Umeclidinium Impurity 7 CAS CATO-C4X-13397

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-13397
Molecular FormulaC19H28NO3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Umeclidinium Impurity 7 CAS CATO-C4X-13397 chemical structure

Description

CATO supplies Umeclidinium Impurity 7 (CAS CATO-C4X-13397), a pharmacopoeial impurity reference standard (molecular formula C19H28NO3Br, MW 398.34 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution, Umeclidinium Impurity 7 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 398.34 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 7 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 FormulaC19H28NO3 Br
Molecular Weight398.34 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
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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing
Nitrogen Atoms1

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