Ampicillin Trihydrate EP Impurity N CAS CATO-C4X-144353

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-144353
Molecular FormulaC16H19N3O4S
Molecular Weight349.40 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ampicillin Trihydrate EP Impurity N CAS CATO-C4X-144353 chemical structure

Description

CATO supplies Ampicillin Trihydrate EP Impurity N (CAS CATO-C4X-144353), a pharmacopoeial impurity reference standard (molecular formula C16H19N3O4S, MW 349.40 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C16H19N3O4S, Ampicillin Trihydrate EP Impurity N contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 349.40 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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), Ampicillin Trihydrate EP Impurity N 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 FormulaC16H19N3O4S
Molecular Weight349.40 g/mol
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms3
Sulfur Atoms1

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