Topiramate Impurity 36 CAS 455899-78-2

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.455899-78-2
Molecular FormulaC12H20O9S
Molecular Weight340.35 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Topiramate Impurity 36 CAS 455899-78-2 chemical structure

Description

Owing to a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, Topiramate Impurity 36 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 340.35 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

As a process- or degradation-related impurity, Topiramate Impurity 36 (CAS 455899-78-2, C12H20O9S) 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.

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 FormulaC12H20O9S
Molecular Weight340.35 g/mol
Purity>90%
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)2025
Sulfur Atoms1

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