Busulfan impurity dimer CAS CATO-C4X-145524

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-145524
Molecular FormulaC8H18O7S2
Molecular Weight290.35 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Busulfan impurity dimer CAS CATO-C4X-145524 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Busulfan impurity dimer.

As a process- or degradation-related impurity, Busulfan impurity dimer (CAS CATO-C4X-145524, C8H18O7S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a carbohydrate-derived structure, a sulfone group, Busulfan impurity dimer is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 290.35 g/mol — guide the selection of appropriate sample preparation and analytical techniques.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC8H18O7S2
Molecular Weight290.35 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)0.0
Sulfur Atoms2

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