Description

Busulfan Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Busulfan through rigorous impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The availability of this well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Busulfan Impurity 1 in Busulfan drug substance and finished products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods for Busulfan.
• Quality Control and Batch Release: Serves as a system suitability and identification standard in the routine QC testing of Busulfan to ensure compliance with ICH guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed to monitor the formation and level of this specific impurity during forced degradation and long-term stability studies of Busulfan formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to establish impurity thresholds and justify specifications.
• Research and Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the profile and impact of impurities.

Basic Information

Product Name	Busulfan Impurity 1
CAS No.	1797106-48-9
Molecular Formula	C6H14O6S2
Molecular Weight	246.30 g/mol
Synonyms	1,4-Bis(methanesulfonoxy)butane Impurity; Busulfan Related Compound 1; 1,4-Butanediol dimethanesulfonate impurity; Tetramethylene dimethanesulfonate impurity; Butane-1,4-diyl bis(methanesulfonate); Methanesulfonic acid, 1,4-butanediyl ester; 1,4-Bis(methylsulfonyloxy)butane
EINECS	Contact for details

Quality Control

Our Busulfan Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents in accordance with ICH Q3 guidelines. A detailed Certificate of Analysis (COA) is provided with each shipment, which includes batch-specific data, chromatograms, and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C. The container should be kept in a well-ventilated area and handled with appropriate personal protective equipment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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