Dydrogesterone Impurity 21 CAS CATO-C4X-218321

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-218321
Molecular FormulaC25H34O4
Molecular Weight398.54 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dydrogesterone Impurity 21 CAS CATO-C4X-218321 chemical structure

Description

As a process- or degradation-related impurity, Dydrogesterone Impurity 21 (CAS CATO-C4X-218321, C25H34O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Dydrogesterone Impurity 21 (C25H34O4) contains a flavonoid 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 Dydrogesterone Impurity 21 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 FormulaC25H34O4
Molecular Weight398.54 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
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

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