Tamoxifen Impurity 11 CAS 5435-24-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.5435-24-5
Molecular FormulaC20H18O3S
Molecular Weight338.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tamoxifen Impurity 11 CAS 5435-24-5 chemical structure

Description

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.

Tamoxifen Impurity 11 (CAS 5435-24-5) is a certified pharmaceutical impurity reference standard with the molecular formula C20H18O3S and a molecular weight of 338.42 g/mol.

Tamoxifen Impurity 11 (C20H18O3S) contains a steroid core, a sulfone group, a hydroxyl group, an ether linkage. 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).

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.

Physical & Chemical Properties

Molecular FormulaC20H18O3S
Molecular Weight338.42 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958
Sulfur Atoms1

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