Dydrogesterone Impurity 22 CAS CATO-C4X-218322

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-218322
Molecular FormulaC42H54O3
Molecular Weight606.88 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dydrogesterone Impurity 22 CAS CATO-C4X-218322 chemical structure

Description

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.

As a process- or degradation-related impurity, Dydrogesterone Impurity 22 (CAS CATO-C4X-218322, C42H54O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system, Dydrogesterone Impurity 22 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 606.88 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC42H54O3
Molecular Weight606.88 g/mol
Purity≥95%
StorageStore at room temperature, 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)16.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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