Difelikefalin Impurity 26 CAS CATO-C4X-304126

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-304126
Molecular FormulaC12H24N4O3
Molecular Weight272.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Difelikefalin Impurity 26 CAS CATO-C4X-304126 chemical structure

Description

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.

As a process- or degradation-related impurity, Difelikefalin Impurity 26 (CAS CATO-C4X-304126, C12H24N4O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Difelikefalin Impurity 26 (C12H24N4O3) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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).

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.

Physical & Chemical Properties

Molecular FormulaC12H24N4O3
Molecular Weight272.34 g/mol
AppearanceWhite to pale yellow crystalline powder
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
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
Nitrogen Atoms4

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