Dexchlorpheniramine EP Impurity B Maleate CAS 23095-76-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.23095-76-3
Molecular FormulaC16H19ClN2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dexchlorpheniramine EP Impurity B Maleate CAS 23095-76-3 chemical structure

Description

The occurrence of Dexchlorpheniramine EP Impurity B Maleate is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Dexchlorpheniramine EP Impurity B Maleate (CAS 23095-76-3) is a certified pharmaceutical impurity reference standard with the molecular formula C16H19ClN2C4H4O4 and a molecular weight of 390.86 g/mol.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Dexchlorpheniramine EP Impurity B Maleate is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 390.86 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC16H19ClN2 C4H4O4
Molecular Weight390.86 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°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.)1963
Halogen ContentCl-containing
Nitrogen Atoms2

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