Bilastine Impurity 48 CAS CATO-C4X-225348

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-225348
Molecular FormulaC38H47N3O5
Molecular Weight625.80 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bilastine Impurity 48 CAS CATO-C4X-225348 chemical structure

Description

CATO supplies Bilastine Impurity 48 (CAS CATO-C4X-225348), a pharmacopoeial impurity reference standard (molecular formula C38H47N3O5, MW 625.80 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Bilastine Impurity 48 (C38H47N3O5) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC38H47N3O5
Molecular Weight625.80 g/mol
Purity>95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)17.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms3

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