Daprodustat Impurity 35 CAS CATO-C4X-240735

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-240735
Molecular FormulaC29H46N4O3
Molecular Weight498.70 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Daprodustat Impurity 35 CAS CATO-C4X-240735 chemical structure

Description

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.

CATO supplies Daprodustat Impurity 35 (CAS CATO-C4X-240735), a pharmacopoeial impurity reference standard (molecular formula C29H46N4O3, MW 498.70 g/mol) used for the identification and quantification of trace impurities in APIs.

Daprodustat Impurity 35 (C29H46N4O3) contains a steroid core, an amide 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).

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 FormulaC29H46N4O3
Molecular Weight498.70 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore in a cool place (≤25°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 Atoms4

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