Gadobutrol Impurity 182 CAS CATO-C4X-2120182

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-2120182
Molecular FormulaC18H32N4O8
Molecular Weight432.47 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gadobutrol Impurity 182 CAS CATO-C4X-2120182 chemical structure

Description

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.

CATO supplies Gadobutrol Impurity 182 (CAS CATO-C4X-2120182), a pharmacopoeial impurity reference standard (molecular formula C18H32N4O8, MW 432.47 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Gadobutrol Impurity 182 (C18H32N4O8) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC18H32N4O8
Molecular Weight432.47 g/mol
AppearanceOff-white to pale 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)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms4

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