Phenytoin EP Impurity E CAS 6802-95-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.6802-95-5
Molecular FormulaC15H14N2O3
Molecular Weight270.28 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Phenytoin EP Impurity E CAS 6802-95-5 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 270.28 g/mol gives Phenytoin EP Impurity E distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Phenytoin EP Impurity E (CAS 6802-95-5) is a certified pharmaceutical impurity reference standard with the molecular formula C15H14N2O3 and a molecular weight of 270.28 g/mol.

The molecular framework of Phenytoin EP Impurity E (C15H14N2O3) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing 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).

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.

CATO manufactures Phenytoin EP Impurity E under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC15H14N2O3
Molecular Weight270.28 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 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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958
Nitrogen Atoms2

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