Bilastine Impurity 60 CAS 2699147-41-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2699147-41-4
Molecular FormulaC31H43N3O3
Molecular Weight505.69 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bilastine Impurity 60 CAS 2699147-41-4 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.

As a process- or degradation-related impurity, Bilastine Impurity 60 (CAS 2699147-41-4, C31H43N3O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Bilastine Impurity 60 (C31H43N3O3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

Physical & Chemical Properties

Molecular FormulaC31H43N3O3
Molecular Weight505.69 g/mol
AppearancePale yellow to yellow crystalline powder
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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2002
Nitrogen Atoms3

Related Bilastine Standards

Recommended Standards

Why CATO?