Tolvaptan Impurity 54 CAS 1118884-66-4

Description

The occurrence of Tolvaptan Impurity 54 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Tolvaptan Impurity 54 (CAS 1118884-66-4) is a certified pharmaceutical impurity reference standard with the molecular formula C17H17NO3 and a molecular weight of 283.32 g/mol.

Based on its molecular formula C17H17NO3, Tolvaptan Impurity 54 contains a steroid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 283.32 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

As a certified reference material (CRM), Tolvaptan Impurity 54 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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