Phenylbutyrate Impurity 14 CAS 358349-85-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.358349-85-6
Molecular FormulaC13H18O2
Molecular Weight206.28 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Phenylbutyrate Impurity 14 CAS 358349-85-6 chemical structure

Description

As a process- or degradation-related impurity, Phenylbutyrate Impurity 14 (CAS 358349-85-6, C13H18O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system, Phenylbutyrate Impurity 14 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 206.28 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 FormulaC13H18O2
Molecular Weight206.28 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore at room temperature
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025

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