Tamoxifen EP Impurity D Oxalate (Mixture of Z and E Isomers) CAS CATO-C4X-123314

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-123314
Molecular FormulaC25H27NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tamoxifen EP Impurity D Oxalate (Mixture of Z and E Isomers) CAS CATO-C4X-123314 chemical structure

Description

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Tamoxifen EP Impurity D Oxalate (Mixture of Z and E Isomers) is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 447.53 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a process- or degradation-related impurity, Tamoxifen EP Impurity D Oxalate (Mixture of Z and E Isomers) (CAS CATO-C4X-123314, C25H27NOC2H2O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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 FormulaC25H27NO C2H2O4
Molecular Weight447.53 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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