Doxofylline Impurity 13 CAS 43135-57-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.43135-57-5
Molecular FormulaC13H20N4O4
Molecular Weight296.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Doxofylline Impurity 13 CAS 43135-57-5 chemical structure

Description

Doxofylline Impurity 13 (CAS 43135-57-5) is a certified pharmaceutical impurity reference standard with the molecular formula C13H20N4O4 and a molecular weight of 296.32 g/mol.

Based on its molecular formula C13H20N4O4, Doxofylline Impurity 13 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 296.32 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.

As a certified reference material (CRM), Doxofylline Impurity 13 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 FormulaC13H20N4O4
Molecular Weight296.32 g/mol
AppearanceOff-white to pale 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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1969
Nitrogen Atoms4

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