Indobufen Impurity 39 CAS 13048-83-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.13048-83-4
Molecular FormulaC10H9NO4
Molecular Weight207.18 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Indobufen Impurity 39 CAS 13048-83-4 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 207.18 g/mol gives Indobufen Impurity 39 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Indobufen Impurity 39 (CAS 13048-83-4), a pharmacopoeial impurity reference standard (molecular formula C10H9NO4, MW 207.18 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Indobufen Impurity 39 (C10H9NO4) 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.

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 FormulaC10H9NO4
Molecular Weight207.18 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity97%+
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.)1960
Nitrogen Atoms1

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