Otilonium Bromide Impurity 3 CAS 14629-01-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.14629-01-7
Molecular FormulaC14H23N2O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Otilonium Bromide Impurity 3 CAS 14629-01-7 chemical structure

Description

Structurally, Otilonium Bromide Impurity 3 (C14H23N2O2Br) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, bromine substitution. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 331.25 g/mol, it falls into the moderately-high-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

CATO supplies Otilonium Bromide Impurity 3 (CAS 14629-01-7), a pharmacopoeial impurity reference standard (molecular formula C14H23N2O2Br, MW 331.25 g/mol) used for the identification and quantification of trace impurities in APIs.

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 FormulaC14H23N2O2 Br
Molecular Weight331.25 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1961
Halogen ContentBr-containing
Nitrogen Atoms2

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