Duloxetine Impurity CAS 199191-67-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.199191-67-8
Molecular FormulaC26H23NO4S
Molecular Weight445.53 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Duloxetine Impurity CAS 199191-67-8 chemical structure

Description

Duloxetine Impurity (CAS 199191-67-8) is a certified pharmaceutical impurity reference standard with the molecular formula C26H23NO4S and a molecular weight of 445.53 g/mol.

Duloxetine Impurity (C26H23NO4S) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC26H23NO4S
Molecular Weight445.53 g/mol
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)16.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2013
Nitrogen Atoms1
Sulfur Atoms1

Related Duloxetine Standards

Recommended Standards

Why CATO?