Dinoprostone EP Impurity A CAS 38873-82-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.38873-82-4
Molecular FormulaC20H32O5
Molecular Weight352.47 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dinoprostone EP Impurity A CAS 38873-82-4 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.

Dinoprostone EP Impurity A (CAS 38873-82-4) is a certified pharmaceutical impurity reference standard with the molecular formula C20H32O5 and a molecular weight of 352.47 g/mol.

The molecular framework of Dinoprostone EP Impurity A (C20H32O5) is characterized by a steroid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 FormulaC20H32O5
Molecular Weight352.47 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore at room temperature, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1968

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