Cefepime EP Impurity A CAS 97164-57-3

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.97164-57-3
Molecular FormulaC19H24N6O5S2
Molecular Weight480.56 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cefepime EP Impurity A CAS 97164-57-3 chemical structure

Description

The occurrence of Cefepime EP Impurity A is closely related to a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Cefepime EP Impurity A (CAS 97164-57-3) is a certified pharmaceutical impurity reference standard with the molecular formula C19H24N6O5S2 and a molecular weight of 480.56 g/mol.

Structurally, Cefepime EP Impurity A (C19H24N6O5S2) contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 480.56 g/mol, it falls into the moderately-high-molecular-weight range. 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), Cefepime EP Impurity A 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 FormulaC19H24N6O5S2
Molecular Weight480.56 g/mol
Purity>90%
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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1984
Nitrogen Atoms6
Sulfur Atoms2

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