Cinitapride Impurity 31 CAS CATO-C4X-290831

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-290831
Molecular FormulaC20H28N4O8
Molecular Weight452.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cinitapride Impurity 31 CAS CATO-C4X-290831 chemical structure

Description

As a process- or degradation-related impurity, Cinitapride Impurity 31 (CAS CATO-C4X-290831, C20H28N4O8) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Cinitapride Impurity 31 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 452.46 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Cinitapride Impurity 31 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 FormulaC20H28N4O8
Molecular Weight452.46 g/mol
AppearancePale yellow to yellow crystalline powder
Purity≥95%
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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