Gadobutrol Impurity 104 4HCl CAS 112193-75-6(free base)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.112193-75-6(free base)
Molecular FormulaC12H24N4O4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gadobutrol Impurity 104 4HCl CAS 112193-75-6(free base) chemical structure

Description

Gadobutrol Impurity 104 4HCl (CAS 112193-75-6(free base)) is a certified pharmaceutical impurity reference standard with the molecular formula C12H24N4O4HCl and a molecular weight of 324.81 g/mol.

Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Gadobutrol Impurity 104 4HCl is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 324.81 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

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.

Physical & Chemical Properties

Molecular FormulaC12H24N4O4 4*HCl
Molecular Weight324.81 g/mol
Purity>95%
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)2.0
Halogen ContentCl-containing
Nitrogen Atoms4

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