Sivelestat Impurity 17 CAS 10167-30-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.10167-30-3
Molecular FormulaC11H13N3O4
Molecular Weight251.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sivelestat Impurity 17 CAS 10167-30-3 chemical structure

Description

CATO supplies Sivelestat Impurity 17 (CAS 10167-30-3), a pharmacopoeial impurity reference standard (molecular formula C11H13N3O4, MW 251.24 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C11H13N3O4, Sivelestat Impurity 17 contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 251.24 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.

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 FormulaC11H13N3O4
Molecular Weight251.24 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 methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1959
Nitrogen Atoms3

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