Epinastine Impurity 28 CAS 532-55-8

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.532-55-8
Molecular FormulaC8H5NOS
Molecular Weight163.20 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Epinastine Impurity 28 CAS 532-55-8 chemical structure

Description

Epinastine Impurity 28 (CAS 532-55-8) is a certified pharmaceutical impurity reference standard with the molecular formula C8H5NOS and a molecular weight of 163.20 g/mol.

Based on its molecular formula C8H5NOS, Epinastine Impurity 28 contains a nitrogen-containing heterocyclic scaffold, an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 163.20 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC8H5NOS
Molecular Weight163.20 g/mol
Purity≥95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Nitrogen Atoms1
Sulfur Atoms1

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