Gadobutrol Impurity 125 CAS 156077-56-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.156077-56-4
Molecular FormulaC12H28N4O3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gadobutrol Impurity 125 CAS 156077-56-4 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 125 (CAS 156077-56-4), a pharmacopoeial impurity reference standard (molecular formula C12H28N4O3HCl, MW 312.84 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 125 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 312.84 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 FormulaC12H28N4O3 4*HCl
Molecular Weight312.84 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)0.0
CAS Registry Year (est.)2001
Halogen ContentCl-containing
Nitrogen Atoms4

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