Tolvaptan Impurity 52 CAS CATO-C4X-195552

Description

The occurrence of Tolvaptan Impurity 52 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Tolvaptan Impurity 52 (CAS CATO-C4X-195552, C52H49Cl2N4O8P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, chlorine substitution, Tolvaptan Impurity 52 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 959.85 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.

As a certified reference material (CRM), Tolvaptan Impurity 52 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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