Cefamandole Impurity 35 CAS CATO-C4X-122135

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-122135
Molecular FormulaC12H14N6O4S2
Molecular Weight370.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cefamandole Impurity 35 CAS CATO-C4X-122135 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Cefamandole Impurity 35.

CATO supplies Cefamandole Impurity 35 (CAS CATO-C4X-122135), a pharmacopoeial impurity reference standard (molecular formula C12H14N6O4S2, MW 370.41 g/mol) used for the identification and quantification of trace impurities in APIs.

Cefamandole Impurity 35 (C12H14N6O4S2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC12H14N6O4S2
Molecular Weight370.41 g/mol
Purity97%+
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms6
Sulfur Atoms2

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