Gadobutrol Impurity 79 CAS 105855-71-8

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 79.

Gadobutrol Impurity 79 (CAS 105855-71-8), molecular formula C22H32N4O4S2 and molecular weight 480.64 g/mol, is a CATO reference standard with documented purity and traceability.

Owing to a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Gadobutrol Impurity 79 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 480.64 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 is suitable for quantitative analysis on major chromatographic platforms including HPLC, GC, LC-MS/MS, and GC-MS, serving as an external calibration standard or a system suitability test reference material.

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

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