Duloxetine Impurity CAS 116539-57-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.116539-57-2
Molecular FormulaC8H13NOS
Molecular Weight171.26 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Duloxetine Impurity CAS 116539-57-2 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 Duloxetine Impurity.

Duloxetine Impurity (CAS 116539-57-2) is a certified pharmaceutical impurity reference standard with the molecular formula C8H13NOS and a molecular weight of 171.26 g/mol.

Based on its molecular formula C8H13NOS, Duloxetine Impurity contains an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 171.26 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC8H13NOS
Molecular Weight171.26 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1990
Nitrogen Atoms1
Sulfur Atoms1

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