Tiotropium Bromide EP Impurity K CAS CATO-C4X-176411

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-176411
Molecular FormulaC19H19NO5S2
Molecular Weight405.49 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tiotropium Bromide EP Impurity K CAS CATO-C4X-176411 chemical structure

Description

As a process- or degradation-related impurity, Tiotropium Bromide EP Impurity K (CAS CATO-C4X-176411, C19H19NO5S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Tiotropium Bromide EP Impurity K (C19H19NO5S2) contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 405.49 g/mol, it falls into the moderately-high-molecular-weight range. 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).

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), Tiotropium Bromide EP Impurity K 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 FormulaC19H19NO5S2
Molecular Weight405.49 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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1
Sulfur Atoms2

Related Tiotropium Standards

Recommended Standards

Why CATO?