Duloxetine EP Impurity B CAS 116539-55-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.116539-55-0
Molecular FormulaC8H13NOS
Molecular Weight171.26 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Duloxetine EP Impurity B CAS 116539-55-0 chemical structure

Description

CATO supplies Duloxetine EP Impurity B (CAS 116539-55-0), a pharmacopoeial impurity reference standard (molecular formula C8H13NOS, MW 171.26 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Duloxetine EP Impurity B (C8H13NOS) contains an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 171.26 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 FormulaC8H13NOS
Molecular Weight171.26 g/mol
Purity>95%
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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