Dextromethorphan Impurity 33 CAS 89511-04-6

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.89511-04-6
Molecular FormulaC17H21NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dextromethorphan Impurity 33 CAS 89511-04-6 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Dextromethorphan Impurity 33.

As a process- or degradation-related impurity, Dextromethorphan Impurity 33 (CAS 89511-04-6, C17H21NOHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C17H21NOHCl, Dextromethorphan Impurity 33 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 291.82 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 FormulaC17H21NO HCl
Molecular Weight291.82 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1982
Halogen ContentCl-containing
Nitrogen Atoms1

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