Itopride Impurity 4 CAS CATO-C4X-13774

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-13774
Molecular FormulaC10H16N2O
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Itopride Impurity 4 CAS CATO-C4X-13774 chemical structure

Description

CATO manufactures Itopride Impurity 4 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

CATO supplies Itopride Impurity 4 (CAS CATO-C4X-13774), a pharmacopoeial impurity reference standard (molecular formula C10H16N2OHCl, MW 216.71 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Itopride Impurity 4 is typically white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 216.71 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

Physical & Chemical Properties

Molecular FormulaC10H16N2O 2*HCl
Molecular Weight216.71 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
Halogen ContentCl-containing
Nitrogen Atoms2

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