Dexmedetomidine Impurity 5 CAS 78892-33-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.78892-33-8
Molecular FormulaC12H14N2O
Molecular Weight202.25 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dexmedetomidine Impurity 5 CAS 78892-33-8 chemical structure

Description

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 process- or degradation-related impurity, Dexmedetomidine Impurity 5 (CAS 78892-33-8, C12H14N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Dexmedetomidine Impurity 5 is typically off-white to pale yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 202.25 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.

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 FormulaC12H14N2O
Molecular Weight202.25 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1979
Nitrogen Atoms2

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