Tirzepatide Impurity 22 X TFA Salt CAS CATO-C4X-324022

Description

Compared with other compounds in its class, the molecular weight of 680.79 g/mol gives Tirzepatide Impurity 22 X TFA Salt distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Tirzepatide Impurity 22 X TFA Salt (CAS CATO-C4X-324022) is a certified pharmaceutical impurity reference standard with the molecular formula C33H52N4O11 and a molecular weight of 680.79 g/mol.

Tirzepatide Impurity 22 X TFA Salt (C33H52N4O11) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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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