Tolvaptan Impurity 50 CAS 942619-74-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.942619-74-1
Molecular FormulaC26H26ClN2O6P
Molecular Weight528.92 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tolvaptan Impurity 50 CAS 942619-74-1 chemical structure

Description

CATO supplies Tolvaptan Impurity 50 (CAS 942619-74-1), a pharmacopoeial impurity reference standard (molecular formula C26H26ClN2O6P, MW 528.92 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Tolvaptan Impurity 50 (C26H26ClN2O6P) contains 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 14.5, corresponding to approximately 14 ring(s) or double-bond equivalent(s). With a molecular weight of 528.92 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

Molecular FormulaC26H26ClN2O6P
Molecular Weight528.92 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)14.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1987
Halogen ContentCl-containing
Nitrogen Atoms2

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