Umeclidinium Impurity 17 CAS CATO-C4X-133917

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-133917
Molecular FormulaC23H28NO2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Umeclidinium Impurity 17 CAS CATO-C4X-133917 chemical structure

Description

CATO supplies Umeclidinium Impurity 17 (CAS CATO-C4X-133917), a pharmacopoeial impurity reference standard (molecular formula C23H28NO2Br, MW 430.39 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Umeclidinium Impurity 17 (C23H28NO2Br) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 FormulaC23H28NO2 Br
Molecular Weight430.39 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing
Nitrogen Atoms1

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