Topiramate Impurity 32 CAS CATO-C4X-176832

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-176832
Molecular FormulaC9H18N2O10S2
Molecular Weight378.38 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Topiramate Impurity 32 CAS CATO-C4X-176832 chemical structure

Description

CATO supplies Topiramate Impurity 32 (CAS CATO-C4X-176832), a pharmacopoeial impurity reference standard (molecular formula C9H18N2O10S2, MW 378.38 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Topiramate Impurity 32 (C9H18N2O10S2) is characterized by a carbohydrate-derived structure, an amide group, a sulfone group. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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), Topiramate Impurity 32 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 FormulaC9H18N2O10S2
Molecular Weight378.38 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
Nitrogen Atoms2
Sulfur Atoms2

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