Duloxetine EP Impurity C HBr CAS 949096-01-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.949096-01-9
Molecular FormulaC18H19NOS
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Duloxetine EP Impurity C HBr CAS 949096-01-9 chemical structure

Description

Duloxetine EP Impurity C HBr (CAS 949096-01-9) is a certified pharmaceutical impurity reference standard with the molecular formula C18H19NOSHBr and a molecular weight of 378.33 g/mol.

Based on its molecular formula C18H19NOSHBr, Duloxetine EP Impurity C HBr contains a steroid core, an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage, bromine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 378.33 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC18H19NOS HBr
Molecular Weight378.33 g/mol
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1987
Halogen ContentBr-containing
Nitrogen Atoms1
Sulfur Atoms1

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