Drospirenone EP Impurity A CAS 67372-68-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.67372-68-3
Molecular FormulaC23H30O3
Molecular Weight354.48 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Drospirenone EP Impurity A CAS 67372-68-3 chemical structure

Description

As a certified reference material (CRM), Drospirenone EP Impurity A 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.

As a process- or degradation-related impurity, Drospirenone EP Impurity A (CAS 67372-68-3, C23H30O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Drospirenone EP Impurity A (C23H30O3) 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 FormulaC23H30O3
Molecular Weight354.48 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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1976

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