Tegoprazan Impurity 113 CAS CATO-C4X-2297113

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-2297113
Molecular FormulaC17H16N2O3
Molecular Weight296.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tegoprazan Impurity 113 CAS CATO-C4X-2297113 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 Tegoprazan Impurity 113.

CATO supplies Tegoprazan Impurity 113 (CAS CATO-C4X-2297113), a pharmacopoeial impurity reference standard (molecular formula C17H16N2O3, MW 296.32 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C17H16N2O3, Tegoprazan Impurity 113 contains a steroid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 296.32 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 FormulaC17H16N2O3
Molecular Weight296.32 g/mol
AppearancePale yellow to yellow crystalline powder
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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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