Cinitapride Impurity 18 CAS CATO-C4X-290818

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-290818
Molecular FormulaC12H16N4O4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cinitapride Impurity 18 CAS CATO-C4X-290818 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 316.74 g/mol gives Cinitapride Impurity 18 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Cinitapride Impurity 18 (CAS CATO-C4X-290818), a pharmacopoeial impurity reference standard (molecular formula C12H16N4O4HCl, MW 316.74 g/mol) used for the identification and quantification of trace impurities in APIs.

Cinitapride Impurity 18 (C12H16N4O4HCl) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, 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).

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 FormulaC12H16N4O4 HCl
Molecular Weight316.74 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms4

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