Ebastine EP Impurity C CAS 58258-01-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.58258-01-8
Molecular FormulaC18H21NO
Molecular Weight267.37 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ebastine EP Impurity C CAS 58258-01-8 chemical structure

Description

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.

Ebastine EP Impurity C (CAS 58258-01-8) is a certified pharmaceutical impurity reference standard with the molecular formula C18H21NO and a molecular weight of 267.37 g/mol.

The molecular framework of Ebastine EP Impurity C (C18H21NO) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

Physical & Chemical Properties

Molecular FormulaC18H21NO
Molecular Weight267.37 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1973
Nitrogen Atoms1

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