Nateglinide EP Impurity F CAS 944746-48-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.944746-48-9
Molecular FormulaC28H36N2O4
Molecular Weight464.60 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nateglinide EP Impurity F CAS 944746-48-9 chemical structure

Description

Nateglinide EP Impurity F (CAS 944746-48-9) is a certified pharmaceutical impurity reference standard with the molecular formula C28H36N2O4 and a molecular weight of 464.60 g/mol.

Based on its molecular formula C28H36N2O4, Nateglinide EP Impurity F 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 464.60 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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), Nateglinide EP Impurity F 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 FormulaC28H36N2O4
Molecular Weight464.60 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1987
Nitrogen Atoms2

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