Epinastine Impurity 57 CAS CATO-C4X-184057

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-184057
Molecular FormulaC15H15N3O
Molecular Weight253.30 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Epinastine Impurity 57 CAS CATO-C4X-184057 chemical structure

Description

As a process- or degradation-related impurity, Epinastine Impurity 57 (CAS CATO-C4X-184057, C15H15N3O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Epinastine Impurity 57 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 253.30 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).

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 manufactures Epinastine Impurity 57 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 FormulaC15H15N3O
Molecular Weight253.30 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms3

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