Dienogest EP Impurity D CAS 190662-30-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.190662-30-7
Molecular FormulaC22H29NO3
Molecular Weight355.47 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dienogest EP Impurity D CAS 190662-30-7 chemical structure

Description

Dienogest EP Impurity D (CAS 190662-30-7) is a certified pharmaceutical impurity reference standard with the molecular formula C22H29NO3 and a molecular weight of 355.47 g/mol.

Based on its molecular formula C22H29NO3, Dienogest EP Impurity D contains a steroid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 355.47 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.

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 certified reference material (CRM), Dienogest EP Impurity D 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 FormulaC22H29NO3
Molecular Weight355.47 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.)2011
Nitrogen Atoms1

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