Topiramate Impurity 41 CAS CATO-C4X-176841

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Topiramate Impurity 41.

As a process- or degradation-related impurity, Topiramate Impurity 41 (CAS CATO-C4X-176841, C9H18N2O10S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C9H18N2O10S2, Topiramate Impurity 41 contains a carbohydrate-derived structure, an amide group, a sulfone group; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 378.38 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 41 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

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