Dexmedetomidine Impurity 29 CAS 176721-02-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.176721-02-1
Molecular FormulaC31H26N2O
Molecular Weight442.55 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dexmedetomidine Impurity 29 CAS 176721-02-1 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, Dexmedetomidine Impurity 29 (CAS 176721-02-1, C31H26N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Dexmedetomidine Impurity 29 (C31H26N2O) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC31H26N2O
Molecular Weight442.55 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)20.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2007
Nitrogen Atoms2

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