Dextromethorphan Impurity N1 CAS 69376-27-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.69376-27-8
Molecular FormulaC17H23NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dextromethorphan Impurity N1 CAS 69376-27-8 chemical structure

Description

CATO supplies Dextromethorphan Impurity N1 (CAS 69376-27-8), a pharmacopoeial impurity reference standard (molecular formula C17H23NOHCl, MW 293.83 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Dextromethorphan Impurity N1 (C17H23NOHCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 293.83 g/mol, it falls into the medium-molecular-weight range. 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.

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 FormulaC17H23NO HCl
Molecular Weight293.83 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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1976
Halogen ContentCl-containing
Nitrogen Atoms1

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