Dienogest EP Impurity L CAS 5571-36-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.5571-36-8
Molecular FormulaC20H26O3
Molecular Weight314.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dienogest EP Impurity L CAS 5571-36-8 chemical structure

Description

CATO manufactures Dienogest EP Impurity L 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.

As a process- or degradation-related impurity, Dienogest EP Impurity L (CAS 5571-36-8, C20H26O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Dienogest EP Impurity L (C20H26O3) contains a steroid core, 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.

Physical & Chemical Properties

Molecular FormulaC20H26O3
Molecular Weight314.42 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958

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