Bilastine impurity 86 CAS CATO-C4X-225386

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-225386
Molecular FormulaC14H20ClNO3
Molecular Weight285.77 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bilastine impurity 86 CAS CATO-C4X-225386 chemical structure

Description

CATO manufactures Bilastine impurity 86 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Bilastine impurity 86 (CAS CATO-C4X-225386) is a certified pharmaceutical impurity reference standard with the molecular formula C14H20ClNO3 and a molecular weight of 285.77 g/mol.

Structurally, Bilastine impurity 86 (C14H20ClNO3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 285.77 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.

Physical & Chemical Properties

Molecular FormulaC14H20ClNO3
Molecular Weight285.77 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

Related Bilastine Standards

Recommended Standards

Why CATO?