Tolvaptan Impurity 102 CAS CATO-C4X-1955102

Description

The occurrence of Tolvaptan Impurity 102 is closely related to a salt form, a steroid core, 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.

Tolvaptan Impurity 102 (CAS CATO-C4X-1955102) is a certified pharmaceutical impurity reference standard with the molecular formula C26H24ClN2Na2O6P and a molecular weight of 572.88 g/mol.

Structurally, Tolvaptan Impurity 102 (C26H24ClN2Na2O6P) contains a salt form, a steroid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 15.5, corresponding to approximately 15 ring(s) or double-bond equivalent(s). With a molecular weight of 572.88 g/mol, it falls into the moderately-high-molecular-weight range. 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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