Umeclidinium bromide Impurity 21 CAS 40117-63-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.40117-63-3
Molecular FormulaC8H13NO2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Umeclidinium bromide Impurity 21 CAS 40117-63-3 chemical structure

Description

The occurrence of Umeclidinium bromide Impurity 21 is closely related to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Umeclidinium bromide Impurity 21 (CAS 40117-63-3, C8H13NO2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C8H13NO2HCl, Umeclidinium bromide Impurity 21 contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 191.66 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

CATO manufactures Umeclidinium bromide Impurity 21 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.

Physical & Chemical Properties

Molecular FormulaC8H13NO2 HCl
Molecular Weight191.66 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1968
Halogen ContentCl-containing
Nitrogen Atoms1

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