L-Ornithine L-Aspartate Impurity 15 TFA Salt CAS CATO-C4X-253615

Description

The occurrence of L-Ornithine L-Aspartate Impurity 15 TFA Salt is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

L-Ornithine L-Aspartate Impurity 15 TFA Salt (CAS CATO-C4X-253615) is a certified pharmaceutical impurity reference standard with the molecular formula C13H22N4O8C2HF3O2 and a molecular weight of 476.36 g/mol.

L-Ornithine L-Aspartate Impurity 15 TFA Salt (C13H22N4O8C2HF3O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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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