Gadobutrol Impurity 1 CAS CATO-C4X-21201

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-21201
Molecular FormulaC20H38N4O10
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gadobutrol Impurity 1 CAS CATO-C4X-21201 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 Gadobutrol Impurity 1.

CATO supplies Gadobutrol Impurity 1 (CAS CATO-C4X-21201), a pharmacopoeial impurity reference standard (molecular formula C20H38N4O10GdCl, MW 687.24 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Gadobutrol Impurity 1 is typically white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 687.24 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), Gadobutrol Impurity 1 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 FormulaC20H38N4O10 Gd Cl
Molecular Weight687.24 g/mol
Purity97%+
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)3.5
UV AbsorptionUV-absorbing
Halogen ContentCl-containing
Nitrogen Atoms4

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