Dienogest EP Impurity H CAS 16669-06-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.16669-06-0
Molecular FormulaC20H25NO2
Molecular Weight311.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dienogest EP Impurity H CAS 16669-06-0 chemical structure

Description

CATO supplies Dienogest EP Impurity H (CAS 16669-06-0), a pharmacopoeial impurity reference standard (molecular formula C20H25NO2, MW 311.42 g/mol) used for the identification and quantification of trace impurities in APIs.

Dienogest EP Impurity H (C20H25NO2) 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 high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

CATO manufactures Dienogest EP Impurity H under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC20H25NO2
Molecular Weight311.42 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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1961
Nitrogen Atoms1

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