior to allogeneic or autologous hematopoietic progenitor cell transplantation for various leukemias.
• Pharmaceutical Formulation: Serves as the active pharmaceutical ingredient (API) in injectable formulations and high-dose oral tablets.
• Clinical Research: Utilized in investigational studies for new transplant protocols and combination therapies.
• Reference Standard: Used as a certified reference material (CRM) in analytical laboratories for method development and quality control testing.
• Biochemical Research: Employed in studies of alkylating agent mechanisms, DNA cross-linking, and cellular apoptosis pathways.

Basic Information

Product Name	Busulfan
CAS No.	55-98-1
Molecular Formula	C6H14O6S2
Molecular Weight	246.30 g/mol
Synonyms	1,4-Butanediol dimethanesulfonate; Myleran; Tetramethylene bis(methanesulfonate); BSF; Busulfanum; Busulfano; Busulfanum; GT 41; CB 2041; NSC-750
EINECS	200-250-2

Quality Control

Our Busulfan is manufactured under strict quality management systems to meet the rigorous standards required for pharmaceutical applications. Each batch is subjected to comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, in compliance with current pharmacopeial guidelines (e.g., USP, EP). A detailed Certificate of Analysis (COA) documenting purity, related substances, and other critical quality attributes is provided with every shipment to ensure full traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; containers must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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