Busulfan Impurity 11 CAS CATO-C4X-145511

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-145511
Molecular FormulaC12H26O7S2
Molecular Weight346.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Busulfan Impurity 11 CAS CATO-C4X-145511 chemical structure

Description

Busulfan Impurity 11 (CAS CATO-C4X-145511) is a certified pharmaceutical impurity reference standard with the molecular formula C12H26O7S2 and a molecular weight of 346.46 g/mol.

The molecular framework of Busulfan Impurity 11 (C12H26O7S2) is characterized by a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development.

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 FormulaC12H26O7S2
Molecular Weight346.46 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)0.0
Sulfur Atoms2

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