Umeclidinium Impurity 13 CAS 2253743-36-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2253743-36-9
Molecular FormulaC35H38NO2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Umeclidinium Impurity 13 CAS 2253743-36-9 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 584.60 g/mol gives Umeclidinium Impurity 13 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Umeclidinium Impurity 13 (CAS 2253743-36-9) is a certified pharmaceutical impurity reference standard with the molecular formula C35H38NO2Br and a molecular weight of 584.60 g/mol.

The molecular framework of Umeclidinium Impurity 13 (C35H38NO2Br) is characterized by a nitrogen-containing heterocyclic scaffold, 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

As a certified reference material (CRM), Umeclidinium Impurity 13 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC35H38NO2 Br
Molecular Weight584.60 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
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)17.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1998
Halogen ContentBr-containing
Nitrogen Atoms1

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