Epinastine Impurity 43 CAS 41218-85-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.41218-85-3
Molecular FormulaC16H16N2
Molecular Weight236.31 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Epinastine Impurity 43 CAS 41218-85-3 chemical structure

Description

CATO supplies Epinastine Impurity 43 (CAS 41218-85-3), a pharmacopoeial impurity reference standard (molecular formula C16H16N2, MW 236.31 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Epinastine Impurity 43 (C16H16N2) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 236.31 g/mol, it falls into the medium-molecular-weight range. 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.

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 FormulaC16H16N2
Molecular Weight236.31 g/mol
Purity97%+
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1968
Nitrogen Atoms2

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