Topiramate Impurity 9 CAS 58238-46-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.58238-46-3
Molecular FormulaC9H16O6
Molecular Weight220.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Topiramate Impurity 9 CAS 58238-46-3 chemical structure

Description

Based on its molecular formula C9H16O6, Topiramate Impurity 9 contains a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 220.22 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry.

As a process- or degradation-related impurity, Topiramate Impurity 9 (CAS 58238-46-3, C9H16O6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical 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), Topiramate Impurity 9 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 FormulaC9H16O6
Molecular Weight220.22 g/mol
Purity>95%
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)2.0
CAS Registry Year (est.)1973

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