Doxepin EP Impurity D CAS 3607-18-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.3607-18-9
Molecular FormulaC19H21NO
Molecular Weight279.38 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Doxepin EP Impurity D CAS 3607-18-9 chemical structure

Description

Doxepin EP Impurity D (CAS 3607-18-9) is a certified pharmaceutical impurity reference standard with the molecular formula C19H21NO and a molecular weight of 279.38 g/mol.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Doxepin EP Impurity D is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 279.38 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

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 FormulaC19H21NO
Molecular Weight279.38 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958
Nitrogen Atoms1

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