Tiotropium impurity 48 CAS CATO-C4X-176448

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-176448
Molecular FormulaC16H21NO4
Molecular Weight291.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tiotropium impurity 48 CAS CATO-C4X-176448 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 291.34 g/mol gives Tiotropium impurity 48 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Tiotropium impurity 48 (CAS CATO-C4X-176448, C16H21NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Tiotropium impurity 48 (C16H21NO4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Tiotropium impurity 48 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 FormulaC16H21NO4
Molecular Weight291.34 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, 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
Nitrogen Atoms1

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