Fingolimod EP Impurity B (Fingolimod Heptyl Impurity) CAS 745767-97-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.745767-97-9
Molecular FormulaC18H31NO2
Molecular Weight293.44 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fingolimod EP Impurity B (Fingolimod Heptyl Impurity) CAS 745767-97-9 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 293.44 g/mol gives Fingolimod EP Impurity B (Fingolimod Heptyl Impurity) distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Fingolimod EP Impurity B (Fingolimod Heptyl Impurity) (CAS 745767-97-9) is a certified pharmaceutical impurity reference standard with the molecular formula C18H31NO2 and a molecular weight of 293.44 g/mol.

Based on its molecular formula C18H31NO2, Fingolimod EP Impurity B (Fingolimod Heptyl Impurity) 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 293.44 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

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 FormulaC18H31NO2
Molecular Weight293.44 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light
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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1986
Nitrogen Atoms1

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