Bilastine Impurity 19 CAS 202189-81-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.202189-81-9
Molecular FormulaC28H36N4O
Molecular Weight444.61 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bilastine Impurity 19 CAS 202189-81-9 chemical structure

Description

CATO supplies Bilastine Impurity 19 (CAS 202189-81-9), a pharmacopoeial impurity reference standard (molecular formula C28H36N4O, MW 444.61 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C28H36N4O, Bilastine Impurity 19 contains a steroid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 444.61 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 FormulaC28H36N4O
Molecular Weight444.61 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2014
Nitrogen Atoms4

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