Epinastine Impurity 10 CAS 41218-84-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.41218-84-2
Molecular FormulaC15H16N2
Molecular Weight224.30 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Epinastine Impurity 10 CAS 41218-84-2 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.

CATO supplies Epinastine Impurity 10 (CAS 41218-84-2), a pharmacopoeial impurity reference standard (molecular formula C15H16N2, MW 224.30 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Epinastine Impurity 10 (C15H16N2) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 224.30 g/mol, it falls into the medium-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC15H16N2
Molecular Weight224.30 g/mol
Purity>95%
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1968
Nitrogen Atoms2

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