Bepotastine Impurity 4 CAS 210095-58-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.210095-58-2
Molecular FormulaC17H19ClN2O
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bepotastine Impurity 4 CAS 210095-58-2 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Bepotastine Impurity 4.

Bepotastine Impurity 4 (CAS 210095-58-2) is a certified pharmaceutical impurity reference standard with the molecular formula C17H19ClN2OC4H6O6 and a molecular weight of 452.89 g/mol.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Bepotastine Impurity 4 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 452.89 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 Bepotastine Impurity 4 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 FormulaC17H19ClN2O C4H6O6
Molecular Weight452.89 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2017
Halogen ContentCl-containing
Nitrogen Atoms2

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