Ethinylestradiol EP Impurity B CAS 1231-96-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1231-96-5
Molecular FormulaC20H22O2
Molecular Weight294.39 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ethinylestradiol EP Impurity B CAS 1231-96-5 chemical structure

Description

As a certified reference material (CRM), Ethinylestradiol EP Impurity B meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Ethinylestradiol EP Impurity B (CAS 1231-96-5) is a certified pharmaceutical impurity reference standard with the molecular formula C20H22O2 and a molecular weight of 294.39 g/mol.

Owing to a steroid core, a hydroxyl group, an ether linkage, Ethinylestradiol EP Impurity B is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 294.39 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC20H22O2
Molecular Weight294.39 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957

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