Topiramate EP Impurity D CAS 950603-46-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.950603-46-0
Molecular FormulaC25H39NO15S
Molecular Weight625.64 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Topiramate EP Impurity D CAS 950603-46-0 chemical structure

Description

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.

CATO supplies Topiramate EP Impurity D (CAS 950603-46-0), a pharmacopoeial impurity reference standard (molecular formula C25H39NO15S, MW 625.64 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Topiramate EP Impurity D is typically off-white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 625.64 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC25H39NO15S
Molecular Weight625.64 g/mol
Purity>95%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1987
Nitrogen Atoms1
Sulfur Atoms1

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