Duloxetine Impurity 35 CAS CATO-C4X-133635

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-133635
Molecular FormulaC18H18N2O2S
Molecular Weight326.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Duloxetine Impurity 35 CAS CATO-C4X-133635 chemical structure

Description

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.

As a process- or degradation-related impurity, Duloxetine Impurity 35 (CAS CATO-C4X-133635, C18H18N2O2S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Duloxetine Impurity 35 (C18H18N2O2S) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. It is notably hygroscopic, its high carbon-to-hydrogen ratio confers good lipid solubility, 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).

CATO manufactures Duloxetine Impurity 35 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC18H18N2O2S
Molecular Weight326.41 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2
Sulfur Atoms1

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