Gadoxetate Impurity 31 CAS CATO-C4X-261831

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-261831
Molecular FormulaC12H20N2O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gadoxetate Impurity 31 CAS CATO-C4X-261831 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Gadoxetate Impurity 31.

CATO supplies Gadoxetate Impurity 31 (CAS CATO-C4X-261831), a pharmacopoeial impurity reference standard (molecular formula C12H20N2O2HCl, MW 260.76 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C12H20N2O2HCl, Gadoxetate Impurity 31 contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 260.76 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

CATO manufactures Gadoxetate Impurity 31 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.

Physical & Chemical Properties

Molecular FormulaC12H20N2O2 3*HCl
Molecular Weight260.76 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry, 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; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
Halogen ContentCl-containing
Nitrogen Atoms2

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