Tramadol EP Impurity D ( and Enantiomer) CAS 80456-81-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.80456-81-1
Molecular FormulaC15H23NO2
Molecular Weight249.35 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tramadol EP Impurity D ( and Enantiomer) CAS 80456-81-1 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.

Tramadol EP Impurity D ( and Enantiomer) (CAS 80456-81-1) is a certified pharmaceutical impurity reference standard with the molecular formula C15H23NO2 and a molecular weight of 249.35 g/mol.

The molecular framework of Tramadol EP Impurity D ( and Enantiomer) (C15H23NO2) 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC15H23NO2
Molecular Weight249.35 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light
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)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1979
Nitrogen Atoms1

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