Dienogest EP Impurity G CAS 86153-38-0

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.86153-38-0
Molecular FormulaC20H23NO2
Molecular Weight309.40 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dienogest EP Impurity G CAS 86153-38-0 chemical structure

Description

As a process- or degradation-related impurity, Dienogest EP Impurity G (CAS 86153-38-0, C20H23NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Dienogest EP Impurity G (C20H23NO2) contains a steroid core, an amide 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.

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 FormulaC20H23NO2
Molecular Weight309.40 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>90%
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.)1981
Nitrogen Atoms1

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