Busulfan Impurity 16 CAS CATO-C4X-145516

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-145516
Molecular FormulaC7H16O4S
Molecular Weight196.26 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Busulfan Impurity 16 CAS CATO-C4X-145516 chemical structure

Description

The occurrence of Busulfan Impurity 16 is closely related to a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Busulfan Impurity 16 (CAS CATO-C4X-145516, C7H16O4S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Busulfan Impurity 16 (C7H16O4S) 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.

As a certified reference material (CRM), Busulfan Impurity 16 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC7H16O4S
Molecular Weight196.26 g/mol
Purity>95%
StorageStore at 2-8°C, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)0.0
Sulfur Atoms1

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