Raloxifene EP Impurity C CAS 195454-31-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.195454-31-0
Molecular FormulaC28H27NO5S
Molecular Weight489.58 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Raloxifene EP Impurity C CAS 195454-31-0 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.

CATO supplies Raloxifene EP Impurity C (CAS 195454-31-0), a pharmacopoeial impurity reference standard (molecular formula C28H27NO5S, MW 489.58 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Raloxifene EP Impurity C is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 489.58 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).

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 FormulaC28H27NO5S
Molecular Weight489.58 g/mol
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)16.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2012
Nitrogen Atoms1
Sulfur Atoms1

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