Iodixanol Impurity 11 CAS CATO-C4X-166311

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-166311
Molecular FormulaC28H34I6N6O12
Molecular Weight1408.03 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Iodixanol Impurity 11 CAS CATO-C4X-166311 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.

As a process- or degradation-related impurity, Iodixanol Impurity 11 (CAS CATO-C4X-166311, C28H34I6N6O12) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, iodine substitution, Iodixanol Impurity 11 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 1408.03 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC28H34I6N6O12
Molecular Weight1408.03 g/mol
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentI-containing
Nitrogen Atoms6

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