Ganaxolone Impurity 1 CAS 1264737-31-6

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1264737-31-6
Molecular FormulaC22H36O2
Molecular Weight332.52 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ganaxolone Impurity 1 CAS 1264737-31-6 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, Ganaxolone Impurity 1 (CAS 1264737-31-6, C22H36O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C22H36O2, Ganaxolone Impurity 1 contains a steroid core, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 332.52 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

As a certified reference material (CRM), Ganaxolone Impurity 1 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.

Physical & Chemical Properties

Molecular FormulaC22H36O2
Molecular Weight332.52 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore at room temperature
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1990

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