Estradiol EP Impurity D-d3 (delta-9(11)-Estradiol-d3) CAS 791-69-5 (non-labelled)

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.791-69-5 (non-labelled)
Molecular Formula-
Molecular Weight273.38 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Estradiol EP Impurity D-d3 (delta-9(11)-Estradiol-d3) CAS 791-69-5 (non-labelled) 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.

Estradiol EP Impurity D-d3 (delta-9(11)-Estradiol-d3) (CAS 791-69-5 (non-labelled)) is a certified pharmaceutical impurity reference standard with the molecular formula C18H19D3O2 and a molecular weight of 273.38 g/mol.

The molecular framework of Estradiol EP Impurity D-d3 (delta-9(11)-Estradiol-d3) (C18H19D3O2) is characterized by deuterium isotope labeling, a steroid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC18H19D3O2
Molecular Weight273.38 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
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)9.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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