Gadoteridol Impurity 13 CAS 192329-72-9

Description

Compared with other compounds in its class, the molecular weight of 317.30 g/mol gives Gadoteridol Impurity 13 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Gadoteridol Impurity 13 (CAS 192329-72-9) is a certified pharmaceutical impurity reference standard with the molecular formula C12H19N3O7 and a molecular weight of 317.30 g/mol.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Gadoteridol Impurity 13 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 317.30 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.

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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