Clemastine Impurity 10 Fumarate CAS CATO-C4X-183710

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-183710
Molecular FormulaC21H27NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clemastine Impurity 10 Fumarate CAS CATO-C4X-183710 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.

As a process- or degradation-related impurity, Clemastine Impurity 10 Fumarate (CAS CATO-C4X-183710, C21H27NOC4H4O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Clemastine Impurity 10 Fumarate (C21H27NOC4H4O4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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).

CATO manufactures Clemastine Impurity 10 Fumarate under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC21H27NO C4H4O4
Molecular Weight425.52 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
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

Related Clemastine Standards

Recommended Standards

Why CATO?