Cefuroxime Sodium EP Impurity I(Ammonium Salt) CAS 97148-39-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.97148-39-5
Molecular FormulaC7H6NO4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cefuroxime Sodium EP Impurity I(Ammonium Salt) CAS 97148-39-5 chemical structure

Description

As a certified reference material (CRM), Cefuroxime Sodium EP Impurity I(Ammonium Salt) 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.

CATO supplies Cefuroxime Sodium EP Impurity I(Ammonium Salt) (CAS 97148-39-5), a pharmacopoeial impurity reference standard (molecular formula C7H6NO4H4N, MW 186.17 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Cefuroxime Sodium EP Impurity I(Ammonium Salt) (C7H6NO4H4N) is characterized by an amino-acid-derived structure, 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 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.

Physical & Chemical Properties

Molecular FormulaC7H6NO4 H4N
Molecular Weight186.17 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1984
Nitrogen Atoms2

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